MORE THAN 150 PARTICIPANTS, among them your peers, advisers, clients and potential business partners
If you are looking to expand or improve your pharmaceutical business in Africa, this Summit provides a brand NEW platform allowing participants to learn about opportunities, regulation and challenges within the Region.
We invite the regulators, industry professionals and experts from Africa.
We’re going virtual. Stay tuned!
Government & industry Speakers
Hurry up, register!
Mr. Sidibé is a renowned tireless champion of African-owned solutions and has been an outspoken advocate for local pharmaceutical production of medicines and other essential health commodities. He contributed to the efforts towards access to quality and safe medicines and vaccines and in fighting global inequities.
In April 2021, he was appointed African Union Special Envoy for AMA. Thanks to his high-level advocacy efforts, the treaty entered into force on 5 November, much more quickly than expected.
A former Minister of Health and Social Affairs for Mali (2019-2020), Sidibé has championed a people centered approach to health and development for over 40 years.
He served as Executive Director of UNAIDS, holding the rank of Under-Secretary-General of the United Nations (2009-2019). Prior to joining UNAIDS, Mr. Sidibé worked at UNICEF and for Terre des Hommes, where his passion for advancing global health and social justice began.
Under his leadership at UNAIDS, more than 25 million people started life saving HIV treatment.
In 2021 he was appointed a board member of The Global Commission on Drug Policy.
An economist by training, Michel Hamala Mr. Sidibé is the recipient of various African and global awards, including honorary doctorates from world’s leading universities.
Samuel Asante-Boateng is a Ghanaian by birth and about 56 years of age. He is a professional pharmacist trained at the Kwame Nkrumah University of Science and Technology (KNUST) Ghana 30 years ago and has also done further studies in MSc Pharm. Technology at the University of Bradford in UK. He has taken certificate courses in leadership, management and administration at the Ghana Institute of management and Public Administration (GIMPA). He currently works with the FDA Ghana as the Head of the Drugs and Herbal medicine Registration Directorate. He has been working in regulation for the past 17years. Before joining the FDA, Samuel Asante-Boateng worked in the pharmaceutical industry in Ghana for 12years.
He is part of the team of assessors at the FDA Ghana for the past 14years and has also participated in a lot of foreign GMP inspections.
In support of the West Africa Medicine Regulation Harmonization (WA-MRH) project, Samuel has been working as the chairman of the Expert Working Group for Medical Product Dossier Evaluation and Registration (EWG-MPDER) involved in the Regional joint assessment procedure in the ECOWAS region since its commencement in the year 2017.
Margareth Ndomondo-Sigonda, works for AUDA-NEPAD as the Head of Programme. She is responsible for providing technical lead and strategic oversight on health and pharmaceutical programs such as the African Medicines Regulatory Harmonization (AMRH) Initiative, the establishment of African Medicines Agency as a specialized agency of the African Union (AU), and promotion of local production of pharmaceuticals in Africa. She currently leads the regulatory workstream of the AU Partnerships for African Vaccines Manufacturing (PAVM) Framework.
She previously served as Chief Pharmacist and Registrar of Pharmacy Board of Tanzania (1998-2003) and as the first Director General of the Tanzania Food and Drugs Authority (2003-2010).
She holds a PhD in Pharmacology from the University of the Witwatersrand, Johannesburg, South Africa.
A Pharmacist with 33 years’ experience and 23 years’ experience as Pharmaceutical and Quality Assurance Analyst. She holds MSc. in Pharmaceutical and Quality Control (1999) from KNUST-Ghana and currently a PhD candidate in Public Health Administration and Policy. She is a Fellow of the West Africa Postgraduate College of Pharmacists (2018) as well as a Fellow Ghana Post Graduate College of Pharmacists (2016).
Sybil has been working with WAHO for the past 12 years as the Professional Officer in charge of Pharmaceuticals, and now the Ag. Principal Program Officer and Head of Public Health Division. She has expertise in policy and strategic plan development, medicines regulatory systems, quality control systems for laboratories, ensuring the accreditations of the national regulatory agencies and laboratories to international standards, building local pharmaceutical manufacturing capacities and establishing good manufacturing practices. She has coordinated the ECOWAS Regional Medicines Regulatory Harmonization process since 2014, trained and developed regional experts in the pharmaceutical sectors to strengthen the human resource for the work force, as well as led various initiatives to improve access to quality, safe and affordable medical products in the ECOWAS region. Has good working relationships with stakeholders and partners. Currently coordinating the ECOWAS COVID-19 vaccines Taskforce to ensure effective access of COVID-19 vaccines and other vaccines production in the region.
Dr Manal Younus is currently the head of Iraqi Pharmacovigilance Center based in MOH. Manal is a pharmacist with a Ph.D. in Clinical Pharmacy. Key achievements include the establishment and the expansion of the Iraqi pharmacovigilance system. Represent Iraq in the WHO international drug monitoring program (PIDM). She is an International Society of Pharmacovigilance (ISoP) Advisory Board member and represent ISoP in the Council of International Organizations of Medical Sciences (CIOMS). Manal is the vice president of the ISoP Middle East chapter, ISoP Pharmacovigilance Professional Qualification Framework SIG member and she had authored more than 30 articles in different drug safety related subjects. Finally, a member of the specialized committee for Antimicrobial Resistance of the International Academy of Public Health (IAPH).
In addition to his current title, he is also the founding Deputy Director, and, in these roles, he has led the strategic work and oversight of Africa CDC. He works closely with African Union Member States and partners to deliver on the mandate of Africa CDC of preventing and controlling diseases in Africa.
Ahmed has led the operations of Africa CDC during the COVID-19 pandemic, coordinating the planning, acquisition, and delivery of life-saving health products to African countries including test kits, personal protective materials, therapeutics, and vaccines. Formerly, he worked with the WHO at both the HQs and Regional Office for Africa, in combating NCDs & tobacco control.
Prior to that, Dr. Ahmed worked at country level in the Ministry of Health, Kenya, as Director for NCDs and then Head of the Office for International Health Relations. He has been at the forefront of advocacy and action to reform the health system in Africa including the need to establish an efficient & effective response mechanism for disease threats and health emergencies. He has over 25 years’ experience in public health and is an alumnus of the University of Nairobi in Kenya and the University of Bergen in Norway.
S/Directrice de l’Homologation des Médicaments et des Autres Produits Pharmaceutiques – AIRP
Membre de la Commission Nationale du Médicament et des autres Produits Pharmaceutiques (CNMPP) représentant l’AIRP
Membre du comité des experts pour l’évaluation technique des demandes d’homologation
Pharmacien inspecteur assermenté au sein de l’AIRP depuis Juin 2022
Experte en Affaires règlementaires avec plus de 15 ans d’expérience dans l’Industrie Pharmaceutique
Membre fondateur de l’ARAF (Association des Règlementaires de l’Afrique Francophone) créé en 2009
Ancien membre des GTT organisés par le LEEM.
Dr. Janet Byaruhanga is a qualified medical doctor and public health expert that obtained her postgraduate diploma in public health research from the University of Edinburgh and has over 14 years of experience in international development with special focus in human and social sectors. Served as health policy officer at the African Union Commission since 2007 where she provided technical leadership and oversight in development and delivery of key strategic continental policy frameworks, programmes and initiatives geared towards strengthening the continent’s healthcare delivery system, food security and nutrition, and promoting the social well-being and rights of women and children.
Dr. Byaruhanga since 1st September 2017 joined the African Union Development Agency- NEPAD as a Senior Programme Officer-Health. She is in charge of coordinating and facilitating development and implementation of policies on health and medical products and ensuring their alignment with industrial development; trade; science, technology and innovation polices in advancement of the African Union’s African Health Strategy and the Pharmaceutical Manufacturing Plan for Africa (PMPA).
She is a registered pharmacist with an MSc in Pharmaceutics (Bioavailability). After spending 22 years in the pharmaceutical industry in regulatory affairs, quality assurance and pharmacovigilance roles with companies such as Merck KGaA, Boehringer Ingelheim and Merck Sharp & Dohme, she joined the South African Medicines Regulator, SAHPRA, in June 2020 to head up the organisation’s Backlog Clearance Programme. When SAHPRA was established in 2018, it inherited approx. 16,000 in-process applications from its predecessor, the Medicine Control Council.
A dedicated Programme was set up to clear the application backlog and, to date, the backlog is 99% finalised due to the various initiatives piloted and implemented within the project.
- Passionate about Health Products Regulation
- Access to Safe, Quality & Efficacious Health Products
- Motivated by success
- Favorites: Music, Fitness, Travelling, Sport
- Pharm (Hons), PG DiP Medicines Development & MBA
- Senior Manager at SAHPRA since Jan 2021
- Regulatory Officer/ Assessor at MCAZ (2.5 yrs.)
- Regulatory Affairs in Pharma (6.5 yrs.) & FMCG (1.5yrs)
- 5 years’ experience in R&D
Florah is a pharmacist by profession currently heading the pharmacovigilance unit of South African Health Products Regulatory Authority (SAHPRA). She holds BPharm and master’s in pharmacy with specialisation in Pharmacovigilance & Pharmacoepidemiology. She joined SAHPRA in 2011 as Medicine Registration Officer in the Pharmaceutical & Analytical Directorate and later Head the Vigilance unit since October 2015 to date. She has experience in different pharmacy sectors, including medicines regulation, retail and hospital pharmacy. She has attended different pharmacovigilance courses offered internationally including training by Uppsala Monitoring Centre.
She supports the National Immunisation Safety Expert Committee and member of African Union Smart Safety Surveillance (AU-3S) Joint Signal Management Group, aimed at facilitating cross-country signal management for COVID-19 vaccines in Africa, to support action in the interest of public health and safety.
She is the Head of Regulatory Compliance at the South African Health Products Regulatory Authority (SAHPRA). She’s a pharmacist with over 20 years of experience in various sectors of Pharmacy within South Africa from clinical, drug utilisation review, regulatory and policy making. Qualifications are B. Pharm, MSc in Pharmacy and MBA from the University of the Witwatersrand.
She manages the activities of market surveillance and control function of medicines and medical devices in terms of the Medicines and Related Substances Act, 101 of 1965. This includes control of import activities; market surveillance program for monitoring the quality of medical products throughout the supply chain prevention; detection of and response to substandard and falsified medical products; control of promotional, marketing and advertising activities.
Her duties also include managing activities relating to consumption and reporting consumption (manufacture, import, export, distribution, possession and use) of narcotics and psychotropic substances to UN’s International Narcotics Control Board (INCB) in terms of the Conventions requirements. This includes supervision of activities relating to licensing, medical and scientific cannabis and she also represents the organisation in this regard.
Additional roles includes leadership coaching: Wits MBA students and she’s an ad hoc external examiner and assessor of postgrad pharmaceutical education qualifications/programmes.
2006:Diplôme National en pharmacie
Faculté de Pharmacie de Monastir-Tunisie
2014:Diplôme National de Docteur en Pharmacie
Faculté de Pharmacie de Monastir. Tunisie
2017:Mastère Professionnel de Management de la qualité dans ledomaine de la Santé.
Faculté de Pharmacie de Monastir. Tunisie
2019-2020 : CEC Pharmaco-économie et Market Access :
Faculté de Pharmacie de Monastir. Tunisie
2021: Certificate: « Project management in Global health »
Certificate: « Leadership and management in health »
University of Washington-USA/Polygone Learning El Kram Tunisie
2022: Certificate: « Project Management in HIV »
University of Washington-USA/Polygone Learning El Kram Tunisie
2008-2013 : Officine Privée à la Marsa-Tunisie
Poste occupé : Pharmacien assistant
- Gestion d’une officine privée : (préparations officinales, dispensation des médicaments, gestion de stock, conseil en officine)
2013-Présent :Direction de la Pharmacie et du Médicament : Ministère de la Santé-Tunisie
Poste occupé : Pharmacien Principal de la santé Publique et chef de service de l’enregistrement des produits pharmaceutiques locaux
- Enregistrement des médicaments humains
- Coordination du plan d’action National de lutte contre la résistance aux antimicrobiens
He graduated from Doctor of Pharmacy (MCPHS University, USA).
After graduating he worked as a clinical pharmacist, owned, and ran a pharmacy, co-founded a Silicon Valley healthcare technology company, and ran a preventive healthcare company. Dr. Lucas is a co-patent holder for a neuropathic pain product. He is a certified pharmacogenetics/ pharmacogenomics pharmacist, Certified Immunization pharmacist since 2009, Certified Medication Therapy Management, among other.
His professional passions are:
- The provision, of Appropriate, Effective, Efficient and Safe pharmaceutical care…
- The recognition of the crucial and important role of pharmaceutical care to healthcare and economic productivity
- The reimbursement of cognitive pharmaceutical care services offered by pharmacist…
- The acknowledgement that Health Products and Technologies are pharmacist’s tools to achieve positive patient Outcome and as such we need to be heavily involved in ensuring quality…
- The capacity building of the pharmaceutical care service force
He serves as co-founder and Director at NewSpring Foundation that supports bright kids from Kibera. He is a Rotarian of the Rotary Club of Nairobi. His hobbies include Soccer Golf, Cycling, CrossFit and coaching his son soccer team.
External Medicine Dossier Assessor at Ethiopian Food and Drug Authority (EFDA) and
the Co-founder & Vice President of East Africa Regulatory Affairs Professionals Association (EARAPA). Mr. Nathan is also an assistant lecturer at the Addis Ababa University, School of Pharmacy, Department of Social Pharmacy and Pharmaceutics, Medicine Regulatory Affairs program.
He graduated from Clinical Pharmacy at the Addis Ababa University, and he’s currently finalizing his Master’s Degree in Medicine Regulatory Affairs.
I am an academician at the School of Pharmacy, in the Department of Pharmaceutics and Social Pharmacy.
Max Goldberg leads the global medical device reporting team for Worldwide Patient Safety at BMS. He holds a bachelors and master’s degree in engineering and has expertise in medical devices and combination products throughout the entire product lifecycle. Max has been involved in product development, risk management, manufacturing, and post market surveillance for medical devices, combination products, and biologics. He is involved in forming and implementing global combination product post market safety reporting regulation.
Drug Registration Officer at the Tanzania Medicines and Medical Devices Authority (TMDA)
I work as a Drug Registration Officer at the Tanzania Medicines and Medical Devices Authority (TMDA) where I am involved in the evaluation of medicinal products dossiers. Within TMDA, I have been the focal person for the SADC Medicines Regulatory Harmonization Programme (SADC MRH) for the past two years. Under the this Programme I have participated in many activities and initiatives to include co-chairing the SADC Variations Technical Working Group, and currently serving as a member to the current Technical Working Group (TWG) responsible for developing SADC Emergency Use Authorization Framework under the support of the German Federal Institute for Drugs and Medical Devices.
I am currently the Focal Person and the Regional Technical Officer for the East African Community Medicines Regulatory Harmonization Programme where I coordinate all matters related to EAC joint activities including assessment of dossiers and quality assurance of reports as well as a serving as a member of the Expert Working Group on Medicines Evaluation and Registration of the Programme.
She is an American board certified for pharmacotherapy specialty, she has two master degrees, one in clinical. pharmacotherapy and the second in public Administration from the American University in Cairo.
She is a fellow at the Egyptian board for healthcare management. She has profound working history in regulating pharmaceutical practices in the Egyptian public and private sectors, she used to be managing the PV General administration for more than 2 years, supporting the additionally, she represents the Egyptian drug authority as an Observer at the international cooperation on cosmetic regulations working group ICCR. Previously, she used to be the antimicrobial stewardship national coordinator and participated in the development of the National Action Plan for Antimicrobial Resistance.
Mr HONORE AYINKAMIYE is a Pharmacist with experience of more than 10 years in the pharmaceutical sector, both in private and public institutions, where he has been involved in technical and managerial positions. Currently, he is working with Rwanda Food and Drugs Authority (Rwanda FDA) as a Finished and Active Pharmaceutical Products Registration Specialist.
HONORE has been involved in different regulatory activities at the country level and he is also contributing to the Medicines Regulatory Harmonization initiatives as the assessor of product dossier applications at the East African Community (EAC) level to insure the products’ quality, safety and efficacy.
He is also the Focal Person for the WHO/SRA Collaborative Registration Procedures (CRP), a facilitated procedure that aims to accelerate the registration process through improved information sharing between WHO PQ and national regulatory authorities (NRAs).
HONORE is passionate about ensuring equitable access to safe, efficacious and quality health commodities.
Currently Executive Director of Zanzibar Food and Drug Agency (ZFDA). Over 20 years’ experience in strengthening Zanzibar Medicine Regulatory Authority from less resourced Pharmacy Board to the middle-income Food and Drug Agency.
He Participated in WHO assessment of Medicine Regulatory System in Sub Saharan African Countries, Devoted, Pioneering and Volunteering in Regional Medicine Regulatory Harmonization Initiatives and African Union Medicine, Policy and Regulation Reforms Expert Working Groups.
Dr. Peter Mbwiiri Ikamati is a Medicines Evaluation & Registration expert at Pharmacy and Poisons Board (PPB, Kenya) and EAC MRH programme (Assessment). He is the current Chief Principal Regulatory officer, Product Evaluation and Registration and has been overseeing all the PPB regulatory functions (on behalf of the Chief Executive Officer) towards achieving WHO Maturity Level 3 from May 2021. He has interest in research and has published work on analytical methods development and development of microspheric systems for drug delivery. Dr Mbwiiri additionally has interest in clinical trials regulations.
Dr. Mbwiiri earned his Bachelor of Pharmacy degree from the University of Nairobi in 2000. He holds a master’s degree in pharmaceutical sciences with Management Studies from the Kingston University in London and a doctorate in Health Sciences (Targeted drug delivery systems) from the Aston University, UK. He is an associate fellow of Higher Education (UK).
Dr. Mbwiiri started work at Ministry of Health as a Hospital Pharmacist and held various capacities upto the year 2005 when he joined the Pharmacy and Poisons Board (PPB; the National Medicines Regulatory Authority, Kenya). At Mbagathi district hospital, where he had risen to superintendent Pharmacist, he was part of the team that initiated piloting of HAART (Highly Active Anti-retroviral Therapy) programme that allowed for provision of antiretrovirals in public hospitals in Kenya.
Dr. Mbwiiri has a wealth of regulatory experience having served in various capacities within the Pharmacy and Poisons Board. He has been instrumental in initiating reforms on medicines evaluation and registration at the Pharmacy and Poisons Board (Kenya) and regionally (at East Africa Community (EAC) and Intergovernmental Authority on Development (IGAD).
Dr. Mbwiiri is also a consultant with World Health Organization Prequalification Team (formerly WHO Prequalification programme).
Farai joined the MCAZ in 2011 and has been involved in regulatory affairs for over 10 years.
He has been involved with the ZAZIBONA collaboration since its inception in 2013.
Farai has coordinated the ZAZIBONA dossier assessment activities since 2015.
A visionary entrepreneur and an industry captain, Dr. Amit N. Thakker, has been a ground-breaking pioneer in the integration of private sector within the healthcare system in Africa. Dr Thakker actively supports governments, corporates, health organizations and development partners to foster effective public private partnership initiatives towards improved health outcomes.
He is the executive chairman of Africa Health Business, a health consultancy, advisory and investment firm that aims to improve access to quality affordable healthcare in Africa. He is also the president of Africa Healthcare Federation, chairperson of the Kenya Health Professionals Oversight Authority, and the former chairman of Kenya Healthcare Federation.
He has served as a director at LumiraDx, Seven Seas Technology, AMREF Flying Doctors. Action Aid and Ghanima Limited. As an active member of several institutions including international business group YPO Gold (Nairobi Chapter), Dr. Thakker also chairs the University of Nairobi Alumni Medical Chapter and serves as an advisor to Asia Africa Investing & Consulting Ltd, Coalition for Blood in Africa (CoBA) and Ministry of Health, Kenya.
Dr. Thakker founded Avenue Healthcare, a Kenyan based integrated private health service provider in 1995 which lead him to receive the “Best Male Entrepreneur of the Year” award by Rotary International in 1999. He also won the “Best CEO” award by Titans Global in the Business and Professional services category in 2017 and proudly received the Chairman’s Award for Kenya Medical Association in 2004.
Lenias Hwenda is the Founder and CEO of Medicines for Africa, a social enterprise that improves access to treatment. She is a recognized influential thought leader and practitioner who continues to contribute at the highest stage of international health affairs working with African governments in the World Health Organization for more than a decade. She has participated in and led a number of intergovernmental and industry negotiations seeking the best solutions to meet the health needs of vulnerable people around the world. Lenias recently co-chaired the historic World Health Organization negotiations between governments on improving the transparency of markets for medicines, vaccines, and other health products during the World Health Assembly in 2019. She is a tireless advocate using her deep knowledge of public health, international affairs and health security to drive initiatives that improve access to healthcare by underserved communities. She hosts “Let´s Talk about health in Africa” Podcast conversations highlighting challenges and opportunities for improving the health of Africans.
Nevena Miletic is a Regulatory and Policy professional, passionate about bringing innovative therapeutic solutions to patients in need around the world.
She is a pharmacist, with postgraduate studies in Pharmacoeconomics, regulatory affairs and quality assurance, and a certified QP, with almost twenty years of experience in pharmaceutical industry.
Currently she works in the Global Regulatory Policy group in F. Hoffmann-La Roche, Switzerland, and for the last six years, she is chairing IFPMA Africa Regulatory Network and IFPMA CPP Network.
She is also a member of research-based pharmaceutical companies associations and boards (IFPMA Regulatory Science Committee, IFPMA Africa Engagement Committee, DIA Middle East & Africa Advisory Board, EFPIA ERAO, IATF etc.), involved in numerous meetings, workshops and projects with regulators, cross-industry and public-private collaborative platforms (e.g. Pre-ICDRA, ICDRA, SCoMRA, IMI/IHI etc.).
Ms. Miletic is strong advocate for regulatory convergence and harmonization, as well as for modernization of regulatory frameworks to enable innovative approaches in drug development and review.
She is a pharmacist by training. She has specialized in Pharmacoepidemiology and Pharmacovigilance, currently enrolled for PHD studies in Clinical Pharmacology and Pharmacovigilance at Karolinska Institutet in Sweden focusing on strengthening safety monitoring in public health programs with a focus on mass drug administration.
She is the Head of Pharmacovigilance at the Pharmacy and Poisons Board, Kenya, and the Vice President of International Society of Pharmacovigilance, Africa Chapter. She has 15 years working experience in Pharmacovigilance related work and is responsible for leading the PV team in Kenya to develop regulatory systems to strength Pharmacovigilance within the health sector and pharmaceutical industry.
She is a member of the Pharmacovigilance and PMS technical working groups in Kenya, within the East African Community and The Intergovernmental Authority on Development Regional Economic Blocks and has contributed to development of various tools and guidelines for strengthening of PV in the region. Recently appointed as a member of the AMRH Technical Committee on Regulatory Capacity Development in Africa (ToR RCD)
She is passionate about patient safety and keen on strengthening pharmacovigilance systems and patients’ contribution to safety monitoring of medical products and health technologies, she is also keen in contributing to a pool of trained PV specialists in Kenya and gives honorary lecturers to both undergraduate and masters students at University of Nairobi.
My current title is EMEA RA Lifecycle manager at Janssen. I am handling lifecycle management activities for the Pharma portfolio for countries in the Non-European Economic area region (includes Africa).
I have 10 years of Regulatory experience in different Regional/Global roles from 4 different pharma companies like Pfizer, GSK, Amgen and Janssen. I keep it brief, but please let me know if you want more details.
- Depuis 2017 : Pharmacienne de santé publique à la Direction de la Pharmacie et du Médicament (DPM) chargée de :
- La réception et l’évaluation des dossiers d’Autorisation de Mise sur le Marché (AMM)
- La participation aux travaux des commissions spécialisées (Neurologie, Psychiatrie, Ophtalmologie, Dermatologie, …) et la Commission d’Achat des Médicaments (CAM) à la Pharmacie Centrale de Tunisie (PCT).
- La validation des bons de commandes fermes (ATU)
- Suivi de la pénurie des médicaments
- 2013-2017: Pharmacienne assistante en officine privée.
- Octobre 2012-Septembre 2017: Pharmacienne formatrice à l’Institut Tunisien de Santé
- 2012: Préparation de thèse de doctorat en Pharmacie (Recherche à l’Institut Pasteur de Tunis : Laboratoire Parasitologie et Immunologie)
- Septembre -Novembre 2011 : Stage officinal au sein d’une Officine privée « Pharmacie Hattab Naouar Nouvelle Médina»: Dispensation de médicaments, Conseils, Préparations officinales, Préparations magistrales, Gestion officinale…
- Décembre- Février 2012 : Stage en biologie clinique au sein de laboratoire de Biochimie et de Toxicologie de Centre Hospitalo-Universitaire la Rabta Tunis
- Septembre 2009 – Février 2010 :
- Stage de 1 mois en Pharmacie hospitalière à l’EPS Aziza Othmana Tunis: pharmacie interne, pharmacie externe, préparatoire, dépôt des médicaments et dépôt des dispositifs médicaux.
- Stage de 5 mois d’Initiation à la Pharmacie clinique au Centre Hospitalo- à l’EPS Aziza Othmana Tunis: Service hématologie.
- Juin- Juillet 2005 :
- Stage d’Initiation aux soins infirmiers au service de maternité/Gynécologie de l’Hôpital Régional de
- Stage au sein de la pharmacie de l’Hôpital Régional de
- Juin 2004 : Stage d’Initiation à la pratique officinale au sein d’une Officine privée « Pharmacie Hattab Naouar Nouvelle Médina»: Dispensation de médicaments, Conseils, Préparations officinales, Préparations magistrales, Gestion officinale…
- Maîtrise des Préparations hospitalières et officinales.
- Maîtrise des Préparations Magistrales.
- Maîtrise des logiciels de bureautique : Word, Excel, Power Point …
- Permis de conduire
- Français : lu, écrit et parlé
- Anglais : lu, écrit et parlé
- Arabe : langue maternelle
- Allemand : lu et écrit
Pr Nadjat LOUMI-MEDEDJEL, Director of the Centre National de Pharmacovigilance et de Materiovigilance (CNPM), is a doctor graduated from the University of Algiers, holding a Diploma of Advanced Studies from the Faculty of Medicine of Paris (France), a university degree in pharmacovigilance from the university Claude Bernard of Lyon and a doctoral thesis in clinical pharmacology at the Faculty of Medicine of Besançon (France).
She took part in the creation of the CNPM with its founder Professor A Helali in 1998, whereshe has always been devoted to pharmacovigilance and materiovigilance.
Since 2016, she has introduced the concept of Phytovigilance, Réactovigilance, Cosmetovigilance, in addition to the vigilance of the drug, the medicaldevice and the vaccine alreadyestablished.
Teacherat the Faculty of Medicine of Algiers, wheresheteaches the module of pharmacology. She supervises the training of resident physicians in clinical pharmacology.
She supervises also the training of health professional in :
“Pharmacovigilance and Materiovigilance” ; “Medical good prescribing” ; “Monitoring plasmatic of medicine” ; “Rational drug use program”.
She is Editor of the independent Medical journal “la Revue Prescrire” since 2007.
Kate Kikule is the Principal Technical Advisor for the pharmaceutical regulatory systems portfolio under the Medicines, Technologies and Pharmaceutical Services (MTaPS) initiative of the Medicines Sciences for Health (MSH), with expertise in regulation of medicines and health technologies. Kikule supports country programs by providing technical assistance to strengthen medicine regulatory functions, including medicine registration, regulatory inspections, licensing of premises, market surveillance, and pharmacovigilance. She also provides technical guidance for the development and implementation of policies, regulations, guidelines, and tools for strong and effective pharmaceutical regulatory systems. She is an experienced public health professional and pharmacist with more 20 years of experience in medicine regulation in emerging and low- and middle-income countries across Africa, Asia, and Europe. Kikule holds a Bachelor of Pharmacy (Hons) from the University of Dar-es- Salaam, United Republic of Tanzania, and an MPH specializing in health economics from the University of Capetown, South Africa.
George is a pharmacist by profession and had a Master degree in Public Health from the University of Ghana and a certificate in Pharmacovigilance and Pharmacoepidemiology from London School of Hygiene and Tropical Medicine. He is currently a PhD candidate at the University of Groningen where his thesis is focused on patients’ contribution to pharmacovigilance in Sub-Saharan Africa.
He is a Chief Regulatory Officer and the Head of the Safety Monitoring Department at the Food and Drugs Authority.
He has authored several abstracts and original research articles on medicine safety in peer reviewed journals.
George’s interest is in strengthening pharmacovigilance systems and patients’ contribution to safety monitoring of medicines and other health products.
Santosh Balbhadra Trivedi has a Bachelor of Engineering (Chemical) degree from G H Patel College of Engineering and Technology, Vallabh Vidyanagar, Gujarat, India, where he studied from 1998 to 2002. He has almost 20 years of overall experience and has worked in the Pharma & Life Sciences industry vertical for over 12 years in various roles from a Developer to Business Analyst, Product Owner, Serialization and Track & Trace expert, etc.
His current role since Feb-2022 is with Honeywell as the Senior Product Manager – Track & Trace facilitating governments/customers implementing Serialization and Track & Trace solutions to adhere to/implement the legal regulation requirements and/or to implement the value added solutions to improvise the supply chain visibility and integrity.
Brève présentation : Pharmacien, marié et père de trois enfants. J’ai treize (15) ans d’expérience professionnelle dont dix (10) ans dans le domaine de la réglementation et de la régulation pharmaceutique. Je suis dans l’amélioration continue du travail et j’ai une bonne capacité d’adaptation. Mes objectifs professionnels : Acquerir une excellente compétence dans la régulation pharmaceutique et Partager ces connaissances acquises en tant qu’expert.
Ashifi founded Sproxil® in 2009 and currently serves as the company’s Chief Executive Officer. Under his leadership, Sproxil developed its award-winning solutions that have been used on over 2.5 billion product units available to consumers in 6 countries to verify the authenticity of their products and earn instant rewards for their loyalty.
In 2015, Ashifi was named to Fortune’s 40 under 40 list. He was awarded the Social Entrepreneur of the Year award in 2014 by the Schwab Foundation and joined the Fast Company Most Creative People in Business 1000 community. In 2013, Sproxil was named the world’s most innovative company in health care by Fast Company, and #7 most innovative worldwide, beating 99 of the Fortune 100 companies. Most recently, he has been picked as a finalist for the 2020 Global Business Hall of Fame presented by JA Worldwide.
Ashifi served on the World Economic Forum’s Global Agenda Council on Social Innovation and on the Meta-Council on the Illicit Economy. He holds a US Patent and earned a Ph.D. in Engineering from Dartmouth College, where he delivered the 2020 alumni remarks at Investiture. Ashifi holds a B.A. in Mathematics and Physics from Whitman College. He was Whitman’s 2018 commencement speaker and received an honorary doctorate. He is Dartmouth’s first-ever Ph.D. Innovation Fellow and teaches an executive seminar and a course in New Business Ventures Technology Management at Columbia University.
Ashifi volunteers for the Whitman College President’s Advisory Board and the Board of Advisors at Dartmouth’s Thayer School of Engineering.
Dr. Amira Amin received her Bachelor degree of pharmaceutical science. faculty of pharmacy, Cairo University in 2006 and Diploma in clinical pharmacy from faculty of pharmacy (Ain-Shams university) in 2010.
Today she is the deputy head of Egyptian pharmaceutical vigilance administration at Egyptian Drug Authority since September 2020 and joined from pharmacovigilance specialist at Egyptian pharmacovigilance center (EPVC) – (CAPA) – Ministry of health (MOH) where she honed her skills for 6 years.
Tshepiso has assumed a role of a Clinical Operations Manager within one of the rapidly growing CRO organizations, Tigermed. She has prior experience as Head of Clinical Monitoring at one of the leading pharmaceutical companies, GSK.
Previously gained experience as a Local Study Manager, CRA, Study Coordinator.
In her recent clinical research journey and different roles, she gained experience in providing leadership, cultivating good relationships with internal and external stakeholders. Tshepiso is committed in delivering what is expected of her with integrity: by being dependable, accountable, with primary focus on doing what is right and of high quality.
Greg Perry joined IFPMA on 1st February 2018 and has responsibility for IFPMA’s external outreach and stakeholder engagement in global health topics including innovation, access, and the international regulatory environment. Greg Perry brought with him more than 20 years’ leadership and advocacy experience in the public healthcare arena.
Prior to joining IFPMA, Greg worked as Executive Director of the Medicines Patent Pool, which he joined in 2013 and as Director General of the European Generic Medicines Association (1999 – 2013) in Brussels. Previously he worked as a partner in a UK public affairs company as a European Union policy advisor to corporate and non-governmental organizations, and before that as a Parliamentary Advisor to Members of the European Parliament. Greg is a Member of the Advisory Council of the Organization for Professionals in Regulatory Affairs (TOPRA) and is a former member of the Standing Advisory Committee before the European Patent Office (SACEPO). Greg also holds the Golden Cross of Merit of the Republic of Poland.
Inas is a holder of Pharmacy diploma, and Master in EU and International Regulations and Healthcare Laws from Paris V University. Inas has 18 years expertise in the European and Emergent markets regulations; she worked for various MNCs, and currently she is heading the Regulatory and Policy departments for MEA region in Novartis.
Her focus and interest are the Healthcare reforms and legislations, policy shaping with main objective to accelerate patient access to innovative medicines.
Inas chaired the EFPIA regulatory group for 3 years; And she chaired the PhRMA association regulatory group for 4 years. She also chaired the program committee for the Middle East regulatory conference in 2019, and actively participating as a speaker in regional and international conferences.
He has more than 7 years of consulting experience within a variety of industries including, Financial Services, Energy and Resources and Life Sciences and Health Care. Prior to joining Deloitte, Mitesh gained 4 years of clinical experience as a Physiotherapist. His recent focus areas have been Data Strategy, Data Management, Data Privacy and Insights Driven Organisation.
Sisay Endale Biru is an academician and researcher at Addis Ababa University, College of Health Sciences, School of Pharmacy, Ethiopia. He completed his Bachelor of Pharmacy from Addis Ababa University and Master of Sciences in Regulatory Affairs (Medicine Regulation Track) from the same university.
He also graduated from Admas University with a bachelor’s degree in Marketing Management. He is currently engaged in research, teaching, and advising. He is the coordinator of Pharmacovigilance (PV) at the Tikur Anbessa Specialized Hospital’s PV center in Addis Ababa, Ethiopia. He works with the Ethiopian Pharmaceutical Association as a trainer, PV course lead, and CPD course evaluator.
Additionally, he actively contributes to the development of policy, research, the development of PV training materials, and the assessment of medication dossiers for the Ethiopian Food and Drug Authority (EFDA). His research interests include health and drug policy analysis, drug regulation, and drug safety (PV).
Lebogang has over 11 years of working experience in the Pharmaceutical Industry, a fully registered Pharmacist with the Botswana Health Professions Council graduated with a Bachelor of Pharmacy from the Latrobe University, Bendigo Australia.
A Pharmacovigilance and Clinical trials Manager with the Botswana Medicines Regulatory Authority (BoMRA), Lebogang has a firm grip in the Drug Regulatory systems, Market dynamics and Pharmaceutical industry, currently responsible for core PV operational functions including Case Management, and Quality and Document Management, managing the operation infrastructure required to oversee all aspects of adverse event collection, processing, and reporting from clinical trials.
Doubling as the President of The Pharmaceutical Society of Botswana, Lebogang is involved in the development of Campaigns that promote health care industry and has gone to develop strategic relations and collaborations with stakeholders within the health industry in Botswana and the SADC region. A member of the Commonwealth Pharmacist Association Council, his role includes but not limited to advocating for collaboration and partnership amongst the Commonwealth Pharmacy Associations. A member of the joint taskforce for the Ministry of Health & Wellness and Business Botswana mandated with developing strategic projects that will see private sector collaboration in public healthcare delivery. Also, member of International Society of Pharmacovigilance
LK as he is affectionally known prides himself with the development of safety exchange agreements with license partners and distributors in support of PV collaborations, a firm believer that accomplishments validate facts you already know while setbacks teach the hard lessons.
Yusuf Dawood is the Country Safety head for SANOFI South Africa. He is also the vice chair of IPASA PV
WorkStream. His areas of expertise include Implementation and management of Pharmacovigilance
system including Patient support programs, Market research programs and Digital projects, Safety
Agreements, Risk Management and case management. He has collaborated on projects such as Global
Reconciliation Working Group, Pharmacovigilance education and internal pharmacovigilance campaigns.
He completed his Master of Pharmacy – with distinction at the University of the Witwatersrand. To
further enhance his management skills, he completed Project Management at the Gordon Institute of
Business sciences. Yusuf strives for excellence with his strategic thinking, simplification of processes and
his creative, innovative and inquisitive charms.
Head of the executive team for the Egyptian Pharmaceutical Track & Trace System
Project, being responsible for project management & implementing the
Traceability National Platform for the Pharmaceutical Products for securing against
Substandard, Spurious, Falsely Labeled, Falsified & Counterfeit (SSFFC) products,
securing drugs supply chain around Egypt, ensuring market authorization, and
enhancing market monitoring and control. Being the Deputy Head of the Digital
Transformation Dept. a specialized unit that is responsible for the Digital
Transformation inside the Egyptian Drug Authority. He was also a team member in
the Egyptian Pharmaceutical Supply Chain Reform Project; that is electronically
secures & monitors the availability of all pharmaceutical products all over the
governmental healthcare sector. He is a certified Healthcare Informatician since
2015 (Egyptian Fellowship Board, 2015). For 5 years, he was the Head of
Pharmaceutical Regional Warehouses for Injectable, Emergency & Narcotic
Christine Oyewo is responsible for the implementation of GS1 Standards and Traceability in the
Nigerian Healthcare delivery system and pharmaceutical sector.
Christine is a pharmacist with an MBA and several Supply Chain Certifications including from MIT. She spent part of her career in the pharmaceutical industry and worked in sales and marketing as well as in regulatory affairs. She has great passion for technologies around efficiency and visibility in the supply chain and its positive impact on patient safety and in the fight against substandard and fake medications.
She strongly believes that collaboration among all stakeholders will make this possible in Africa.
As the pioneer of successfully setting up and running Kenya’s first fully approved and regulated Online Pharmacy, Dr. Farzana Sunderji has forged her reputation as an exceptional, forward-thinking Pharmacist by leveraging on technology within the digital era.
Leaving a lucrative career in the UK to come back home to Kenya, Dr. Farzana Sunderji has made it her mission to use her skillset conscientiously and consciously towards improving the pharmaceutical industry in whatever capacity she can, both locally as well as internationally.
She has been recognised for her EQ in every project she has so far undertaken and has proven herself time and again to be a born leader who is able to clearly articulate goals, anticipate where the industry is heading and ensure that she is well up to date with current trends and practices, all the while remaining extremely conscious of Best Practice, Due Diligence and her own set of Ethical and Moral standards.
Every career decision she has made has been backed by the ethos of an exceptionally high standard of care to patients, and to put a patient’s health above financial compensation. Her recommendations on improving how companies operate have yielded phenomenal results and won her deep respect not only among peers but also among end consumers who have commended the changes.
Tshepiso Mabena has a Degree in Nursing ( B CUR), B Tech Biopharmaceutical Sciences and a Certificate in Project Management.
She started her career at Investigator Sites as a study Coordinator and progressed through global CROs and international Pharma Companies: Novartis Vaccines, IQVIA, ClinTect International (contracted to MSD), and GSK.
With 16 years in clinical research experience overseeing all project phases – monitoring, site feasibility, selection, regulatory submissions, budget negotiations, contract management, start-up and Third-Party Oversight, Tshepiso Mabena joined Tigermed in May 2021 within Therapeutic Area of Oncology, Respiratory, Infectious Diseases, Women’s Health and Vaccines.
Tshepiso Mabena focus is to cultivate good relationships with internal and external stakeholders.
Winnie Munene is the Patient Safety and Pharmacovigilance Manager, Boehringer Ingelheim. She is majorly responsible for English speaking Sub-Sahara African countries. Winnie holds a Bachelor of Pharmacy from University of Nairobi, an MBA in Healthcare Management from Strathmore Business School and higher diploma in Industrial Pharmaceutical Advanced Training from Purdue University/Kilimanjaro School of Pharmacy. She is an Afrika Kommt fellow 2017 having worked at Merck KGaA in their Germany headquarters for an year.
Winnie is a conscientious healthcare professional passionate about healthcare access and social equity all in the sphere of corporate governance and ethical business practice. She has close to 15 years in both management and leadership roles in Pharmacovilance, Quality and Regulatory Affairs with cross-functional management responsibilities for healthcare access programs and projects. She has a good understanding and vast experience of local and global regulations & guidelines.
Winnie is focused on building her expertise in pharmacovigilance and patient safety management, medical and pharmaceutical compliance, new drug registration for go-to market strategies, regulatory, quality assurance management, which are paramount for access to medicines for developing countries.
Her ultimate career goal is to be a thought leader in healthcare access projects and programs, driving and managing projects that are geared towards medicine and medical technologies access & availability while supporting go-to-market strategies.
She is also a mother to a 10 year old strong-willed lovely girl.
Since July 2003, Emeka has been playing active role in the West African Food, Drugs,Cosmetics and Medical Devices Regulatory Affairs Ecosystem. His experience cuts across the Nigerian Food and Drug Authority (NAFDAC) as Regulator (cGMP Inspector) and
Industry as a Regulatory Affairs Manager. As a Regulatory Affairs Manger he exceptionally, influenced, navigated and interpreted regulations for businesses in Nigeria and other West African markets.
Emeka’s focus is in simplifying regulatory complexities in West African countries for business growth by creatively interpreting and influencing regulations; bridging knowledge gaps and relationship building between Regulators and the industry. He understands the
thinking of regulatory authorities and the regulatory challenges facing businesses in West African markets.
Currently he leads the Regulatory Affairs Projects Team at CQRAFF Solutions Ltd – a company incorporated by law in Nigeria to render Corporate Regulatory Affairs services to Cosmetics, Pharmaceuticals, Medical Devices & Diagnostics, Food & Nutraceuticals
companies with strong presence in Nigeria and Ghana. In his current role he advises clients on: Strategic Regulatory Consulting for Market access / entry. Regulatory Submissions and Intelligence, Marketing Authorization applications and Post Marketing maintenance, Product Registration and License Management, Site cGMP Inspection Readiness, regulatory audit support services for manufacturing facilities and any other regulatory activity that may arise.
Emeka holds who holds a B.Sc Hons Degree in Applied Microbiology is a senior member of American Society of Quality (ASQ) and a member of the Regulatory Affairs Professional Society (RAPS).
Nuran Idris joined GS1 Global Office in January 2020. She works in the Healthcare team as Healthcare manager for Africa. She is based in Nairobi, Kenya and is originally from neighboring Tanzania.
Nuran’s main role at GS1 is to support countries in Africa in establishing pharmaceutical traceability systems using GS1 standards.
Prior to joining GS1, she worked for multiple USAID funded projects in Tanzania and Malawi with short term engagements in Zambia and Ivory Coast. Nuran also briefly worked for one of Global Fund’s project in The Netherlands.
Nuran’s experiences have seen her engage multiple stakeholders from the grass root level up to senior levels in local and international settings. From the digital health angle, Nuran has conducted trainings and managed teams that deployed systems that have contributed positively to improvements in local supply chain operations.
With the power of standards, Nuran strongly believes that even more efficiencies and mostly, improved care to patients can be achieved in developing countries.
Nuran is a Political Scientist and a global eHealth specialist by training.
I am a pharmaceutical professional pharmacist; with about 17 years’ experience in Registration & Quality fields, including CTD, NeeS & e-CTD, registration & launching/market access of pharmaceutical products/Cosmetics/MD/OTC/GSL/specialties in diversified regions (MENA, Levant, CIS, African Countries, Gulf Region, Asian Countries (ACTD), APAC & WHO dossiers) according to the guidance of each country.
I am dealing with awareness with WHO, ICH, FDA, Eudralex, EMEA, OMCL & ISO 17025 guidelines through real inspection audits from WHO, FDA, EMEA, DNDI, ISO 17025 & others. In addition, I performed GMP audits for API (ICH Q7 guideline) & Packaging manufacturers in China, India & Malaysia; and pre-inspection visits for pharmaceutical finished products companies in UK.
I am MBA holder; Certified Six Sigma Green belt (CSSGB) by IQF/USA and passing courses of Total Quality Management (TQM-P) and PMP (PMBOK V.5). I deliver training courses for Regulatory Affairs & Quality fields.
Currently I am the Regulatory Affairs Lead in Acino, based in Cairo Egypt, managing Gulf Eastern
Mediterranean (GEM) Region including 7 Countries (UAE, Kuwait, Bahrain, Oman, Qatar, Jordan,
Lebanon) and a team of 3.
I have more than 15 years experience in Regulatory Affairs in different region; GCC, Middle East, & North
I started my career in 2002 in Manufacturing Quality Assurance & Validation.
Then I have shifted to Regulatory Affairs since 2006 & I have been working among many local &
multinational companies such as Novartis & Pfizer until joining Acino in 2019.
“Heba Nabil is Regulatory Affairs Senior Manager for Egypt and Sudan- Pfizer Biopharmaceuticals Egypt.
She graduated in the Faculty of Pharmacy Cairo University then started her career in the academic field as a teaching assistant up to senior supervisor in Pharmaceutical technology department, Faculty of Pharmacy, Misr International University (MIU).
After that she moved to the regulatory affairs field when she joined the Registration General Directorate in the Central Administration for Pharmaceutical Affairs(CAPA), Ministry of Health and Population of Egypt. she worked as the Rapporteur of The Technical Committee for Drug Control then she became the Head of Human Pharmaceutical Drug products Registration Directorate before moving to her current position.”
Dr. Anwar is a professional business partner, with strong scientific & medical background, brings up 20 years of experience in the pharmaceutical industry.
Dr. Anwar obtained a bachelor’s degree in veterinary medicine and post graduate Microbiology diploma focusing on Immunology, Bacteriology, Virology and Mycology from Cairo University, Egypt.
Dr. Anwar started the career in 2001 as a medical representative in Egypt and then relocated to UAE in 2007, where she held several seniors roles in different top multinational pharmaceutical companies,” Novartis, GSK, Allergan and Abbvie”.
Dr. Anwar accomplished high level of business acumen with diversified roles in Medical affairs, clinical trials and Pharmacovigilance, within diversified geographical areas
Alex Juma Ismail, a pharmacist by profession currently working with the Tanzania Medicines and Medical Devices Authority (TMDA) within the Directorate of Medical Products Control under the section of Medicines Registration.
Within TMDA, he works as an assessor of quality, safety and efficacy of medicines and other medical products in the capacity of a Drug Registration Officer since 2017 and is serving as the focal person for the Southern African Development Community Medicines Regulatory Harmonization Programme (SADC-MRH) specifically the assessments unit and currently co-chairing the SADC Variations Technical Working Group.
PhArmacoVigilance Africa (PAVIA) coordinator- Eswatini. Alemayehu holds a bachelor’s degree in Pharmacy, a master’s degree in clinical research and currently pursuing his Ph.D. in pharmacovigilance and pharmacoepidemiology at the University of Bordeaux, France.
Rajappen is a Pharmacist, registered with the South African Pharmacy
Council, and has over two decades of extensive pharmaceutical
knowledge and experience in regulatory affairs, corporate affairs and
quality management practices. Kacy is a senior pharmaceutical
executive who is focussed, pragmatic, passionate and results driven.
Since 2007, Rajappen has been a Co-Founder and Director in KD
Consulting Pharmaceutical Solutions (KDC), a consultancy practice
supporting the needs of pharmaceutical, medical device, veterinary and
allied health companies in successfully delivering new products to markets and maintaining products inmarket. With her proven experience and track record within the industry, Rajappen has assisted companies
in developing filing strategies to facilitate registration of products in South Africa and Sub-Saharan Africa.
Rajappen’s intimate involvement within the pharmaceutical industry has allowed her to stay abreast of the
rapidly transitioning health care environment and strategically advise clients accordingly.
Since 2009, Rajappen is the Co-founder and Director of Umsebe Healthcare, a licensed South African
pharmaceutical company whose focus is on addressing the unmet medical needs of South African patients.
Rajappen is responsible and accountable for maintaining compliance of the Company’s product portfolio
and pipe line products, and ensuring quick access to market. Leading the company’s mid-long term plans
and strategy is top priority. Rajappen is also responsible for recruitment and developing the team to enable
high performance across all functions. With a vested interest in flattening the curve with the recent COVID19 pandemic, the company has collaborated with Thinking Crystal (Pty) Ltd, for the supply and distribution
of critical products required to manage the COVID-19 crisis.
Rajappen previously held the positions of Regulatory Affairs Departmental Manager and Medical Marketing
Manager at 3M Pharmaceuticals SA (Pty) Ltd (later known as iNova Pharmaceuticals). Rajappen was
responsible for ensuring the smooth, ethical functioning of the company by providing support for the
Marketing Department on Regulatory / Medical Strategic development, providing medical support to meet
business objective, participated in cross functional activities within the Division and responsible for
communicating and modelling management goals and values to assigned personnel. Rajappen also held the
position of Regulatory Affairs Pharmacist at Cipla-Medpro.
Some of the services that Rajappen is involved with across South Africa and Sub-Saharan Africa includes
amongst others: Regulatory consulting including Regulatory strategy development, Regulatory portfolio
management, Regulatory-Quality business management, Product registration and Registerability
Rajappen is registered with the South African Pharmacy Council, Pharmaceutical Society of South Africa and
the South African Pharmaceutical Regulatory Affairs Association and is a member of the Regulatory
Committee of the South African Medical Device Association (SAMED) and well as IPASA (Innovative
Pharmaceutical Association South Africa). KDC is registered with and is a member of the Heath Products
Experienced with a demonstrated history of working in the Pharmaceuticals & Medical devices industry. Skilled in Marketing Management, Business Planning, Sales, Market Research, and Management. Strong business development professional.
Poste actuel : Point Focal National de la Pharmacovigilance par décision N°723 MSHP-Centre National d’Appui à la lutte contre la Maladie du 09/09/2015, chargé de :
Recueillir et diffuser les informations sur les effets indésirables des médicaments
Analyser et évaluer le lien entre les produits de santé et les effets indésirables par l’imputabilité ;
Coordonner les activités de notifications au sein des structures et programmes de santé ;
Collecter les notifications d’effets indésirables des produits de santé provenant des professionnels de santé des secteurs public et privé des programmes de santé et de l’industrie pharmaceutique ;
Documenter et archiver les informations sur les effets indésirables des produits de santé dans une banque de santé ;
Faire le suivi et la retro information aux notifications des effets indésirables des produits de santé ;
Répondre aux demandes sur les effets indésirables des médicaments
Assurer les échanges avec le centre international de pharmacovigilance de l’OMS : UMC (Uppsala Monitoring center) ;
Programmer et réaliser des enquêtes de pharmacovigilance ;
Générer les signaux et alertes en matière de pharmacovigilance ;
Participation à la 24 ème session ordinaire du conseil d’administration du Centre National d’ Appui à la lutte contre la Maladie (CNAM) ;
Mission de supervision des activités du deuxième passage de la campagne de Chimio prévention du Paludisme Saisonnier chez les enfants de 3 à 59 mois dans le district sanitaire de Sélingue du 01-07 septembre 2016;
Mission de supervision formative de pharmacovigilance dans les districts sanitaires de Djenne et Bandiagara, Région de Mopti du 20 au 29 Novembre 2016.
Head of Regulatory Affairs – MENA in Hikma Pharmaceuticals (Amman – Jordan):
BSc in Pharmacy from Jordan University, 1991
MSc in drug analysis from Monastir University, Tunisia, 1998
PhD in Pharmaceutical sciences from University of Lille II, France, 2005. PhD thesis was awarded with distinction and it was nominated for “State Prize” at the Pharmaceutical Academy in Paris.
I have been working in the pharmaceutical industry for around 30 years. Joined Hikma Pharmaceuticals in 1991 and worked in different technical departments, with many years of hands-on experience in the formulation and process development, as well as analytical development of oral and injectable generic products. I held the position of Technical Director in Medicef (a newly established sister company for Hikma in Tunisia) for seven years, where I established all the technical departments: QA, QC, Product Pipeline, technical transfer and Regulatory Affairs. I also headed the Research and Development – Injectables department in Amman for around 10 years and successfully developed and registered new generic products targeting global markets in USA, EU and MENA.
Currently, I am heading the Regulatory Affairs activities in the MENA region, contributing to the development of the Regulatory strategy as well as setting the required implementation plans and programs that ensure effective and efficient function’s performance to best serve business needs across the region; while overseeing the Regulatory Affairs operations considering compliance with the internal and external policies and legislations, including submissions of new products in the pipeline and the maintenance of the existing portfolio in more than 16 countries in the MENA region, with local regulatory affairs teams in the majority of these countries. Work closely with health authorities and work on shaping the regulatory environment through liaising with the local agencies, local pharmaceutical organizations and associations and other stakeholders.
Other Activities in the Educational Field:
Jordan University of Science and Technology-Deanship of Scientific Research:
- Member in the “Scientific Research Committee” during the scholar year 2019-2020.
- Member in the Faculty of Pharmacy board during the scholar year 2018 – 2019.
Jordan University of Science and Technology (JUST) & Yarmouk University:
- Deliver lectures to 5th year Pharmacy students on the application of certain concepts and technologies in the pharmaceutical industry, focusing on bridging the gap between theorical knowledge and practical application (started in 2017 till now).
Jordanian Association for Pharmacists:
Received an appreciation and recognition award from the “Jordanian Association for Pharmacists” for the significant contribution to the development of pharmaceutical industry in Jordan (March 2019).
Qutaiba Al Manaseer, is a Public affairs professional drawing on more than 15 years’ experience in the biopharmaceutical industry. He is the Government Affairs Director for the Middle East and Africa, and he is leading the COVID vaccine supply project in AstraZeneca in this region.
Qutaiba serves in the Emirates Health Economics Society board as the Media and Public Relations Chairman.
Qutaiba holds an MBA from the Swiss Business School, Switzerland and a bachelor’s degree in Pharmacy from the University of Jordan. He is completing a master’s in health economics from Barcelona School of Management.
Before joining AZ, Qutaiba was the strategic market access and pricing lead for GSK Gulf.
Qutaiba is a strong advocate for Diversity and Inclusion, and he was the Global Development Lead in the Executive committee of the Women Leadership Initiative in GSK.
Dr. Mona Al Moussli pursued her pharmacy studies. Holder of a Bachelor degree from Dubai pharmacy college 2002 and MBA from Preston university, in 2018 she has received her International Regulatory Affairs master degree from KREMS university – Vienna. She is the first initiator of regulatory affairs course in the gulf region, working closely with Dubai pharmacy college.
A Co-founder and Managing Director of PRA Consultancy which is the First Pharma Consultancy in UAE and she is an astute professional with over 15 years of hands on experience in the Regulatory Affair field for pharmaceuticals, Retail Pharmacies and Hospital Pharmacies, Dr. Al Moussli have been entrusted with international brands across the GCC and Middle East. Together with her PRA team she continuously delivers high quality standards to meet the fast paced, high turn-over industry. Regulatory conferences and trainings are among the many other activities she manages and she is working on pushing the health care products Regulations in 2021 to new levels.
Eman has a wealth of experience in PV since 2012; with a strong network with decision makers in different health authorities. She held several senior roles in multiple multinational Pharma companies.
She started her PV career in Cairo, in 2012, at the very early beginnings of the Egyptian PV guidelines followed by the Arab GVP implementation in 2015.
She has worked in multiple pharmaceutical companies, from local Egyptian companies to Gilead’s agent in Cairo then joined Allergan as Egypt LSO in March 2016. After one year, she was selected to be the Regional PV Lead for TMEA region in March 2017 and relocated to Dubai in Dec 2017.
She also has a vast experience in delivering trainings to multiple pharmaceutical companies in Egypt on Arab GVP and her trainings were accredited and acknowledged by the Head of Egyptian Pharmaceutical Vigilance Center in Egypt.
Diplômé en Médecine, le Professeur Riadh DAGHFOUS a reçu le titre de Médecin Résident Etranger des Hôpitaux de Paris et une Maitrise en Sciences biologiques en 1990, et a obtenu sa spécialité en Pharmacologie à l’Université de Tunis durant la même année et un Certificat d’études supérieures en statistique et épidémiologie en1995. Il a été nommé Assistant Hospitalo-Universitaire en Pharmacologie à la Faculté de Médecine de Tunis en 1991 puis Maître de Conférence Agrégé Hospitalo-Universitaire en 1996 et enfin Professeur Hospitalo-Universitaire en 2004.
Il a occupé plusieurs postes de responsabilité dont le poste de coordinateur de l’enseignement de la Pharmacologie à la Faculté de Médecine de Tunis (de 2002 à 2008) et chef de service de recueil et analyse des effets indésirables au Centre National de Pharmacovigilance (de 2007 à 2016) et a occupé la place de représentant tunisien auprès de l’OMS pour le réseau international de surveillance des vaccins pré-qualifiés.
Il est depuis Janvier 2017, Directeur Général Centre National du Pharmacovigilance.
le Professeur Riadh DAGHFOUS est président fondateur de la société tunisienne de pharmacovigilance, membre fondateur de l’African society of pharmacovigilance et membre de l’International society of pharmacovigilance.
I graduated from Clinical Pharmacy at the Addis Ababa University. I am currently finalizing my Master’s degree in Medicine Regulatory Affairs. I am an academcian at the School of Pharmacy, in the Department of Pharmaceutics and Social Pharmacy. I am the Co founder and Vice President of East Africa Regulatory Affairs Professionals Association. I work closely with the Ethiopian Food and Drug Authority (EFDA) in the medicine registration, inspection and PR departments. I also work as an external regulatory consultant for medicine registration.
Biography – Dr. Ahmed Hegazy
Dr. Ahmed Hegazy is a Physician by education and holds a Master’s degree in Pharmaceutical Medicine
(First Class Honor), Mini MBA, Medical Quality Management Diploma and Hospital Management Diploma.
- He holds certificates on programs or courses from:
- The George Washington University, USA
- Columbia University, USA
- Royal College of Physicians, UK
- Hibernia College, Ireland
- Uppsala Monitoring Center, WHO
- He attended many trainings in leadership, strategic thinking, decision-making, brand planning, building efficient teams, high performance, accountability, communication skills, and persuasion and selling skills.
- Moreover, He attended courses in Outcome Research and Health Economics, Drug discovery and development, Medical Ethics, Biostatistics, Research Methodology, Regulatory Affairs, Medical Affairs, and Pharmacovigilance.
- Dr. Ahmed had been trained on ISO 9001-2015 Quality Lead Auditor Certification and Lean and Six Sigma Greenbelt Holder.
Dr. Ahmed received various awards and recognitions in innovation (Upjohn Award), achievements and others.
- He has scientific publications in international journals.
- Advisory Board, Committee member or member to International Scientific Journals, Associations and Conferences.
- He is a member of Emirates Medical Association
- He is a member of Emirates Health Economics Society
- He is a member of the ISoP society and was a committee member of the ISoP Middle East Chapter.
- He was invited as a speaker for hundreds of local, regional, international events and on TV as well as various online programs.
- He attended numerous (~100s) conferences and events.
He owns more than 25 years of wealthy experience in Pharmaceutical Industry in different regions and
functions (sales, training, medical, marketing and PV).
- He is an Expert in the Medical Affairs as he worked for 11 years in various positions in the Medical Affairs (Sr. Manager, Regional Manager and Head) in which he got experience in all MA roles, clinical research, governance, compliance, quality. He possesses strong medical knowledge in various therapeutic areas and many products’ portfolios. Currently, he conducts medical development programs.
- He was holding a position of Head of Global Patient Safety for Africa, Middle East, Turkey, Russia & CIS countries (82 countries) for 7 years in Merck in which he was managing more than 16 subordinates based in 8 different countries.
Currently he is a:
- Consultant for Medical Affairs, and Pharmacovigilance for Global, Regional and Local companies.
- Senior Auditor for an international EU-based firm.
- Speaker, Lecturer and Trainer for some colleges, companies, and health authorities.
Bio Ahmed Hegazy – June 2021
Dr. Rouba Eid, Regional Head of Pharmacovigilance
(Middle East/Africa), Bausch Health Companies
Dr. Rouba Eid experience in the region dates back from 2013 when she joined the industry after a career path at the US FDA. Her experience since focuses on pharmacovigilance systems setup, merges/integrations of PV systems, audit/inspection preparedness and PV operation in Middle East and Africa.
Dr. Eid received her Bachelor of Pharmacy degree from the Massachusetts College of Pharmacy in Boston, USA and her Doctorate in Clinical Pharmacy from Midwestern University in Illinois, USA. She obtained a Diploma in Epidemiology from the University of Bordeaux, France and completed a fellowship in the US FDA, Office of Compliance in Washington DC where she subsequently worked till 2013 . Prior to this, Dr. Eid served as the Associate Dean and Founder of the School of Pharmacy at the Lebanese International University of Beirut where she obtained 10 years’ experience in higher education management, training and curriculum development.
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