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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.
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.
Bio:
Career:
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
EXPERIENCES PROFESSIONNELLES
2008-2013 : Officine Privée à la Marsa-Tunisie
Poste occupé : Pharmacien assistant
Missions :
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
Missions :
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:
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.
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.
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.
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.
COMPETENCES
LANGUES
DIVERS
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.
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.
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.
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.
Patricia is a Pharm D. Grad. from ‘Saint Joseph University’, Beirut, Lebanon with 20 years of experience in the corporate pharma world (Novartis, Wyeth, Pfizer, Merck), mainly in the regulatory affairs arena.
She is currently heading the regulatory affairs of the healthcare business of Merck in the MEAR region: Middle East, Africa, Turkey, Russia & CIS countries; handling a wide & diverse team of RA professionals who are well engaged and acting as external pioneers in the industry via various trade associations i.e., IFPMA-ARN, IPASA, PhRMA, EFPIA: MERN, Russia-CIS & Turkey.
Since the beginning of her RA Career, Patricia was keen on enabling access of medicines and therapeutic solutions to patients around the world. Hence, she has been a highly active member in the industry via IFPMA/EFPIA/PhRMA associations and have contributed to multiple key events like pre-ICDRA, ICRDA, DIA MERC, Access to Innovation Webinars amongst many others, partnering with multiple Authorities in the MEA region.
Since March 2021, Patricia has been acting as the Chair of the PhRMA MEA RA Group; enabling, with the support of her seasoned esteemed peers, the design and implementation of multiple capabilities’ building programs for key Authorities in the MEA region like KSA, Algeria, Egypt & South Africa, which have been translated into enhanced and re-shaped policies & regulations.
Patricia’s belief is in passion to make great things happen with her motto being: “Regulate for a brighter future. Partner for earlier & better access”.
Sara is currently the Operations Director and Company Pharmacist for Laborex Kenya Ltd. and
Trade, Policy and Regulatory (TPR) Committee Chair for Kenya Association of Pharmaceutical Industry (KAPI).
She is currently pursuing a Master’s in Business Administration and a Master’s in Health Systems Management.
Her interests include personal and professional coaching, mentoring and training, music, books, sports and travel.
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 where 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.”
A pharmaceutical professional with over 13 years experience in strategic planning, business development, team leadership, and management of key stakeholder relationships in health
Over the course of her career, Daniella has focused on quality management systems for the health supply chain, as well as organizational regulatory compliance.
Armed with a strong passion for equitable health for all, Daniella is now involved in policy recommendations and idea mobilization in the pharmaceutical sector, towards attainment of universal healthcare coverage.
Education:
Moi University – Master of Science (M.Sc.), Public Health (Epidemiology) – ongoing
University of Nairobi – Bachelor of Pharmacy (B.Pharm.)
Languages: English and Kiswahili
Susan Lin is the Senior Manager: Health Policy Development for Medscheme Holding (Pty) Ltd. She is a qualified pharmacist with a Bachelor of Pharmacy from Rhodes University and has worked extensively in the healthcare industry. She has spent the majority of her career in health risk management / managed care.
Susan began her career serving as a dispensing pharmacist in public as well as private sector but later progressed to the Managed Care industry where she managed several portfolios. Her positions included the Executive Manager: Medicines Risk & Electronic Benefit Management and Specialist: Business Modelling & Coordination.
Her notable achievements was on the public and private partnership initiatives in enabling access to care. She consulted for a number of segments within the healthcare industry whereby she facilitated the streamlining of access to primary healthcare and development of technologies to support maternal and child care.
Currently, Susan is heading up the Health Policy Unit where she is responsible for the development of strategies for enabling access to pharmaceutical, technological and medical procedures. One of her ambitions is finding sustainable solutions in building reimbursement models to facilitate the funding of specialised medicines in South Africa.
Dr. Chourouk Bendhia is Regional regulatory portfolio optimization executive for Emerging Markets at GSK.
She holds a Pharm.D certificate with pharmaceutical industry background and regulatory affairs expertise at national (Tunisia) and international level.
She is responsible for leading and providing strategic direction and oversight to the Country’s regulatory teams, thus ensuring the development and execution of regulatory strategies and plans to meet business objectives.
Bunmi has over 30 years of experience in the pharmaceutical industry in Sales & mostly Regulatory Affairs (RA). She is a principled individual, passionate about integrity and business ethics, and a spirited team player.
She joined Pfizer in 1992 as a Medical Sales Representative and was appointed Regulatory Affairs Manager for Ghana and Nigeria in 1999.
In 2005, she was appointed as an Associate Director, Regulatory, Safety, and Quality to cover East, West, and Central Africa and her responsibilities have since increased.
She is a member of the IFPMA African Regulatory Network. She sits on various committees for the development of Regulatory Policies and Guidelines to support regulatory systems strengthening in partnership with local trade associations and other stakeholders.
Bunmi holds a bachelor’s degree in Pharmacy and an MBA from Obafemi Awolowo University, Ile-Ife, Nigeria.
She is passionate about developing people, building effective teams, and conflict management.a
Kiran currently heads up a cross functional data privacy team for Deloitte Africa and operates in the Risk Advisory Analytics and Cyber Security team. He has more almost 13 years of experience within the consulting industry across banking, insurance, mining, pharmaceuticals and telecommunications.
He has a strong focus in the Data Management and Privacy arena relating to Data Governance, Data Quality and the Protection of Personal Information Act (POPIA) with practical implementation of methodologies.
A Master of Business Administration in Finance, HEC is a business school Paris. More than 20 years of experience in the healthcare industry. Completed some 25 M&A transactions, with a particular focus on targets in home healthcare, clinical decision support, imaging and image-guided intervention and treatment.
Former European Regional Controller, Baxter Healthcare, Baxter’s $2.5 billion business. 2005, joined Philips; former Senior Vice-President and Chief Financial Officer, Philips Home Healthcare Solutions; then Senior Vice-President, Royal Philips, in charge of global strategy, business development and M&A, Philips Healthcare, the $13 billion in sales unit of Royal Philips based in Boston. Joined the World Economic Forum as Head Senior Director of Global Health and Healthcare in 2014 to then become the Head of Health Security Solutions, and a member of the Executive Committee at SICPA in May 2022.
In his years with as a member of the Executive Committee of the World Economic Forum, Arnaud Bernaert has launched defining public private coalitions in fields as diverse as epidemics preparedness, vaccines and antibiotics innovation, value based healthcare, precision medicine regulations, access to primary care, payment reforms, healthcare IT just to name a few. On such matters and many others, he also addressed as keynote speaker, panelist, moderator, or knowledge expert the participants of the most prestigious global healthcare gatherings in Davos, UNGA, Forbes conferences, World Health Assembly week, World Health summit and many other conferences.
Project Director with more than 17 years’ experience in line, project and operation management. I was involved in more than 150 trials from Phase I to Phase IV for different therapeutic indications, including but not limited to Infectious diseases like SARS COV, rare diseases with an extensive experience in the SCD indication, neurology, …etc.
For the past 2 years, I was involved mainly in setting up SARS-COV2 trials in Africa then in Europe and USA. I’m highly passionate about running clinical trials and strive to build capacity in Africa.
Harmandeep has over 11 years of experience on consulting across Middle East and South Asia region. He is currently working as Engagement Manager with IQVIA, Middle East team and has B.E. in Mechanical Engineering along with MBA from India.
Within IQVIA he has experience in serving clients across healthcare space which includes pharma, medtech, providers, regulatory authorities, and payers.
Dr Anthony Hama has a Doctor of Pharmacy (PharmD) degree from the Kwame Nkrumah University of Science and Technology (KNUST) in Ghana and an Executive MBA from the Paris Graduate School of Management. He has worked in the Pharma/medical device (IVD and Non-IVD industry) for the past 20 years in Ghana and abroad with managerial positions in Regulatory Affairs, Clinical Trials, Business Development, Project Management, and Marketing. His current role, since January 2022, is the Project Manager at the Navrongo Health Research Centre in Ghana where he is managing the Ghana component of the African Covid-19 Vaccine Safety Surveillance (ACVaSS) in African Advanced Market Commitment -92 eligible countries, a project being sponsored by GAVI and in collaboration with the Global Vaccine Data Network (GVDN) and African Leadership in Vaccinology Expertise (Alive).
Dr. Hama has also served as consultant for several world-class clients in the areas of pre- and post-market regulatory life cycle management in Ghana. He is an expert in pharmacovigilance and product safety.
Simge Sasmaz is a principal aligned to Consulting Services in IQVIA based in Dubai. Simge has strong expertise in consulting supporting local, regional, and international clients within the healthcare, including pharmaceutical companies, consumer healthcare clients and financial institutions. With over 15 years of pharma & strategy consulting experience in developed and emerging markets, she successfully led a wide range of consulting engagements, including geographic and therapy area expansion strategies, assessments for new therapies, portfolio prioritization, commercial due diligence, identification and evaluation of licensing opportunities and commercial design. Simge holds a BSc degree in Economics from Boğaziçi University and a masters’ degree in Economics from Sabancı University.
Qutaiba Al Manaseer is the Corporate Affairs Director for the Middle East & Africa (MEA) region at AstraZeneca. With more than 17 years’ experience in the biopharmaceutical industry, Qutaiba draws on his extensive knowledge and expertise to lead the Corporate Affairs agenda across the five core units which make up the MEA Area – African, Egypt, Gulf Corporation Council, Near East & Maghreb, and Turkey.
In this role, Qutaiba leads the strategic partnership agenda with government entities and the broader public sector, with a focus on building AstraZeneca’s reputation as a healthcare partner of choice – which includes leading communications and media engagement across MEA. Additionally, Qutaiba is responsible for driving critical conversations when it comes to policy shaping in key therapy areas: oncology; cardiovascular, renal & metabolic; respiratory and vaccine & immune therapies.
Qutaiba joined AstraZeneca in 2020 to lead the partnership agenda with governments across MEA, and specifically to roll out the AstraZeneca vaccine and long-acting antibody. Prior to joining AstraZeneca, Qutaiba worked at another multinational pharmaceutical company for 15 years, in a range of functions spanning market access and commercial roles in Jordan, UAE and KSA. Qutaiba has also had the opportunity to work with Amref Health Africa in a volunteering assignment in Kenya, which has helped shape his patient-centric and innovative mindset.
A proactive leader, team builder and tactical planner, Qutaiba is also a strong advocate of gender parity, diversity and inclusion in the workplace.
In addition to his AstraZeneca role, Qutaiba is on the Emirates Health Economics Society board as the Media and Public Relations Chairman. Qutaiba holds a Master’s in Health Economics from the Barcelona School of Management, an MBDA from the Swiss Business School, Switzerland and a Bachelor’s degree in Pharmacy from the University of Jordan.
With over 40 years of experience gained across all business areas and numerous industries, Ms. Angela has uniquely placed herself to be able to operate strategically and operationally within the Clinical Research Arena.
She has qualifications in Hotel Management, honours in Industrial Psychology and is a Chartered Accountant. Angela has, over the years undergone intensive leadership training at Eli Lilly SA (Pty) Ltd, Emotional Intelligence courses, Employment equity, Labour, Tax and Corporate Governance updates.
Lifelong learning is one of her key beliefs and training and development is encouraged at all levels of the organization. Ms. Angela has represented Eli Lilly at IMSA and ACRO at PIASA, both key Industry organizations.
She was active on a task team at Endeavor SA, identifying and refining the process for talent management in organizations and for entrepreneurs. Ms. Angela started her career in the pharmaceutical industry in 1989 and has gained experience across all aspects of the business from HR, Finance, Risk Management, Operations and Corporate Governance. She has also been responsible for company startups as well as the establishment of legal entities in Kenya
Dr. Catherine Mwendwa Maina (Kenya) is a pharmacist with over 13 years’ of experience in the industry (community, hospital and industrial pharmacy). She is currently the Regulatory Affairs Lead East Africa & Sub regional LPVRP –Kenya at Glenmark Pharmaceuticals Ltd. She is keen on leadership, thrives in problem solving activities, takes pride when out of box thinking enables business growth and development. She is involved in policy development and implementation of regulatory and quality assurance of medical products and health product technologies. An action-oriented member of the Pharmaceutical Society of Kenya. Her day to day includes MP/HPT submissions, LCM, AE/ADR/PQC reporting, PV related periodic submission, Oversight of PV function in selected countries, Business support and Regulatory intelligence.
Catherine holds a BPharm & MBA – International business from the University of Nairobi, Post Graduate Cert – BIRS and pursuing Master’s degree – BIRs (Biotechnology Innovation and Regulatory science) from Purdue University.
John currently works at Bayer as Head of Regulatory Affairs responsible for East & West Central Africa Region based in Kenya, responsible for Pharmaceuticals and Consumer Health divisions and doubling up as Regulatory Policy & Intelligence Lead for EEMEA Region. He has previously held different roles in Pharmacovigilance and Quality Control within the Pharmaceutical Industry. He has been an active member of several industry associations including KAPI (Kenya Association of Pharmaceutical Industry) where he has served as member since 2013 including as past executive secretary and continues to serve in in various committees within KAPI and as Board Member.
John is passionate about supporting the streamline of Pharmaceutical Regulatory Systems & Policy and is currently a member of the Africa Regulatory Network (ARN) within the IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) where he is the immediate past co-chair. Additionally, John represents Bayer in the Africa Engagement Committee of the IFPMA and is currently a member of the Africa Strategy for the Global Self Care Federation (GSCF).
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.
Stavros Nicolaou is the Aspen Pharmacare Group’s Senior Executive responsible for Strategic Trade Development. Previously he was CEO of Aspen’s Export Business. Aspen is Africa’s largest pharmaceutical manufacturer and a now world leader in Anaesthetics and injectable anti-coagulants. Aspen is one of South Africa’s most globalised multinational companies with a presence in over 50 geographies globally, with 26 manufacturing facilities across 6 continents. He was instrumental in introducing the first generic ARV’s on the African Continent developed by Aspen, which has gone on to save hundreds of thousands of lives in South Africa and on the African Continent.
Nicolaou has over 30 years’ experience in the South African and International Pharmaceutical Industry and is a previous winner of the SA Institute of Marketing Management (IMM) Health Care Marketer of the year Award. He was a previous recipient Monty Rubenstein Award for proficiency in Pharmaceutics from the Wits University Pharmacy Faculty. He was awarded, the Order of the Lion of St Mark by the Greek Orthodox Pope Theodoros II and recently received the title of “High Commander of the Order of the Apostle & Evangelist Mark” of the Patriarchate of Alexandria. He has been inducted as a Fellow of the Pharmaceutical Society of South Africa (PSSA), one of the highest honours bestowed by the PSSA, and was recently awarded an Honorary Doctorate in Medicine from Wits University.
He has been a speaker at a number of conferences, including the Economist Roundtable, the World Economic Forum (WEF) and recently delivered a lecture on ARV developments at the Raigon Institute, a JV between Harvard Medical School and the Massachusetts General Hospital.
He has previously and continues to serve on a number of Industry & associated structures, some of which include
Emeka Chukwurah currently leads the Regulatory Affairs Projects Team at CQRAFF Solutions Ltd. His 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.
In his current role he advises clients on: Regulatory Strategy 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.
CQRAFF Solutions is a company incorporated by law in Nigeria to render Corporate Regulatory Affairs services to Cosmetics, Pharmaceuticals, Medical Devices & Diagnostics, Food & Nutraceuticals companies/manufacturers with strong presence in Nigeria and Ghana.
Mr Rostand SAGU Kenfack is a Quality control and Quality assurance engineer, international regulatory expert for pharmaceutical, food and cosmetic in French speaking African countries. He is a holder of a master’s degree in quality and Assurance Control for Drugs, Foods and Cosmetic, a Master degree in Clinical Biochemistry, both obtain at University of Dschang in Cameroon.
He is having also an Assistant Project Manager Diploma in Clinical Trial, from the Clinical Trial Evaluation Center Timone Hospital Aix- Marseille University France. He has followed up many regulatory certifications training in Dubai, Ivory Coast and Cameroon. He is the Director of Quality & Regulatory Affairs at Institut Africain du Médicament (IAM) an international company in the pharmaceutical and cosmetics sector (Helioscience) based in Douala (Cameroon) and Marseille (France), which works for the improvement of quality and healthcare system in Africa, Registration assistance and regulation compliance for French speaking countries and distribution of pharmaceutical products.
Mr Sagu is member of international organization such as Industrial Pharmacy Section of the International Federation of Pharmacist (FIP), BackOffice Manager of the African Pharmaceutical Forum (APF) and promoter of Dubai International Pharmaceuticals and Technologies Conference and Exhibition – DUPHAT, in Africa since 2018. He is married and father of one.
Hala Abu Ghazalah, Head of Regulatory Affairs, Africa & Middle East
Pfizer Biopharmaceutical Group with 25 years of experience in Regulatory Affairs, External Affairs, and Marketing, supporting various healthcare categories.
Pharmacist by education, licensed in both UAE and Canada.
