She has 19 years’ Experience as Regulator Covering different roles in in various fields as Good Clinical Practice – Good Pharmacovigilance Practice – Regulatory Affairs – Pharmaceutical Production – Quality Assurance – Technical Methodology – GMP Inspection – Health Care Quality , key functions such as Quality Compliance, Documentation, Personnel, Biosafety, Performance Improvement, Validation, and, Strategic Planning, Quality System Management, Management of Quality Function, Project Planning and Initiation, Quality Control Techniques, Production Steps through GMP Trainings and reviewing Manufacturer`s Master files and production summary protocols and working as operation and facility Manager in a Pharmaceutical Company During its renovation phase. And also responsible for assessing and evaluating and monitoring Conduction of different phases of Clinical Trials and also as being QPPV.

Furthermore, she has gained significant experience working through EDA task force through the journey of achieving ML 3 in Vaccine scope according to World Health Organization GBT

Rehab is the Manager of the general Administration of Pharmaceutical References and inserts, Central administration of Pharmaceutical Care, Egyptian Drug Authority

She is a board-certified Pharmacist in pharmacotherapy with a Master’s Degree in the field of clinical biochemistry and oncology

She has completed the clinical research scholarship at Harvard Medical School, postgraduate studies in Policy Development and Advocacy for Global Health at the University of Washington and The advanced leadership skills” training program by the National Training Academy.

Over the span of more than 15 years, Rehab has gained extensive experience in various areas of the life sciences sector, with a focus on Regulatory Affairs, Pharmacovigilance, Patient Safety, Drug/Medicine Information, Medical Affairs, Clinical Pharmacy, and Hospital Accreditation Standards.

In her role as the General Manager of Pharmaceutical References and Leaflets, She and her team lead the Electronic Labelling Project and they feel honored to be pioneers in the Middle East and Africa.

She participated in a number of strategic projects, such as the WHO rational Drug use survey, And also was among many expert Working Committees responsible for achieving the “Egyptian Clinical Pharmacy Standards of Practice”, “Egyptian guidelines of Medication Management standards” and Guidelines for Classification as Nonprescription Medicinal Products (OTC).

Dr. Doaa Rady is a highly experienced regulator who has dedicated her career to ensuring the quality, safety, and efficacy of biological products. With over 10 years of experience in the biological product sector, she has developed a deep understanding of the regulatory landscape and is widely recognized as an expert in her field.

She began her career as a lot release specialist at National Organization for Research and Control of Biologics, where she was responsible for release process for several biological products including vaccines and plasma derived medicinal products. During her tenure, she gained extensive experience in different regulatory functions.

Over the course of her time at the Egyptian regulatory authority, Doaa held several leadership positions, including serving as a team leader for the team establishing the risk-based lot release policy in Egypt, team leader for lot release team achieving WHO ML3 for LR function during benchmark of EDA, Egypt, and deputy of lot release department manager. In these roles, she was responsible for overseeing the review of a wide range of biological products, as well as she has active participation in many working groups responsible for providing guidance to industry on regulatory requirements and best practices.

She has also been an active participant in several professional organizations, including the International society of Pharmacoeconomic & outcome research (ISPOR) and the African Medicine Quality Forum technical committee which is One of the key components of The African Medicines Regulatory Harmonization (AMRH) initiative.

She has served on various international committees and working groups at ISPOR including Health equity special interest group, clinical outcome special interest group, real world evidence interest group and biosimilars interest group.

She had the opportunity to provide her feedback and insights to different regulatory guidelines and papers including ICH- Q9 quality risk management guideline, ICH-Q14 analytical procedure development, WHO approach towards the development of a global regulatory framework for cell and gene therapy products, ISPOR report on mapping HTA agency approaches for biosimilars value assessment and Primer on health equity research in health economics and outcomes research an ISPOR report. Moreover, Doaa Rady serves as peer reviewer for value in health journal and has active participation in reviewing research manuscripts and abstracts.

Doaa Rady holds a Bachelor of pharmaceutical science from the Helwan University, Egypt, a Master of Science degree in Microbiology & Immunology from Cairo, Egypt and Pharmacoeconomic and Health Technology Assessment Diploma from Cairo university in cooperation with Bournemouth university in UK She is a recognized leader in the field of biological product regulatory authority and is highly respected by her colleagues and managers.

Dr. Boutarene El Khaldia Nabiha, Director of Technical Monitoring, Inspection and Vigilance.

Previously head of the technical monitoring unit at the national agency of pharmaceutical products. Head of the Registration Department, then Head of Department at the National Laboratory of pharmaceutical products.

Biological engineer with quality control and analysis option, analysis at the national laboratory for the control of pharmaceutical products since 2013, auditor for the validation of quality control laboratories since 2016, inspector in the joint Anpp/Ministry of Commerce brigades since 2021, Currently I hold the position of technical-regulatory deputy director at the registration department of the national pharmaceutical products agency since April 2023.

Vanessa currently leads the work on regulatory and policy reforms under the African Medicines Regulatory Harmonisation Programme at AUDA-NEPAD, primarily focusing on coordinating and facilitating the development and implementation of legislative frameworks that enable African Union member States to effectively and efficiently regulate medical products. She has over 12 years of experience in policy advocacy and communication as well in project and grants management in various sectors including health.  She holds and Bachelor of Science Honours Degree in Sociology from the University of Zimbabwe, a Post Graduate Diploma in Public Health from the University of Pretoria and she is a certified PRINCE 2 project manager.

Ropafadzai Hove is a public health professional, with more than thirty years experience in medicines regulatory affairs and policy co-ordination at national, regional, and international levels.

As Chief Regulatory Officer at BoMRA, she provides technical and strategic direction to the Technical Teams in the regulation of medicines, medical devices, and cosmetics.

She chaired the Pharmaceutical Advisory Committee in the Southern African Development Community (SADC) resulting in the establishment of the SADC work sharing initiative for medicines regulators, ZaZiBoNa.

Ropah is a pharmacist, with a Masters of Science degree in Pharmaceutical Services and Medicines Control from Bradford University, United Kingdom.

Silverani Padayachee is the Senior Manager: Pharmaceutical Evaluation Management at SAHPRA and oversee five subunits of quality and bioequivalence of small molecules, registration of  biological, complementary and veterinary medicines. Silverani holds a Masters in the area of Pharmaceutics with over 30 years experience as a pharmacist in various fields of pharmacy i.e. in academia; hospital; manufacturing, clinical trials; pharmacovigilance, retail; research and over fifteen years experience in pharmaceutical quality, regulation and control at the Regulator (MCC and SAHPRA). Silverani has been invited by WHO Prequalifications of Medicines Programme (WHO PQ) to assist with assessments of medicines.

Silverani has participated in various health collaboration initiatives relating to Health System Strengthening and have been invited to speak on behalf of these initiatives at International conferences such as ICDRA (International Conference of Drug Regulatory Authorities) organized by WHO and to also chair international harmonization meetings.

Silverani also holds a Masters in Education with specialization in Adult Education and believes that adult learners are experiential learners  and the work environment is a key element in expanding the knowledge base of any field, all that is needed is to encourage and support people to share these learnings with others. Hence ongoing training or mentorship is key in ensuring that members of her  team are capacitated to ensure current global review standards are maintained.

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.

Abebe Alamneh Kassahun is a dedicated professional with a strong background in the field of medicine regulatory affairs. He holds a Bachelor’s degree in Pharmacy and a Master’s degree in Medicine Regulatory Affairs from Addis Ababa University.

Currently, Abebe serves as a Medicine Registration Expert at the Ethiopian Food and Drug Authority (EFDA), where he plays a crucial role in ensuring the safety, efficacy, and quality of pharmaceutical products in Ethiopia. With his expertise, he actively contributes to the regulatory processes involved in the registration and approval of medicines, ensuring compliance with national and international standards.

In addition to his role at EFDA, Abebe also holds the esteemed position of Vice Chairman at the East African Regulatory Affairs Professionals Association (EARAPA). As the Vice Chairman, he demonstrates exemplary leadership skills and actively participates in shaping the regulatory landscape within the East African region. Abebe collaborates with fellow professionals to develop harmonized regulatory frameworks, facilitate information exchange, and promote best practices in medicine regulation.

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.

Amos is a pharmacist with over fifteen years of comprehensive domestic and international experience in drug regulation and policy formulation. Studied Pharmacy and Finance and is studying Master of Science in Pharmacy Administration and Policy Regulation.

Started his regulatory journey in 2006 working as an inspector of drugs at the ports of entry. Led South Western and Northern regions as a Regional Inspector of Drugs for over 10 years and briefly acted as head of enforcement. Thereafter coordinated the implementation of Good Distribution Practices and Good Pharmacy Practices for Pharmaceutical products.

Is a trainer and lead GMP inspector who has inspected over 160 pharmaceutical manufacturing facilities in Africa, Asia, Europe, and United States for compliance with Good Manufacturing Practices.

Currently working as a Senior Inspector of Drugs and NDA representative to the Allied Health Professionals Council. Have great interest in emerging trends in regulatory policy and how it affects access to medical technologies.

Eager to learn, grow and excel in regulatory policy and public health so as to contribute to team success through hard work, patriotism, attention to detail and excellent organizational skills.

Dr. Elvis Temfack works at Africa CDC as Senior Research officer, based in Ethiopia. His background training is in clinical medicine and public health with over 15 years’ experience in clinical research and comprehensive clinical case management. Prior to joining Africa CDC, he joined Epicentre of Médecins Sans Frontières in Paris, a World Health Organization (WHO) collaborating Centre for Research in Epidemiology and Response to Emerging Diseases, working in Malawi for three years as field principal investigator generating relevant clinical evidence to support Malawian ministry of Health change pf policy for HIV first-line treatment from Efavirenz to Dolutegravir-based therapy.

He is a member of the European Society of Microbiology and Infectious Diseases (ESCMID), the International Society of Human and Animal Mycology (ISHAM) and a contributor to the Mycology One World One Guideline working group, an initiative of the European Confederation of Medical Mycologist (ECMM), ISHAM and American Society of Microbiology initiative (ASM). He has co-authored many peer reviewed publications in high readership international journals and is associate editor in some international journals. He is also a member of many collaborative working groups, serving in scientific and advisory groups addressing research in human health.

He is a pharmacist by training and graduated with Masters of pharmacy in Pharmacoepidemiology and Pharmacovigilance from University of Nairobi and recently completed a fellowship program in Anti-Microbial Resistance (AMR) from the London School of Hygiene and Tropical Medicine.

He is a chief principal regulatory officer at the Pharmacy and Poisons Board, in the department of product safety, having worked with PPB for over ten years across several regulatory functions which include regulatory inspections, clinical trials, pharmacovigilance and post-marketing surveillance. He has special interest in drug utilization studies and medicines regulatory science.

Richard is a pharmacist with 26 years’ experience starting off his career in hospital pharmacy in the public sector.  He has spent the last 19 years in the regulatory profession in various capacities.  He is currently the Director-General at the Medicines Control Authority of Zimbabwe.

Rosemary Nkemdilim Onwualu is a Scientist, GMP inspector, Lead Quality Auditor certified, and a regulatory Inspector with over 10 years in pharmaceutical GMP inspections and twenty three years’ experience with National Agency for Food and Drug Administration and Control [NAFDAC] Nigeria. Saddled with the responsibility to regulate medicinal products and medical devices. Rosemary is an experienced leader in the conduct of QMS internal auditing, inspection readiness activities, SOP development, quality document management, training, and technical paper reviews. She is recognized for her expertise in implementing QMS principles across settings and systems, a member of the quality team of her NRA, an active member of the NAFDAC-WHO GBT Team and has presented as subject matters topics regarding quality policy, quality objects, and other related matters.

She is the Nigerian Deputy GBT national focal person, that derived and championed the coordination and supervision of the Nigeria NRA GBT Program for Regulatory Inspection and Clinical Trial Oversight functions respectively to the successful attainment of maturity level three [ML3].

She contributed to several initiatives in terms of development of policy, guidance documents for Good Regulatory Practice in Nigeria.

A resource person in system strengthening programs, capacity building, training including mentoring of other NRAs on GBT Program in Nigeria and the Cote divoire for the attainment of ML3.

She participated in the review of WHO Listed Authority (WLA) guidance document.

Folasade is a Chief Regulatory Officer, at the National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria’s Medicine Regulatory Agency.

While Folasade’s primary role in NAFDAC is to implement Quality Management Systems in line with ISO 9001, ISO 17025:2017 and WHO Standards at the National Quality Control Laboratory. She works on the Technical Working Group of the NAFDAC Traceability Office, supporting the execution of the five-year roadmap for implementing pharmaceutical traceability in Nigeria.

Folasade also serves on the NAFDAC-WHO Global Benchmarking Team. This team was constituted in 2018 to drive implementation and institutionalization of WHO Global Benchmarking Requirements in Nigeria’s regulatory System. Folasade coordinates the Laboratory Testing Function on this project. In 2022, the team’s efforts led to Nigeria attaining the WHO GBT Maturity Level (ML) 3 i.e. status of a stable, well-functioning and integrated regulatory system

Folasade trained as a pharmacist, at the University of Lagos, Nigeria. She has a master’s in public health (MPH) from the University of Western Cape South Africa and a Master of Public Policy (MPP) from the University of Oxford, UK.

Dr. Ibrahim Mustafa

Vice President of the General Authority for the Economic Zone of the Suez Canal for Investment and Promotion Affairs Since his assumption in January 2023, he has been working to achieve several goals to improve the investment environment, develop infrastructure, and increase industrial and logistical investments, by focusing on sectoral and geographical promotion.

Prior to his position, he held several positions as follows: Dr. Ibrahim Mustafa, Executive Director of Tariq Company for Economic and Financial Consultations Consultant to the first economic partnership councils in an American company and former senior advisor to the Minister of Investment Consultant to a number of local and foreign companies in the field of investment and development and an expert in economics, investment and business development – former economics lecturer for MBA students at Canadian Memorial University..

Former Senior Adviser at the Ministry of Investment and former General Coordinator of the Economic Conference (Sharm) El-Sheikh in March 2015- and a former advisor at Price Water House and Allen & Overy..- Former founding partner of Masarat Consulting. 2016-2018 Member of the Board of Directors of Collins Insurance Brokerage Company Member of the Board of Directors of Our Advisory Member of the Young Businessmen Association

Holds

Bachelor of Economics and Political Science from Cairo University 1998 Master’s degree in political economy, Cairo University, 2010 Mini Master of Business Administration accredited by Cairo University 2012

PhD in political economy

Cairo University 2021

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.

With more than 20 years’ experience in the Pharmaceutical Industry, Dr. Feirouz strongly believes that working for a Healthcare provider, our mission is to improve people’s life. Our role is to bring innovative solutions to serving the communities and enhancing their quality of life.

During her journey she got the opportunity and the pleasure to experience different roles, under different scopes in different countries moving from pure manufacturing function to regulatory, to government affairs before taking the leadership and the ownership of the consumer Healthcare business in Tunisia, North Africa and very recently in Egypt.

More than 15 years’ experience in the Pharmaceutical Industry,

My career journey is diverse, and I had the pleasure to experience different roles in the pharmaceutical industry starting from Sales moving to Sales Force Effectiveness and then shifting to Regulatory, where  I found my passion and kept progressing in my career development till reaching my current role as “Africa Science Affairs Head in Sanofi Consumer Healthcare” responsible for all the science functions (Regulatory – Medical – Quality & Pharmacovigilance) across Africa.

Dr. Aliou NDIAYE, esteemed pharmacist and specialized in the digitalization of the healthcare system and the development of digital health solutions, is a distinguished leader in the field of health innovation and the development of AI-based medical technology.

Dr. Aliou holds three degrees from UCAD: a Doctorate in Pharmacy from the Faculty of Medicine, Pharmacy, and Dentistry (FMPO), a Master’s in Health Facilities and Programs Management from the Faculty of Economics and Management (FASEG), and a Master’s in Project Management from the School of Applied Economics (ESEA).

He is also certified in agile project management with SCRUM, and implementation research. Additionally, he has training in evaluating drug marketing authorization (MA) application dossiers and clinical trial implementation requests.

Throughout his career, Dr. Aliou has worked on the digitalization of the healthcare system, particularly focusing on digitizing patients’ medical records, care pathways, and health services in Senegal. He has also been involved in situational analysis and addressing issues related to the dispensing and misuse of medications containing codeine.

Currently, he is serving at the Senegalese pharmaceutical Regulatory Agency (ARP), where he is working on implementing a drug serialization system.

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 14 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.

Yarmouk University:

• 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 5^thyear 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).

Hala Abu Ghazalah, Head of Regulatory Sciences, Africa & Middle East, Pfizer

Hala has over 25 years of experience in Pharmaceutical and Healthcare industries and had several leadership roles within Regulatory Affairs, External affairs, and Marketing

Pharmacist by education, licensed in both UAE and Canada

Dr. Sahar Ebrahim is a seasoned Public Health Physician with over 28 years of experience in the biopharmaceutical industry. She obtained her medical degree from Alexandria University and has since dedicated her career to clinical research. Currently serving as the Regional Head of Clinical Operations for the MENA region, Sahar is based in Egypt.

For the past 17 years, Dr. Sahar has been an invaluable member of Quintiles/IQVIA, where she has made significant contributions to the field. Her expertise extends across various regions, including Egypt, Levant, Gulf countries, and North Africa. As a certified Good Clinical Practice (GCP) trainer, Sahar has trained numerous professionals in the industry.

Throughout her career, Dr. Sahar has been involved in over 750 clinical trials, spanning phases I to IV, and has successfully recruited more than 55,000 subjects across 250 sites. She has collaborated closely with regulatory agencies in Arabic-speaking Middle Eastern and North African countries, conducting landscape assessments and benchmarking against more mature markets. Sahar has also organized regulatory workshops to share best practices and develop transformation roadmaps.

With an impressive track record, Sahar has conducted 80 site audits, 12 system audits, and 18 regulatory inspections. Additionally, she has played a pivotal role in streamlining business processes through strategic partnerships. Sahar’s contributions have been instrumental in supporting the expansion of a Prime and partner sites Network in the Middle East.

With her wealth of experience and deep understanding of the biopharmaceutical industry, Dr. Sahar Ebrahim continues to make significant strides in advancing clinical research and healthcare outcomes across the MENA region.

Konstantin has more than 15 years’ experience in IT products and implementation of complex B2B solutions for large and medium-sized companies. Six years ago, he set up Utrace, with the aspiration of making the complex and expensive process of compliance smooth and efficient by providing scalable, user-friendly and cost-effective solutions with high levels of automation. Now, six years later, Konstantin is proud to say Utrace has helped over 50 companies in the pharma and FMCG industries successfully comply with a host of complex requirements.

Arif is the Director of Business Development at Utrace and expert in Track & Trace management, IT project management, Supply chain processes organization and post-implementation technical support. Since 2011, Arif has participated in various implementation projects in large logistics, pharmaceutical and FMCG organizations. Arif is an evangelist of Track&Trace Technologies and has conducted dozens of webinars and consultations on building serialization processes in production and logistics functions.

His primary role is to achieve the milestones set to meet the strategic vision and direction of the organisation. He has 18 years of expertise in anti-counterfeit packaging technology, global pharmaceutical Serialization, Supply chain traceability, Product Authentication and Quality Control for the pharmaceutical industry and strives to develop better technological practices in the sector. His mission is to enhance productivity and quality, ultimately providing end consumers and patients with better outcomes. His vision is for ACG to lead in the technology and solution space for the pharmaceutical industry beyond regulation, setting new benchmarks to make it better.

With over 17 years of diverse experience in the clinical trial field, Ms. Bicky currently works as a freelancer, serving as the Director at a CRO named AfriLeadTech Research (PTY) LTD and holding the position of Chairperson at The South African Clinical Research Association (SACRA). Ms. Bicky is driven by a passion for growth and excellence within the clinical research industry. Her journey has encompassed various leadership roles, including Project Operations Director, Local Clinical Trial Manager, and Regional Study Manager across Africa, Asia, and Europe.

A Results-Driven Project Manager:

Ms. Bicky excels in overseeing and managing project operations both locally and globally. As the Project Operations Director, she led a team of dedicated Project Managers and successfully delivered high-priority services to valued clients.

Seasoned Clinical Trial Regulatory Expert:

Ms. Bicky’s expertise lies in regulatory matters; her entry into the clinical research field began with SAHPRA when it was called MCC. Specializing in streamlining regulatory processes and timelines, she ensures a seamless and efficient journey. With a keen eye for detail, she manages intricate regulatory requirements, documentation, and communication with authorities. Leveraging her strategic insight and extensive expertise, she accelerates the initiation and progress of clinical trials in South Africa.

Training, Quality, and Compliance:

Ms. Bicky takes pride in crafting comprehensive SOPs and training programs for CROs and Research Sites. Notably, she developed a 6-month CRA Training Program and Accredited GCP material.

Driving Ethical Research Practices:

With a profound understanding of ethical guidelines, including GCP and the Declaration of Helsinki, Ms. Bicky collaborates with ethics committees and IRBs to ensure ethical conduct in clinical research. Currently, she leads the SACRA input to the ICH GCP R3.

SACRA Chairperson | Strategist and Ethical Advocate | Entrepreneur:

As the SACRA Chairperson, Ms. Bicky advocates for clinical trials and mentorship programs, consistently sharing knowledge and staying updated about the latest changes in the clinical trial landscape. Leading the SACRA international clinical trials day for the past three years stands out as a career highlight. Functioning as a strategist, enthusiast, and entrepreneur in clinical research, she founded a flourishing clinical research site that contributes significantly to capacity building in South Africa.

Neveen holds degree of Bachelor of Pharmacy – Faculty of Pharmacy – Cairo University. She is currently Head of Regulatory Affairs North Africa, Egypt  & Africa Developing Markets at Merck, supporting regulatory policy advocacy efforts for the region. She has over 20 years of experience in industry and 16 years of them as Regulatory Affairs, Prior to Regulatory Affairs she worked in several Multinational companies in different roles Commercial, Quality, Pharmacovigilance, Market Access & pricing. Neveen is also an active member of several trade associations including IFPMA Africa Regulatory Network (ARN); PhRMA Egypt Regulatory working Group; She participated in writing the Position paper for Registration Sampling & QC testing (IFPMA ARN)

He graduated from the Faculty of Pharmacy in 2008, then he joined the marketing, sales and Business administration diploma at the American University in Cairo and the Naval Academy as well.

He started his career in the Egyptian Drug Authority (formerly the Ministry of Health and Population) in 2013 and worked gradually until he reached the Head of Digital Transformation in EDA.

His big focus was managing the track and trace project in Egypt from 2018 until 2020 adding to that he managed to transform the registration to be automatically and having company profile for each entity registering in EDA then he decided to move to GS1 Egypt, where he is responsible for helping in implementing the GS1 standards in the healthcare sector and continuing to manage track and trace and other projects such as the UDI project for medical supplies, which was implemented in Egypt in 2021-2022 and other projects related to the health care sector in Egypt.

She has over 10 years of experience in Regulatory Affairs and Government Affairs. She has worked at GSK as the Regulatory Affairs Director for FWCA, OWA and East Africa region. She is well versed with the Africa Regulatory environment and has wide array of achievements in product registrations, divestments, license maintenance, renewals, artwork, labelling, government affairs and strategic planning to support business objectives.

She has a strong skill set in advocacy, legislation, government affairs and is currently the Chairperson of the Kenya Association of Pharmaceutical Industry (KAPI). She has led the industry association in advancing regulations, advocacy, and stakeholder engagements to positively shape the pharmaceutical Industry within East Africa. She is also a council member of Africa Engagement Committee, committee member of the Africa Regulatory Network and Regulatory Science Committee in IFPMA.

With more than +5 years of a demonstrated history of working in bio-Pharmaceutical and Pharmaceutical industry holding a bachelor degree of Pharmacy from Future University in Egypt, started my career in the academic field as a teaching assistant at Faculty of Pharmacy, Future University in Egypt, moved to regulatory affairs field in Biological Registration General Directorate in the Egyptian Health Authority., then Joined Amgen As Sr. Regulatory associate for Egypt & Iran and got promoted to Regulatory Affairs Manager for Eli countries.

At present, Ms. Mariham Gergis holds the position of the designated sub-team lead for life cycle management at EMEA Regulatory Management Center, where her scope of responsibility extends to the non-EEA region. She brings to the table a valuable nine-year span of local and regional regulatory experience.
Ms. Gergis embarked on her regulatory journey in December 2014 at MSD Egypt, assuming the role of Middle East labeling specialist. Through her tenure at MSD, she traversed through multiple roles, encompassing both labeling and regulatory capacities at the local level. Her oversight extended to pivotal areas like oncology and diabetes franchises.
In March 2020, Ms. Gergis transitioned to Janssen, the pharmaceutical entity under Johnson & Johnson, ushering in a new phase of regional engagement. Within the EMEA Regulatory Management Center, she assumed the mantle of Life Cycle Management, catering to the regulatory needs of the Jordan Egypt North Africa cluster /GCC, alongside the Kenya Nigeria Ghana clusters. Her journey within the organization culminated in a well-deserved promotion to her existing role.

Dr. Manal El-Sayed (Cairo, Egypt) is Professor of Pediatrics, Chair of the Pediatric department and director of the Clinical Research Center (MASRI-CRC) at the Faculty of Medicine, Ain Shams University.

Dr El-Sayed is a founding member of the Egyptian National Committee for Control of Viral Hepatitis (NCCVH) since 2006. She contributed to the establishment of a nationwide network of more than 120 specialized liver centers providing antiviral therapy for more than 3.5 million HCV-infected patients. Manal collaborated on the development of the national action plan for prevention and control of viral hepatitis published in 2014 with representatives from WHO, U.S. CDC, Pasteur Institute, and national stakeholders. In addition to co-supervising the nationwide mass screening program for adults and clinical director of the school screening program reaching so far more than >62 million people.

Manal is the secretary general of the Egyptian Liver Care Society, an NGO offering financial assistance to patients receiving hepatitis treatment or liver transplants as well as children with chronic viral hepatitis. She authored and co-authored numerous journal articles on hepatitis and participated in the development of the WHO’s global HBV, HCV and diagnostic guidelines. Between 2011-2015, Manal was Vice Chair of WHO’s technical advisory group for prevention and control of viral hepatitis in Egypt and is member of the Global Accelerator for Paediatric Formulations (GAP-f). She is governing board member of the International Coalition for Elimination of hepatitis B (ICE-HBV) since 2020 and among board of directors for the Hepatitis Fund (EndHep2030). In addition to co-organising and co-chairing

numerous international meetings on viral hepatitis and liver disease in Europe, US and Africa.

Professor El-Sayed co-founded and co-chairs the Conference on Liver Disease in Africa and is the President of the Society on Liver Disease in Africa (SOLDA). She received the Egyptian State Appreciation Award in advanced technological sciences that serve the fields of medical sciences in 2022.

Dr. Marielouise Abi Hanna, PharmD, boasts an impressive career spanning over 25 years, during which she led various roles within the pharmaceutical industry. Her expertise extends across Market Access, Global Regulatory Affairs, and Corporate functions, both at global and regional levels. Driven by a commitment to excellence, she has contributed to the success of major multinational corporations, including GlaxoSmithKline, Novartis, Sandoz, and Acino, covering Pharma, Biotech, and Generics.

In 2018, Dr. Abi Hanna embarked on a new venture, founding The Reg.Cloud, a specialized pharmaceutical consultancy. The Reg.Cloud provides invaluable services in Corporate Strategy, Due Diligences and Acquisitions, and is a trusted partner in driving Market Access throughout the product lifecycle.

With a global perspective, The Reg.Cloud empowers both emerging Small to Medium-sized Pharma Enterprises and established Multinationals to expand their reach, with a particular focus on markets spanning the Middle East, Africa, Asia Pacific, CIS, and Eastern Europe.

With over 18 years of experience in regulatory access and market intelligence healthcare industry, I successfully assisted different MAHs, manufactures and companies in developing innovative strategies for entering new markets, focusing on all different market access perspective such as BD, regulatory, pricing and vigilance considerations.

Through my career in different healthcare stakeholders of which Shocair Group (Arab Drugstore, Arab Medical and scientific Alliance and Amsterdam Medical and scientific Alliance )which I served for more than 15 years which id Shocair group, I successfully established and managed different operational departments such as supply chain, quality compliance, in addition to regulatory and intelligence department, which gave me enrichment exposure to registration experience in different regions and from different perspectives. Moreover, I was part of the teams responsible for revision of different JFDA regulations, member in drug owner association, in addition to my active participation as a keynote speaker at numerous healthcare industry events, I regularly provide updates on the latest trends in regulatory affairs. Additionally, I serve as a business coach and trainer, helping companies unlock the potential of their employees through technical training and personalized coaching.

As for my qualification; by educations I`m a pharmacist with two master degrees; Public Health and MBA which both supported my remarkable achievements in different scopes. Moreover, through continuous education and commitment to unremitting learning I gained different professional certifications in different regulatory access and market intelligence fields such as quality pharmacovigilance auditing (International Colleague of London),  Professional GCC Regulatory Affairs Certificate (Dubai Pharmacy College), Certified Innovation Associate (GIMI), and Vocational Diploma in Regulatory Affairs of Pharmaceutical Products &Market Authorization (University of Jordan)

Recently, I`m working as a Regulatory Access and Market intelligence Strategist and Consultant through which I help companies to strategies their regulatory access in different countries with thorough market assessment. Support different MAHs in their regulatory projects within the region through creating innovative solution when coming to challenges faced with authority or other stakeholders. Furthermore, I create and implement effective business coaching plan for companies that positively reflected in their team achievements and increased quality of their work deliverables.

Dr. George Kamal is Regional regulatory Affairs Head for regulatory Hub based on Egypt and supporting regulatory operations for Middle East, Africa, Russia, CIS markets & Turkey in Merck Healthcare KGaA, Before Merck, Dr. George was leading international markets RA team in one of top leading pharmaceutical companies in Egypt.

Holding a bachelor’s degree in pharmaceutical science from Ain Shams university (2005) & Master of business administration from ESLSCS business school (2019).

Dr. George Has more than 17 years of experience within pharmaceutical industry in regulatory affairs and business development in different international markets.

Dr. Fatima Zaid Abu Zanat is an aspirational, committed, and experienced Regulatory Affairs/Quality Assurance (RA/ QA) professional with total of 17 years’ experience, with more than 12 RA/QA years in medical device, pharmaceutical and biotech industry across emerging markets with solid scientific background in product research/ development. Significant, strategic management exposure, where she is keen on developing optimum organization through performing periodical assessments, leading transformational changes, and developing best practices across the borders.

She was recently, professionally awarded the GCC Regulatory Affairs Award 2023 for the achievement “Woman of the Middle East” . She holds RAPS Dual Regulatory Affairs Diploma and Certificate (RAC Dual) in Medical Devices/Pharmaceuticals in addition to MSc in Pharmaceutical Technology. She is an active member in regulatory working groups within regulatory associations such as RAPS MENA local networking group as well as industry associations such as PhRMA MEA and formerly MECOMED. She is a licensed Basic Life Support Giver by American Heart Association and Licensed Specialist Pharmacist by UAE Ministry of Health and Jordan Food and Drug Administration.

She successfully established and managed multiple, UAE Scientific Offices for regional headquarters of emerging markets within Dubai, UAE; enabling organic/in-organic business growth. She built strong, direct channels with key, regional health authorities for continuous, shaping of the industry. She is experienced with development and management of teams on regional and global levels.

International publications:

• RAPS E-BOOK: F.Z. ABU– ZANAT(2022). Section IV postauthorization commitments and studies: Chapter 18 Middle East and North Africa. In L.M. and P.T (Ed.). Postapproval Changes for Drugs: A Practical Guide (pp. 209 – 212). RAPS.
• RP– LC Analysis Article: F.Z. ABU– ZANAT(2012). Ibuprofen Determination in Aqueous Solutions and Biological Samples. MedLab Magazine, 2012 (1): 36 – 42.
• Research Article: F.Z. ABU– ZANAT et al(2011). A Promising Codrug of Nicotinic Acid and Ibuprofen for Managing Dyslipidemia. I: Synthesis and In Vitro Evaluation. Drug Development and Industrial Pharmacy, 37 (9): 1090 – 1099.

Honors and awards:

• GCC Regulatory Affairs Award – 2023: For the achievement “Woman of the Middle East”.
• Women of Ipsen Nomination – 2022: One of 68 nominated Women of Ipsen for 2022 and the only one from META region.
• DUPHAT 2012 – 3rd Best Professional Poster Award: Professional Poster and Oral Presentation entitled “Synthesis and Evaluation of Nicotinic Acid and Ibuprofen Codrug for Managing Dyslipidemia by Newly Developed and Validated HPLC Method”, based on MSc Pharmaceutical Technology thesis dissertation.

Dr. Kurdi earned her PhD Degree in Biopharmaceutical Science in 2015 from University of Greenwich in UK.

Dr. Kurdi is currently working as Regulatory Affairs & Public Policy Director for EMEA Region at USP. USP is a non-Profit non-Governmental Organization with mission of assuring Quality of Medicines. Main responsibilities are to engage with USP Stakeholders, mainly National Regulatory Authorities, National Control Laboratories, International Organization like WHO, Pharmaceutical Association, Drug Policy Makers with topics and initiatives related to Heath and Quality.

Dr. Kurdi has over 30 years of experience in pharmaceutical industry in Quality Control, Quality Assurance, Research and Development, Regulatory Affairs, Commercial and Business Development including Technology Transfer (TT) as well licensing activities. Dr Kurdi held executive and management position during her work with Pharmaceutical Industry.

Additionally, Dr. Kurdi served as a member with more than committee with Jordanian FDA and international; With United State Pharmacopeia as an expert in the advisory panels of General Chapter (1197) and with International Generic and Biosimilar Medicine Association (IGBA) member in Biosimilar Committee.

Dr. Kurdi has many research papers published in Scientific Journals and she is frequent speaker in Pharmaceutical Conferences.

Kent Briggs is the Managing Director at VECTOR Life Sciences. He began working with eSubmissions in 2002 and eCTDs when they were first implemented in 2003. He has provided industry workshops in the US, Canada, Europe, South Africa, India and Australia and has performed application compilation training with both big and small pharmaceutical companies around the world. In addition to performing evaluator training at over 20 health authorities, Kent has authored the eCTD specifications for 4 regions including the soon to be released specifications for ECOWAS. Since 2014, Kent has focused on the CTD in Africa and supporting the harmonization efforts through regional and continental activities.

VECTOR Life Sciences is a service provider for the African regulatory market with a key focus on the implementation and usage of electronic systems to improve regulatory efficiency. VECTOR supports customers in their transition from paper based methods to electronic processes by streamlining their regulatory operations and making their use of data more effective

Susan Lin is a qualified pharmacist with a Bachelor of Pharmacy from Rhodes University with extensive experience in the healthcare industry.

Susan began her career in the public 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 Senior Manager: Heath Policy Development.

Her interests have been focused on the development of strategies for enabling access to pharmaceuticals and medical technologies. She is a passionate advocate of sustainable solutions in promoting access to innovative medicines in South Africa.

Susan has recently joined PATH as the Senior Analyst: Public Health Advisor, where she provides advice on Africa’s health research and development, medical countermeasures manufacturing, regulatory harmonization, public health system, pandemic preparedness and health security to inform policy actions.

After graduating from Faculty of Pharmacy-Ain Shams university, Haidy started her career at Egyptian Drug authority then joined Novartis CH as Head of regulatory for North Africa and Near East where she lead the regulatory function for English and French speaking Africa as well as LEVANT, in 2015 and as part of the Joint venture between Novartis and GSK Haidy joined GSK Consumer Healthcare leading the function within the same geography and now she is Director of regulatory affairs North, East and West Africa .She has a diversified experience across Africa and Near East in regulatory , pharmacovigilance and regulatory compliance while combining corporate and governmental legislative experience.

Visionary leader bringing over 30 years of experience in RA field by establishing big product portfolio in Egypt and over 70 export Countries at Middle East and Gulf Countries, Africa, Europe, Asian and CIS Countries. Ensuring company products are on track with updated regulations

Successful achievements in registering the first two Egyptian Sterile Pharmaceutical Products at WHO Prequalification Program.

I consider each dossier as a case to be filed for a court, challenging the whole process till we won the case

I am a painter, and this gives me a touch of creative expression as problem solving and thinking outside the box with high attention to details

Dr. Mona Mousa has a bachelor’s degree of pharmaceutical Science from the

faculty of pharmacy Ain Shams University (2007).

She had been working in the Egyptian Drug Authority over the Past fourteen years,

Within managerial positions as head of Human Pharmaceuticals Regulatory and Technical Affairs

Administrations since 2019 till end of 2022.

Prior to that she had been working as a regulatory specialist in different departments at EDA,

Including Registration files review, Scientific and Technical Committee departments.

In addition to her experience as a pricing specialist and as an EDA Inspector.

Currently and since January 2023,

She is Regulatory Affairs Associate Director at Hikma – Egypt.

Inas is a holder of Pharmacy diploma, and Master in EU and International Regulations and Healthcare Laws from Paris V University.

Inas has 20 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 EFPIA and PhRMA association groups for 6 consecutive years, and actively participating as speaker in regional and international conferences.

EDUCATION:

–     B.Sc. of Pharmaceutical science – Alexandria University, 1988.

• Business Administration & Marketing Certificate (AUC) 1994

• Health Economics – VSCR (Vienna School for Clinical Research ) 2008

• Total Quality Management for Health care (AUC) Jan-2012

Joined Egypt Health Authority for 2 years after graduation as registration officer

Worked as regulatory officer for MUP (Egyptian pharmaceutical company –Egypt)

In 1992 Moved to multinational German company (Madaus / Rotta pharm/ Viatris pharma) as medical representative, then different function has been added to her responsibility as planning & production coordinator, Marketing, sales supervisor, till became Deputy General Manager

In 1999 Moved to Eli –Lilly working as Regulatory & Corporate affairs Manager and Quality for Egypt, Sudan & Libya

In 2013 joined the newly established research-based company AbbVie with enthusiasm to patient centric team

At the same time I am active with different pharmaceutical associations in Middle East, chairing RWG for pharma in Egypt for 10 years.

Support & coordinate pharmaceutical Industry & health authority to shape the regulatory environment in Egypt. Partnership with Health authority for capability building programs to support patients for better access & affordable medication.

Active Member of organizing committee of MERC 2015 & 2017, 2019, 2020 (virtual) and 2023.

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.”

Regulatory Affairs expert with 14 years of solid Regulatory Affairs background in the pharmaceutical industry.

Profile and Areas of Expertise:

Experienced in developing different regulatory strategies in-line with business needs, leading registration, and lifecycle maintenance plans. In addition to safety management, compliance, SOPs design and audit readiness. Managed different lifecycle stages of an organization (merger, integration, and spin-off).

Drive interactions with Health Authorities, influence regulatory reforms and shape the external regulatory environment and health care policies.

Aspired to drive processes enhancements (Lean Six Sigma green belt certified). Have led and been a team member of different successful cross-functional projects including but not limited to New Product Launches, CMC and Ancillary component management, Safety management and Digital transformation in pharmaceutical industry.

Respect and leverage human capital – Motivate, coach, mentor and lead talented professionals helping teams to reach high integrated performance.

Position: Africa Cluster Manager – GSK

Lead Regulatory team for defined markets in relevant Cluster within EM organization as well as providing operational support including oversight and coordination of the operational matrix across Content Delivery, Region and Regulatory Third (3rd) Party Partners.

In my previous role within GSK Egypt, I served as Senior Regulatory Affairs manager, Planning and organizing the business goals, designing strategies to advance those goals. provide regular and constructive feedback, resolve problems and conflicts positively. Keep an eye on the regulatory environmental changes Develop effective and systemic approaches to regulatory intelligence, analyze relevant intelligence findings and communicate impact in an efficient format that facilitates awareness of business critical issues. I have a diversified experience across Pharma, Vaccine, Maintain governance and compliance, Internal control Frame work and business development.

I hold a bachelor’s degree of pharmaceutical science, a master’s degree of business administration in SMEs (Small and medium business enterprises) from the Arab Academy for Science, technology & Maritime transport.

Dr. Donia Fady is the RA Head at Takeda Pharmaceutical, Egypt

with 17+ years of experience in the pharmaceutical field, Donia has a proven track of record in regulatory strategic management utilizing strategic enterprise thinking and strong leadership skills. combining governmental and pharmaceutical companies’ experiences with strong Pharmacovigilance and QMS background.

Dr. Donia holds Bachelor’s degree of Pharmacy – Faculty of Pharmacy-Cairo university

Reham Alassily occupies the role of Associate Director Regulatory Affairs for Near East, Middle East & Africa at IQVIA heading the regional Regulatory Affairs Hub.  Reham is armed with an extensive background of 15+ years in the field of regulatory affairs and has occupied several leading roles in key multinational companies managing wide range of portfolios (Biological, Pharmaceutical ,Consumer health and Medical devices). In her current role at IQVIA, She is supporting several companies across diverse geographics to achieve business growth via establishing solid regulatory strategies.