Dounia El Maimouni holds a MSc in Microbiology & Biotechnology from University of Paris 11 – Orsay (France). She is currently Regional Regulatory Affairs Manager for Near East, Maghreb & Africa (NEMA) at Janssen Pharmaceutical companies of J&J. Dounia has 8 years’ experience in Regulatory Affairs in non-EU Markets, and has been working on various therapeutic areas (Immunology, Oncology, Diabetes, Infectious Diseases) She is a member of African Regulatory Network in IFPMA (International Federation of Pharmaceutical Manufacturers & Associations) and also member of LEEM French association.

Hany Gamal, a qualified pharmacist and MBA graduate, currently appointed as the Regional Head of Regulatory Affairs Department at Boehringer Ingelheim Middle East, Turkey and Africa; services a very diversified region known for its turbulent yet very promising business environment. With expertise that range over 28 years in the industry within the Commercial, Marketing and Regulatory Affairs functions; he has excelled in the ability to create and use every opportunity to improve the life of patients. In his area of focus, he advocates that the welfare of patients will only be established through a robust and transparent collaboration between the countries’ regulatory authorities and the industry.

Nevena Miletic is a pharmacist, with postgraduate studies in parmacoeconomics, Reg Affairs and QA, with more than 18 years of experience in pharma industry. Currently she works in Global Regulatory Policy at F. Hoffmann-La Roche and for the last five years, she is co-chairing IFPMA Africa Regulatory Network and CPP Network. She is also a member of IFPMA Regulatory Science and Africa Engagement Committees, DIA MEA Advisory Board, EFPIA ERAO PI WG, IATF etc., being involved in numerous projects with regulators and cross-industry collaborative platforms (e.g. Pre-ICDRA, ICDRA, IMI, SCoMRA etc.). Nevena is a strong advocate for regulatory convergence and harmonisation, with main interest in innovative approaches in drug development and review.

Myriam Sedrati serves as Regulatory Affairs Director for North West Africa and Responsible Pharmacist at MSD Morocco. She spent 23 years of experience at the pharmaceutical industry in Europe, Middle East Africa region in 3 different pharmaceutical companies. Her professional career spans a number of roles in quality assurance, manufacturing operations, regulatory Affairs, market access in the pharmaceutical sector. She is also a member of Africa Regulatory Network in IFPMA (International Federation of Pharmaceutical Manufacturers & Associations). Myriam has a Doctorate in Pharmacy from University René Descartes Paris V - France.

Anne is a pharmacist, has a master in galenic and a degree in pharmacology from University of Paris XI- Châtenay-Malabry (France). She is Global Regulatory Affairs Africa Region Head at Sanofi. Anne has 16 years’ experience in Regulatory Affairs in EU and non EU markets and has been working on various therapeutic areas (Oncology, Diabetes, generics, CHC) at regional level and at sanofi French affiliate. Anne has been deputy of the quality person several times during her career. She has also been responsible of pharmaceutical development in central nervous system area for 7 years. She is a member of Africa Regulatory Network in IFPMA (International Federation of Pharmaceutical Manufacturers & Associations) and also member of LEEM.

Janis leads cross-functional activities in regulatory science and international health policy for IFPMA, while partnering with policy experts and stakeholders to strengthen the pharmaceutical regulatory environment. She is responsible for guiding the organization’s regulatory team to successfully deliver its policy objectives and advocate for improved regulatory system strengthening. Prior to joining IFPMA, Janis worked in quality assurance and regulatory compliance for a US-based multinational company specializing in food service and retail. Janis holds a Master of Science in Communication-Public Relations and a Bachelor of Science in Agriculture-Food Science.

Kaltoum is a pharmacist and has a Master in Compliance in Pharmaceutical Industry from the University of Barcelona, Spain. She is actually Head of Regulatory Affairs of North and West Africa region at Merck since 2013. She worked 8 years at Bayer in Barcelona then in Casablanca in different positions: Quality Assurance, Industrial Development manager department before joining the Regulatory department. She is a member of Africa Regulatory Network in IFPMA and is also member of the local trade association in Morocco : LEMM ( Les Entreprises du Medicament au Maroc).

Kamal started his career with L’Oréal & Wella Cosmetics. He joined GlaxoSmithKline where he held different management roles before taking GM Consumer Health for North & Central Africa. In 2007, Kamal joins Sanofi. In 2014, he is given the responsibility to lead the Commercial & Operations Support CHC across AMESA region (Africa, Middle East and Eurasia) providing support to Operations and local teams. At the integration of Boehringer Ingelheim Consumer in 2017, Kamal was appointed Lead Integration Head. In 2016, Middle East, North Africa Self Medication Industry was formed, and Kamal was elected Chairman of this association.

Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration, convergence and harmonization, as well as regulatory capacity building and facilitation of products introduction in the countries. Dr Azatyan has also led various projects aiming at development of national regulatory systems, as well as the development and implementation of the concept of reliance in regulation of medical products. Dr Azatyan is currently leading the Regulatory Convergence and Networks Team at the WHO's Headquarters in Geneva, Switzerland.

Sameh is a licensed pharmacist in charge of drug registrations, clinical trials at the Pharmacy and Medicines Unit, Tunisian Ministry of Health since 2015. She graduated from University of Pharmacy in Tunisia with Pharm.D degree as well a Master degree in quality management for health sector. She was a Quality Assurance Officer at the Arab Company of Pharmaceutical Industries (SAIPH). She collaborated in the guidance review for drug registrations in Tunisia released in May 2016 and was the project leader of the Bioequivalence Guidance in Tunisia released in January 2017. She participated in the preparation of the Tunisian Guideline Draft of biosimilars and she is currently the coordinator of Biosimilar Committee formed in April 2017.

Fabio is Head of the International Regulatory Policy group at Roche. He has over 18 years’ experience of working within Global Regulatory Affairs. Fabio started his regulatory career at Cyton Biosciences Ltd., and then joined Chiron Vaccines as Senior Regulatory Affairs Manager. He joined Roche in 2005 where he led the Global Regulatory activities for biologics, before joining the Biologic Strategy Team as Global Biosimilar Regulatory Franchise Head. He has contributed and managed global regulatory projects and has engaged in a variety of interactions with Health Authorities globally. He represents Roche in various EFPIA, IFPMA and EBE-biotech working groups. He is currently Vice-chair of the EBE Biotherapeutics Working group.

Meriem ELBEGHDADI est le chef de services des visas homologations et autorisations à la direction de médicament et de la pharmacie - Ministère de la Santé - Maroc. Meriem a passé 24 ans d’expériences à la direction de médicament et de la pharmacie - Maroc Sa carrière professionnelle couvre un certain nombre de rôles dans l’évaluation des dossiers, la réglementation pharmaceutique, la pharmacovigilance, l’inspection pharmaceutique et le secretariat des commissions d’AMM, des commissions des essais cliniques et des commissions de publicité des médicaments. Meriem est docteur en pharmacie de la faculté de médecine et de pharmacie de Rabat - Maroc.

Mick Foy has been with the MHRA for more than 35 years, he is a member of the MHRA’s Executive Committee and has recently been appointed Director of Delivery . Amongst his responsibilities is to drive initiatives to introduce new and improved services to stakeholders. Mick is SRO for the SafetyConnect and RegulatoryConnect programmes. He also leads MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation.

Ines Fradi is Pharm. D from the Faculty of Pharmacy of Monastir University, Tunisia, M.Sc. and Ph. D in pharmaceutical and biomedical sciences from University of Liège (Belgium). She is Professor of analytical chemistry in the faculty of Pharmacy of Monastir. She is specialist in hospital pharmacy from the Rene Descartes University Paris V (France) and specialist in hospital and industrial pharmacy, from the Faculty of Pharmacy of Monastir. After working as hospital pharmacist in Charles Nicole Hospital she joined the National Drug Control Laboratory as assessor of marketing authorization applications. She was advisor to the Minister of Health. Actually, she is Director of Pharmacy and Medicines Unit at the Ministry of Health

Catherine is a pharmacist and has a Ph D in Analytical Chemistry from Paris XI University, France. She was a laboratory manager for 15 years in Analytical Sciences Development within Sanofi Research and Development prior to join the Regulatory Affairs Department in 2004.

Imane is Head of Quality Assurance service for Medicines Assessment at the National Laboratory of Medicines Control of the Directorate of Medicines and Pharmacy (DMP)- Ministry of Health of Morocco. She has an experience of 23 years at the Directorate of Medicines and Pharmacy and she is pharmacist inspector; performed the various inspection of the pharmaceutical structures regarding the Moroccan regulation.Imane has a university degree in biomedical research from the Faculty of Medicine and Pharmacy in the Mohammed V University of Rabat and she is Doctor of Pharmacy from University Granada in Spain.

Wiame is a Pharmacist assessor in the Quality Assurance service for Medicines assessment at the National Laboratory for Medicines Control of Directorate of medicines and Pharmacy – Ministry of Health of Morocco. She is in charge of the assessment of medicines specially Biologics and biosimilars for Marketing authorization. She graduated in 2012 from the Faculty of Medicine and Pharmacy in the Mohammed V University of Rabat, the Master's degree in Medical Biotechnology in the field of bioinformatics, molecular model and molecular docking for kinases. In 2017, she obtained her National Doctorate (PhD) in Drug Science, from the Faculty of Medicine and Pharmacy-Mohammed V University of Rabat. Wiame is pharmacist inspector.

Rebecca is a Director in the Pfizer Global Regulatory Policy and Intelligence group. Focus areas include expedited and reliance approval pathways, regulatory system strengthening and evolving standards of evidence especially in International regions. Prior to joining Pfizer in 2017, she was Head of Science Policy at the UK Trade Association (ABPI) and has worked on numerous policy issues relevant to the biopharmaceutical industry during her 8 years there. She is a Co-Chair of the FIFARMA’s Regulatory and Biologics Working Group and a member of the Expedited Pathways group in EFPIA. She was a post-doctoral scientist prior to her career in policy, with a PhD from Fitzwilliam College, University of Cambridge (UK) in cell signalling.

Djoubeir holds a Doctorate of Pharmacy from Paris XI University with a major in International Development and Registration of Medicinal Products. He is currently the Interim head of International Pharmacovigilance for the Eastern Europe, Middle East and Africa Region (EEMEA) at Roche. He possess more than 13 years of Pharmacovigilance experience in various pharmaceutical industries in different countries. This includes Pfizer and Pierre-Fabre in France, Roche in Algeria, Switzerland and Genentech in US. His diverse career Journey fostered his in depth knowledge of the European, US PV legislation and EEMEA countries’ Health Authorities regulations.

Saadia has a 25 years of experience in community pharmacy and she has a PhD in pharmacy obtained at Université de Haute Bretagne I from Rennes, France.

Mhammed is Deputy Head of the Biological Assays Laboratory at the National Laboratory for Medicines Control of the Directorate of medicines and Pharmacy – Ministry of Health of Morocco and he is Head of Biotechnology Unit with 14 years of experience in the control of biological drugs. He is a pharmacist inspector and performed the various inspection of the pharmaceutical structures (pharmaceutical companies, wholesale distributors, community and hospital pharmacies). Mhammed is Doctor in pharmacy and he graduated in 2012 at the Faculty of Medicine and Pharmacy in the Mohammed V University of Rabat, the Master's degree in Medical Biotechnology.

Ema is a practising community pharmacist at her own pharmacy in Portugal, and currently accountable for the development and implementation of pharmaceutical services in a network of 400 independent pharmacies. She is President of the Lisbon and South Branch of the Portuguese Pharmaceutical Society and a member of its National Board and represents this organisation at the Pharmaceutical Group of the European Union and the International Pharmaceutical Federation (FIP). Previously, she was a member of the Board of the National Association of Pharmacies. Currently Interim CEO and Professional Secretary of FIP, Ema was previously Chairperson and Project Coordinator of the Young Pharmacists' Group, and Secretary of the Community Pharmacy Section.

Yacine acted as Regulatory Evaluator of drugs registration dossiers, and as Permanent Secretary of the Economic Inter-Ministerial Committee in charge of Drugs Pricing at the General Directorate of Pharmacy and Health Equipment of Ministry of Health. He is President of the Algerian Society of Regulatory Affairs & Pharmacoeconomics, Assistant General Director in charge of Partnerships at Pasteur Institute of Algeria, a public non-profit health organization, and Expert Member of the National Immunization Technical Advisory Committee. Yacine is also Associate Professor and Scientific Board Member at Pharmacy Faculty of Algiers. He has been keynote Speaker and Panelist across various healthcare regional and international congresses.

Rachida is Director at the Centre Anti Poison et de Pharmacovigilance du Maroc, Ministry of Health Rabat Morocco. She is also Clinical Pharmacology Professor at the University of Pharmacy and Medicine, Rabat, Morocco. Rachida is also Director at Morocco WHO Collaborating Centre for Strengthening Pharmacovigilance Practices, Rabat and supports WHO with normative functions, pharmacovigilance systems and centres, patient safety in francophone, eastern Mediterranean and Arabic countries. She has Medical Doctor degree from Faculté de Medecine et de Pharmacie Rabat Morocco and a master in Fundamental and Clinical pharmacology from Faculté de Medecine Montpellier France.

Paul Tanui is currently Senior Programme Officer – Technical Support for African Medicines Regulatory Harmonisation (AMRH) Programme – a programme coordinated by the African Union (AU)/New Partnership for Africa’s Development (NEPAD) Planning and Coordinating Agency. Paul is a pharmacist by profession and holds postgraduate qualifications in Business and Healthcare Management. He has over 14 years of experience gained mainly in pharmaceutical regulatory affairs and quality assurance.

Kowid Ho has been working at F. Hoffmann-La Roche Ltd.’s Global Pharma Technical (CMC) Regulatory Policy in Basel, Switzerland for >10 years. He was previously a quality assessor for biological products at Agence nationale de sécurité du médicament et des produits santé (ANSM, formely AFSSaPS) for 13 years. He has authored many European assessment reports and scientific advices on biotech, vaccines, blood and advanced therapy products, and has participated to several product related inspections. He was a member of European Medicines Agency (EMA) Biologics Working Party (BWP), Biosimilar Working Party (BMWP), and PAT/QbD team.

Professor Riadh is the General Manager of the Tunisian National Centre of Pharmacovigilance. Doctor in Medicine since 1988, Professor Riadh received the title of Resident Physician for Hospitals of Paris and the Master’s degree in biological and medical studies (university of Paris Val-de-Marne). He’s a member of the Technical Committee of Pharmaceutical Specialities and the Technical Committee of Vaccines Control. He has been Secretary General of the Tunisian Society of Geratology. He represented Tunisia at WHO for the international network and surveillance of pre-qualified vaccines. He’s a founder of the African Society of Pharmacovigilance and a member of the International Society of Pharmacovigilance.