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1st Regional Conference on Regulatory Harmonisation


Speakers

  • Dounia   El Maimouni

    Dounia El Maimouni

    • JANSSEN, France

    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

    Hany Gamal

    • Regional Drug Regulatory Affairs Head, Middle East, Turkey & Africa
    • Boehringer Ingelheim, United Arab Emirates

  • Nevena  Miletic

    Nevena Miletic

    • PDR - International Regulatory Policy
    • F. Hoffmann-La Roche Ltd, Switzerland

    Nevena is a Regulatory Policy Lead for Eastern Europe, Middle East and Africa region in the F.Hoffmann-La Roche Ltd. Global Regulatory Policy group.She has fifteen years of experience in pharmaceutical industry, mostly in the areas of Policy, Regulatory Affairs, Quality Assurance, Pricing and Market Access, and Marketing. Before joining Global Regulatory Policy in F. Hoffmann-La Roche, Switzerland, she was heading Roche affiliate Regulatory Affairs, Quality and Pricing department in Serbia, and was also deeply involved in healthcare policy creation, legislation changes and close collaboration with different stakeholders in Serbian healthcare system. In addition, she was heading INOVIA’s (member of EFPIA) Regulatory Affairs Working Group.

  • Myriam  Sedrati

    Myriam Sedrati

    • Regulatory Affairs Director North and West Africa
    • Merck Sharp & Dohme, Morocco

    Myriam Sedrati serves as Regulatory Affairs Director for North West Africa and Responsible Pharmacist at MSD Morocco. Myriam spent 22 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. Myriam is member of Africa Regulatory Network in IFPMA (International Federation of Pharmaceutical Manufacturers & Associations). Myriam is Doctorate in Pharmacy from University René Descartes Paris V - France.

  • Anne  Grandjacquot

    Anne Grandjacquot

    • Head of Regulatory Affairs - Africa Region
    • Sanofi, 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  Bernat

    Janis Bernat

    • Scientific Assistant
    • IFPMA, Switzerland

  • Bouchra  Essaoui

    Bouchra Essaoui

    • DRA Head
    • Novartis Pharma Maroc SA, Morocco

  • Oumkaltoum   Lahlou

    Oumkaltoum Lahlou

    • Head of Regulatory Affairs North & West Africa
    • Merck, Tunisia

    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  Ubaysi

    Kamal Ubaysi

    • Global Head of Integration projects
    • Sanofi, France

    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.

  • Samvel  Azatyan, MD, PhD

    Samvel Azatyan, MD, PhD

    • Group Lead, Regulatory Networks and Harmonization (RNH/RSS)
    • World Health Organization (WHO), Switzerland

    Dr Samvel Azatyan is a pediatrician with a Ph.D. degree in clinical pharmacology and medical products regulation. Dr Azatyan has joined the World Health Organization in 1999 and is currently leading the Regulatory Networks and Harmonization Group in the Regulatory Systems Strengthening Team within the Department of Essential Medicines and Health Products at the World Health Organization's Headquarters, Geneva, Switzerland.

  • Sameh  Ben Tkhayat

    Sameh Ben Tkhayat

    • Expert Coordinator in Biosimilar Committee
    • Direction De La Pharmacie, Tunisia

    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.

  • Lotfi   Benbahmed

    Lotfi Benbahmed

    • President
    • National Order of Pharmacists of Algeria, Algeria

  • Fabio  Bisordi, MSc

    Fabio Bisordi, MSc

    • Global Head International Regulatory Policy
    • F. Hoffmann-La Roche Ltd., Switzerland

    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.

  • Omar  Bouazza

    Omar Bouazza

    • Director
    • Direction du Médicament et de la Pharmacie, Morocco

  • Meriem  El Beghdadi

    Meriem El Beghdadi

    • Head of Visas, Homologations and Authorizations
    • Direction Du Médicament Et De La Pharmacie, Morocco

    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

    Mick Foy

    • Head of Pharmacovigilance Strategy, Vigilance Intelligence and Research Group
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

    Mick has been with the MHRA’s Vigilance Intelligence and Research Group for 9 years. Amongst his responsibilities is the operation of the UK’s Yellow Card Scheme and the MHRA’s signal detection systems. He is also responsible for two large European projects to improve drug safety monitoring. The EC funded SCOPE (Strengthening Collaborations to Operate Pharmacovigilance in Europe) Joint Action aims to improve the pharmacovigilance capabilities of national regulators in Europe, and the Innovative Medicines Initiative funded WEB-RADR (Recognising Adverse Drug Reactions) project seeks to deliver mobile Apps for reporting ADRs and to utilise social media for drug safety purposes.

  • Ines  Fradi

    Ines Fradi

    • Head of Pharmacy and Medicines
    • Ministry of Health, Tunisia

    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  Gulphe

    Catherine Gulphe

    • Sanofi-Synthelabo, France

    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  Haouach

    Imane Haouach

    • Head of Quality Assurance
    • Laboratoire National De Contrôle Du Médicament, Morocco

    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.

  • Mearal  Hussein

    Mearal Hussein

    • Head of Regulatory Middle East
    • GSK Consumer Health, Egypt

  • Mustapha  Laaroussi

    Mustapha Laaroussi

    • President
    • National Order of Pharmacists, Tunisia

  • Wiame  Lakhlili

    Wiame Lakhlili

    • Pharmacist Assessor
    • Laboratoire National De Contrôle Du Médicament, Morocco

    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   Lumsden

    Rebecca Lumsden

    • Director – EM Regulatory Policy
    • Pfizer Ltd, United Kingdom

    Rebecca is Regulatory Policy lead for Emerging Markets in the Pfizer Essential Health Global Regulatory Policy Group. Her focus areas are biosimilars and anti-infectives in AFME, Latam & APAC. 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 member of the Regulatory Policy and Technical Standards Committee in IFPMA and FIFARMA’s Regulatory and Biologics Working Group. She was a post-doctoral scientist prior to pursuing a career in policy, with a PhD from the University of Cambridge (UK) in cancer cell signalling and a BSc, in Biochemistry from the University Of Bristol (UK).

  • Djoubeir  Makhlouf

    Djoubeir Makhlouf

    • Regional Head of International Pharmacovigilance - EEMEA
    • F. Hoffmann-La Roche Ltd, Switzerland

    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  Motaouakkil

    Saadia Motaouakkil

    • President
    • Regional Council of Pharmacists of South, Morocco

    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  Mouani

    Mhammed Mouani

    • Deputy Head of the Biological Assays Laboratory
    • Laboratoire National De Contrôle Du Médicament, Morocco

    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  Paulino

    Ema Paulino

    • Interim CEO
    • International Pharmaceutical Federation (FIP), Netherlands

    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  Sellam, PharmD, PhD

    Yacine Sellam, PharmD, PhD

    • Assistant General Manager
    • Pasteur Institute of Algeria, Algeria

    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 - Ministry of Health. He is Second Secretary of the Algerian Society of Pharmacy, Board Member of the Algerian Society of Regulatory Affairs & Pharmacoeconomics, and Regulatory Advisor to Algeria’s Ministry of Health. Yacine holds the position of Assistant General Director in charge of Vaccines & Sera Development Projects at Pasteur Institute of Algeria. He is Expert Member of the National Immunization Technical Advisory Committee.

  • Rachida  Soulaymani-Benchei

    Rachida Soulaymani-Benchei

    • Centre Anti Poison Et De Pharmacovigilance Du Maroc, Morocco

    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 Kiptum Tanui, MBA, RPh

    Paul Kiptum Tanui, MBA, RPh

    • Senior Programme Officer, African Medicines Regulatory Harmonization Programme
    • The New Partnership For Africa's Development (NEPAD), South Africa

    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.

  • Klara  Tiitso, MSc

    Klara Tiitso, MSc

    • Scientific Administrator
    • European Medicines Agency, United Kingdom

  • Kowid  Ho, PharmD

    Kowid Ho, PharmD

    • Pharma Technical Regulatory Policy
    • F. Hoffmann-La Roche Ltd, Switzerland

    Kowid Ho has been working at F. Hoffmann-La Roche Ltd.’s Global Pharma Technical (CMC) Regulatory Policy in Basel, Switzerland for 4 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.

  • Riadh  Daghfous

    Riadh Daghfous

    • Head of Pharmacovigilance
    • Centre National de Pharmacovigilance, Tunisia

    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.