Biotherapeutic Medicines Workshop on Pharmacovigilance for Biotherapeutic Medicines: Pre & Post-Approval Settings

11 September 2015 George Walker Bush Highway, North Dzorwulu, Accra, Ghana PMB 163 Cantonments, Accra

11 September 2015


9:00 to 16:00


George Walker Bush Highway, North Dzorwulu, Accra, Ghana PMB 163 Cantonments, Accra


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The region-wide workshop has brought together more than 50 individuals representing academia, regulatory authorities, government officials and industry to share their experiences and technical expertise on the application of pharmacovigilance (PV) systems for biotherapeutic medicines in the stages prior and post regulatory approval locally and globally. The event was organized by International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in collaboration with Food and Drugs Authority (FDA) of Ghana and World Health Organization’s Collaborating Centre for Advocacy and Training at the University of Ghana. The event begun with a welcoming speech from the CEO of FDA of Ghana, and continued with presentations by representatives from National Agency for Food and Drug Administration and Control (NAFDAC), West African Health Organization (WAHO), and several representative specialists in the areas of regulatory and public policy from some of the leading pharmaceutical producers, who joined on behalf of IFPMA (F. Hoffmann-La Roche Ltd., Janssen, Novartis International AG).


9:00 - 9:10

Welcome by Mr. Hudu Mogtari,
CEO, Ghana Food & Drugs Authority

9:10 - 9:15

Introduction to the workshop by Janis Bernat,
Associate Director, Biotherapeutics & Scientific Affairs at IFPMA

9:15 - 10:30

Pharmacovigilance in the Pre-approval Setting (Chair: Alex Dodoo, WHO CC; Co-Chair: Nevena Miletic, IFPMA)
Session 1:
Elements of a Risk Management Plan (RMP)
1. Alex Dodoo, Director, WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance

10:30 - 10:45

Coffee Break

10:45 - 12:00

RMP Issues & Challenges: NRA & Industry Perspectives
Session 2 (30 min presentation & 15 min Q&A):
1. Helga Nosiri, Assistant Director, Pharmacovigilance/Post Marketing Surveillance (PV/PMS) Directorate, National Agency For Food and Drug Administration and Control (NAFDAC)
2. IFPMA – Nevena Miletic, Regulatory Policy Lead (Roche)

13:00 - 14:45

Pharmacovigilance in the Post-approval Setting Chair: Delese Darko, Ghana FDA Co-Chair: Karin Heidenreich, IFPMA
Session 3:
Regulatory Assessment & “Noncomparable Biotherapeutics”: Regional/National Regulatory Authority & Industry Perspectives
1. Sybil Nana Ama Ossei-Agyeman-Yeboah, Professional Officer in Charge, Essential Medicines and Vaccines, West African Health Organisation
2. Delese Darko, AG. Deputy Chief Executive, Safety Monitoring & Clinical Trials Division Ghana Food & Drugs Authority
3. IFPMA – Karin Heidenreich, Public Policy R&D (Novartis)

14:45 - 15:00

Coffee Break

15:00 - 15:45

Interactive Panel Discussion
Moderator: Lorenz Scheppler (Janssen, IFPMA)
Session 4: Panel Discussion and Q&A
Participants: Chairs, Co-Chairs & Speakers

15:45 - 16:00

Wrap-up & closing of the workshop, summary of main outcomes.
Session Chairs: Alexander Dodoo & Delese Darko


Hudu Mogtari Chief Executive Officer (CEO), Food and Drugs Authority (FDA) of Ghana

Hudu is the Chief Executive Officer (CEO) of the Food and Drugs Authority (FDA) of Ghana. He holds an Executive Master of Business Administration (MBA) degree from the Ghana Institute of Management and Public Administration (GIMPA) and a Bachelor of Science in Pharmacy (BSc Pharm) from the University of Hacettepe in Ankara, Turkey. He was awarded a Certificate in Strategic Management in Regulatory and Enforcement Agencies (SMREA) at the Harvard Kennedy School of Government. He also has training in Clinical Investigation by the Centre for Drug Evaluation and Research (CDER) of the United States Food and Drugs Administration (USFDA), advanced training in Diabetes and Endocrinology at the Centre for Diabetes and Endocrinology in South Africa as well as training at the United States Pharmacopoeia (USP) in USA. Mr. Hudu has over 20 years’ experience as a pharmacist and he was the country manager for Eli Lilly prior to his appointment as the Chief Executive of the FDA. Under his leadership the FDA has achieved ISO 17025 accreditation for its Drugs Physico-Chemical Laboratory. The FDA has also been designated as a Regional Centre of Regulatory Excellence (RCORE) in the area of Medicines Evaluation and Registration as well as Clinical Trials Oversight.

Alexander Dodoo Director, WHO Collaborating Centre for Advocacy and Training at the University of Ghana

Alexander Dodoo (PhD, FPSGH, FPCPharm, FGCPharm) is an Associate Professor at the Centre for Tropical Clinical Pharmacology, School of Medicine and Dentistry, University of Ghana as well as the Director of the WHO Collaborating Centre for Advocacy and Training at the University of Ghana. He serves on several local and international advisory, training and safety committees, including Member, WHO Advisory Committee on the Safety of Medicinal Products; Member, Access & Product Management Advisory Committee of the Medicines for Malaria Venture and Chairman of the Strategic Planning Group of the Global Vaccine Safety Initiative. He was for two terms (4 years), the President of the Pharmaceutical Society of Ghana and served as President of the Pharmacy Information Section of the International Pharmaceutical Federation. From 2009 – 2012, Alex Dodoo served as the President of the International Society of Pharmacovigilance (ISoP) after which he now remains on the Executive Committee of ISoP as Past President. He is the author/co-author of various manuscripts and full papers in peer-reviewed journals and has one book published titled: Healthy Secrets – a layperson’s guide to health issues.

Helga Nosiri Assistant Director Pharmacovigilance/Post Marketing Surveillance Directorate, National Agency for Food and Drug Administration and Control (NAFDAC)

Helga Mbakwe Nosiri is a Pharmacist with over 23 years’ experience in various fields including Pharmacovigilance and Community Pharmacy. She has worked in the United States as a Retail Pharmacist in CVS-College Park, GA, Jack Eckerd Corporation-Douglasville, GA, Drug Emporium-Macon, GA, Rite Aid Pharmacy-Green Belt, MD and Shoppers Drug Mart-Toronto, Canada.
Helga is also a seasoned Substance Abuse Specialist, Sponsor and Educationist and is Alumnus, St. Jude’s Atlanta, Atlanta, GA-an inpatient and outpatient recovery facility which imbibes the 12 step program and is an Ambassador for Narcotics Anonymous and Alcoholics Anonymous for over 12 years.
She currently works for the National Agency for Food and Drug Administration and Control (NAFDAC), Abuja, Nigeria as an Assistant Director (AD)-PV/PMS Directorate and is the Head of Pharmacovigilance.

Nevena Miletic Regulatory Policy Lead, F. Hoffmann-La Roche Ltd.

Nevena Miletic, MPharm, is Regulatory Policy Lead for EEMEA region in F. Hoffmann-La Roche, Switzerland. She has worked within the pharmaceutical industry for more than twelve years, through different positions with increasing responsibility, mostly in areas of Regulatory Affairs and Quality Management.
Before joining Global Regulatory Policy in F. Hoffmann-La Roche, Switzerland, she was heading Roche affiliate Regulatory Affairs and Quality department in Serbia, and was also deeply involved in healthcare policy creation, legislation changes and close collaboration with different stakeholders in Serbian healthcare system. Since end 2013 she was also heading INOVIA’s (local industry association, member of EFPIA) Regulatory Affairs Working Group and chairing Biotherapeutics Working Group, was closely involved in discussions related to EU accession and medicines regulations harmonization process on behalf of industry; she is initiator of establishing proposal of renewed CADREAC-like procedure for EU candidate countries (including Serbia). Nevena Miletic is also member of IFPMA Africa Regulatory Network, IFPMA CPP Network, as well as EFPIA Russian Network.
Nevena Miletic obtained her MPharm from the University of Belgrade (Faculty of Pharmacy), Republic of Serbia, and is currently finalizing QP specialization on the same Faculty.

Delese Darko Ag. DCE Safety Monitoring & Clinical Trials Division, Food and Drugs Authority Ghana

Mrs. Delese Darko is the Deputy Chief Executive in charge of Safety Monitoring and Clinical Trials Division of the Food and Drugs Authority (FDA), Ghana. She is a pharmacist with over 24 years’ experience in regulation of medicines and a Chief Regulatory Officer and holds a Master in Business Administration.
Mrs. Darko has served on several local and international advisory committees, she is currently the Secretary to the two Technical Advisory Committees of the FDA, member of the CIOMS Vaccine Safety Committee, Member, Technical Advisory Group on Malaria Vaccines Decision Making Framework, Global Vaccines Safety Initiative, African Vaccines Regulatory Network Forum AVAREF and many others. She has chaired and made presentations on the regulation of medicines, vaccines and biotherapeutics, clinical trials and pharmacovigilance in various national and international conferences and workshops.
She authored several scientific abstracts in the area of pharmacovigilance, which are published in journals including The Drug Safety Journal, the official journal of the International Society of Pharmacovigilance.

Karin Heidenreich Director Public Policy R&D, Novartis International AG

Dr. Karin Heidenreich is Director Public Policy R&D with Novartis International AG in Switzerland. In her function she advocates – amongst other topics – the corporate Novartis policy on biosimilars in working groups of various pharmaceutical trade associations, such as IFPMA and EBE, as well as in discussions with international organizations, like WHO and EMA.
Karin has been working with Novartis for many years in different functions in Clinical Research, Drug Regulatory Affairs and Public Affairs in Germany, Belgium and Switzerland.
Karin holds a diploma and PhD in biology from the Diabetes Research Centre at the Heinrich-Heine-University of Dusseldorf in Germany. She also has a master degree in Drug Regulatory Affairs of the Friedrich-Wilhelm-University of Bonn, Germany.

Sybil Nana Ama Osssei-Agyeman-Yeboah Professional Office in Charge Essential Medicines and Vaccines, West African Health Organization (WAHO)

Mrs. OSSEI-AGYEMAN-YEBOAH Sybil Nana Ama, a Pharmacist, Pharmaceutical and Quality Assurance Analyst and the Professional Officer in charge of Essential Medicines and Vaccines at the West African Health Organization in Bobo-Dioulasso, Burkina Faso. She is also a Licensed Administrative and Management Consultant. Her current job deals greatly in the development of regional harmonization of policies, legislations, regulations and guidelines, capacity building to create local experts to strengthen the human resource job force in the Economic Community of West African States (ECOWAS). Collaborate, coordinate and cooperate with various partners and stakeholders both regionally and internationally to put technical, financial and know-how together to enhance the public health interventions to improve the healthcare of the population in the region. Such interventions are functioned in the priority strategies through strengthening of the capacity of pharmaceutical production of medical products, quality control laboratories, the fight against counterfeit and illicit trade in medicines, strengthening of National Medicines Regulatory Authorities capacities, pharmacovigilance, safety and medicines information services, vaccines, immunisations and emergency epidemics situations, regional approach for the implementation of WTO TRIPs flexibilities to improve medicines accessibility and enhancing the supply chain and distribution systems. These are all intended to improve the accessibility of essential medicines and vaccines to the population in the ECOWAS region.

Lorenz Scheppler Director Global Regulatory Affairs in the Infectious Diseases and Vaccines Therapeutic Area, Janssen

Dr. Lorenz Scheppler is currently Director, Global Regulatory Affairs, in the Janssen Infectious Diseases and Vaccines Therapeutic Area in Leiden, The Netherlands. In his role as a Global Regulatory Leader he is responsible for the overall regulatory support for the development of several development vaccines.
He has been working for many years in the Biotech industry where he was involved in the research, development and maintenance of several biotherapeutic products and vaccines. He launched his career in a mid-sized Swiss biotech company before joining Janssen Infectious Diseases and Vaccines (formerly Crucell) in 2008. He also serves as the company’s representative in the IFPMA biotherapeutics group.
Dr Scheppler holds a PhD in Immunology & Allergology and a Master of Science in Medical Microbiology from the University of Bern, Switzerland.

Janis Bernat Associate Director, Biotherapeutics & Scientific Affairs, IFPMA

Janis Bernat joined IFPMA in 2006 to work with the Vaccines Committee and Influenza Vaccine Supply Task Force. She is currently responsible for the policy and technical work in the area of biotherapeutic and biosimilar medicines and leads the organization’s regulatory team. Janis holds degrees in agriculture, food science, and mass communications from several US universities. Prior to joining IFPMA, she worked for a US-based multi-national food company in quality assurance and regulatory compliance