Activities

FDAAAIN at 2nd DIA African Regulatory Conference March 2-3, 2010 Johannesburg, South Africa

Dr. Ekopimo (Imo) Ibia, one of the founding members of FDA Alumni Association International Network (FDAAAIN) planning group, participated as an invited speaker at the 2nd Drug Information Association African Regulatory Conference on March 3, 2010. This conference was co-sponsored by DIA and by the Southern African Development Community (SADC). The Africa Regulatory Network, an ad hoc regional network of EFPIA-International Regulatory Affairs Group, acted as the program committee. Dr. Ibia spoke about the unique contributions FDAAAIN may provide to regulatory authorities through shared learnings about regulatory operations and programs. He also provided his views about regulatory issues facing African health authorities. This is FDAAAIN’s first activity in Africa. Participants expressed interest in seizing the shared learning opportunities that FDAAAIN may offer.

The key focus of the conference was access to safe, effective, and quality medicines in the region. The conference presented opportunity to:

  • Foster collaboration between African regulators and the pharmaceutical industry,
  • Share information and best practices and workable solutions meeting the needs of the region for building regulatory capacity and streamlining regulatory processes,
  • Openly discuss issues facing African regulatory authorities and industry.

 

The main topics of the conference included:

  • Regulatory harmonization to improve access to medicines, with presentation of status updates on the ongoing projects under the African Medicines Registration Harmonization Initiative (AMRI). This Initiative is run by the New Partnership for African Development (NEPAD) and the Pan-African Parliament, in partnership with World Health Organization, and funded by Bill and Melinda Gates Foundation, the William J. Clinton Foundation, and the UK Department for International Aid. AMRHI is currently evaluating harmonization projects within four regional economic blocks.
  • Impact of changes in the global regulatory environment on Africa. African regulators were informed of regulatory trends in the European Union as well as opportunities to leverage the ICH process through the Global Cooperation Group.
  • The role of research and development in patient access to medicines with discussion of (1) opportunities and challenges that biologics present as well as a description of the current status of the science and manufacturing process of biologic; (2) one company’s efforts at addressing neglected diseases; (3) the regulatory considerations for biosimilars based on the EU and WHO regulatory pathways.
  • Regulatory challenges to access with focus on (1) building adequate capacity and leveraging expertise from organizations like FDAAA (2) enhancing speed to market and (3) management of variations.
  • Ensuring patient safety through the establishment of effective pharmacovigilance systems.
  • Updates on product quality, including GMP, manufacturing site inspections, and anti-counterfeiting strategies.

 

 

2nd African Regulatory Conference, Johannesburg, South Africa, March 2-3, 2010

Top Row: Group photograph of a cross section of speakers and organizers

Middle Row Left: Conference Chairperson, Professor Trevor Jones, CBE, Kings College, London, UK

Middle Row Right: Dr. Ekopimo Ibia, Director, Merck & Co., Inc., Member FDAAA

Bottom Row (L-R): Paul Orhii, MD, JD, Director General, National Agency for Food and Drug Administration and Controls (NAFDAC), Nigeria; Dr. Ekopimo Ibia, Director, Merck & Co., Inc., Member FDAAA; Dr. Truus Janse-de Hoog, Staff Member Medicines Evaluation Board, European Cluster; Chair of Coordination Group for Mutual Recognition and Decentralization Procedures - Human (CMD(h)), The Netherlands; Ms. Delese Mimi Darko, Head, Drug Evaluation & Registration, Food and Drug Board, Ghana; Ms. Florence Roizard, Director, Regulatory Affairs, Middle East and Africa, Merck Sharp & Dohme, France; and Ms. Kirti Narsai, Head, Scientific and Regulatory Affairs, Pharmaceutical Industry Association of South Africa (PIASA)