How to Strengthen Capacity in Africa for the Registration of New Drugs for Neglected Diseases? That was the topic discussed by more than 50 attendees at the workshop which was held during DNDi‘s 2nd Stakeholders’ and 3rd African Meetings, in Nairobi, Kenya.
The workshop looked into present regulatory approaches and mechanisms, how they interact with each other and what are the advantages and disadvantages of each in supporting the registration process in Africa. Several case studies with different registration strategies were presented to inform the broader discussion. The workshop’s aim was to identify the best regulatory approach to enable, in Africa, the registration of new chemical entities.
1. Pharmaceutical registration in Africa – Meeting new challenges
by Javier Guzman on behalf of Mary Moran, George Institute for International Health
2. Comments on the report on Pharmaceutical Regulatory in Africa
by Hiiti B. Sillo, Tanzania Food and Drug Authority
3. European Procedures
by Matthias Dormeyer, expert in European regulatory systems
4. Lessons learnt from the registration of paromomycin in India
by Philippe Desjeux & Louise Johnson, Institute for One World Health
5. Lessons learnt from the registration of ASAQ
by Mireille Cayreyre, sanofi-aventis
6. DNDi needs: future registration of fexinidazole for human African trypanosomiasis and of paromomycin for visceral leishmaniasis in Africa
by Els Torreele & Manica Balasegaram, DNDi