Theme 1: Do current guidelines promote or constrain post-trial access to drugs, devices and vaccines?

Session co-chaired by Dr Malegapuru Makgoba (*)(MRC South Africa) and Mr Nick Winterton (MRC UK)

9:10 Plenary introduction: Dr Churchill Lukwiya Onen (Princess Marina Hospital, Gaborone, Botswana)

9:40 Presentation of two relevant case studies: Professor Ruth Macklin (Albert Einstein College of Medicine, USA)
- Case study 1: access to treatment following clinical trials: the case of a pneumococcal -conjugate vaccine trial in The Gambia
- Case study 2: what are researchers’ and institutions’ responsibilities to the study  community?

9:50 Break

10:10 Discussion of case studies in breakout groups

12:10 Report back from breakout groups in plenary session

13:00 Lunch

14:00 Keynote speech: Mr Doug Wassenaar (University of Natal, South Africa)

Theme 2: Creating a national framework for ethical research: what’s needed and how to go about it

Session co-chaired by Dr Godwin Ndossi (Tanzania Food & Nutrition Centre, Tanzania) and Professor Keith McAdam (MRC Laboratories, The Gambia)

14:30 Plenary introduction: Professor Godfrey Tangwa (University of Yaoundé, Cameroon)

15:00 Presentation of two relevant case studies: Professor Zulfiqar Ahmed Bhutta (Aga Khan University, Pakistan)
- Case study 3: obligations to third parties in the face of possible harm
- Case study 4: is community consent authentic and legitimate?

15:10 Break

15:30 Discussion of case studies in breakout groups

17:30 Report back from breakout groups in plenary session

18:20 End of session

20:00 Gala dinner in the hotel

OPAS Brazil