FDAAA Sponsors Session on Clinical Research Enterprise in Africa, Asia, and South American at 50th US DIA Annual Meeting

During the 50^th US DIA Annual Meeting on June 16-19, 2014 in San Diego, CA, the FDA Alumni Association (FDAAA) through its International Network (FDAAAIN) sponsored a session titled Strengthening Public Policy for Sustainable Clinical Research Enterprise in Africa, Asia, and South America: Progress and Prospects.

The session examined some of the evolving policies and initiatives about clinical research in the three regions with the aim that participants could identify potential opportunities to locate clinical trials in these regions. Specifically, the session discussed ongoing activities to promote clinical research in Africa, Asia, and South America. The session also highlighted efforts at further strengthening the clinical research infrastructure in the regions.

Two FDAAAIN members participated on the session panel. Ekopimo Ibia, MD, MPH, FAAP (founding member of FDAAAIN and Director, Regulatory Affairs, Merck & Co., Inc.) chaired the session. Florence Houn, MD, MPH, FACP (FDAAAIN Co-chair and VP, Regulatory Affairs, Celgene Corporation) spoke on “APEC Regulatory Harmonization Steering Committee and Its Impact on Clinical Trials.” Dr. Houn presented a brief overview of clinical trial issues in Asia as well as some key activities of the APEC Regional Harmonization Steering Committee (RHSC) to promote clinical research in the region with particular emphasis on two of the five RHSC priority work areas: multiregional clinical trials and good review management.

Earlier in the session, Maria Joo Queiroz, DrMed (Global Chief Executive Officer, Eurotrials, Portugal) discussed the strengths and weaknesses of the clinical research environment in South America. She then described some recent pivotal public policies and initiatives in three of the key economies in the region, Brazil, Argentina, and Chile, all of which are pushing the innovation agenda with renewed vigor.

Rounding up the session, Thomas Nyirenda MD, MS (Manager, Networking and Capacity Development, European & Developing Countries Clinical Trials Partnership (EDCTP), South Africa) described the clinical trial environment in Africa with a review of trials in poverty related diseases (specifically HIV and malaria). He then discussed the clinical trial capacity in the region, which segued to discussing the EDCTP activities and accomplishments in promoting clinical research in the region.

The session attracted robust audience participation with most of the questions directed at policies and initiatives to strengthen clinical trial environment in Africa.