DR. ONESMO MPANJU (REGIONAL HEAD – USA AND EASTERN & CENTRAL AFRICA)
Dr. ONESMO MPANJU is a biopharmaceutical consultant and regulatory scientist with over 25 years experience in the development and regulation of biopharmaceuticals in markets as diverse as the United States, Canada, European Union, Asia-Pacific and Africa.Dr. Mpanju has worked for world renowned companies such as UCB Pharma, British Columbia Centre for Excellence in HIV/AIDS, Viridae Clinical Research, National Cancer Institute – Frederick and PPD. Dr. Mpanju was a Reviewer at the U.S. FDA, Center for Biologics Evaluation & Research. He has worked for eight years as Director Global Regulatory Affairs and Director Regulatory Consulting for PPD.Dr. Mpanju key practice areas includes clinical trial compliance, marketing application regulatory strategy formulation, preparation of submission dossiers, orphan drug applications in the U.S. and E.U., interaction with regulatory authorities, due diligence audits for asset acquisition, contract manufacturing organization (CMO) sourcing and management, and compliance with current good manufacturing practices (cGMPs).