Director, Vaccine, Vigilance and Clinical Trials Directorate, Food and Drugs Authority Ghana
Edwin Nkansah (PhD) is a 44-year-old Ghanaian Director, and Head of the Vaccines, Vigilance and Clinical Trials Directorate at the Food and Drugs Authority (FDA), Ghana. Prior to his current role, he was the founding Head of the Vaccines and Biological Products Department, the Department responsible for the regulatory oversight for Biological Products, including vaccines. His current scope of regulatory oversight includes the clinical trials, vaccine and biological products and safety monitoring regulatory functional areas. Edwin has been a regulatory officer since November 2012, He led the establishment of the Department and oversaw its progression from a Unit to a Department with the responsibility of establishment the basic regulatory framework for authorizing the use of biological products, including vaccines in Ghana. Edwin’s PhD was in Pharmaceutical and Biological Chemistry, specializing in molecular biology techniques and protein engineering, and a master’s degree in Drug Discovery, all degrees from the University College London School of Pharmacy.
He has been involved in 11 publications and abstracts. Prior to joining the FDA, Edwin was a full-time lecturer at the School of Pharmacy, University of Ghana. He retains a part-time role at the school with the Department of Pharmacology and Toxicology.
On the global front, Edwin has consulted for the World Health Organization (WHO) and has participated in the drafting of WHO guidelines, including the revision of the WHO Biosimilar guidelines, which was developed to provide guidance to manufacturers and regulators. Further, he was one of the primary drafters for the Marketing Authorization and Clinical Trials Oversight fact-sheets of the WHO Global Benchmarking tool (GBT), the tool used to evaluate the maturity of National Regulatory Authorities.