Femi Morakinyo Ph.D.
Regulatory Specialist
FACILITATOR: Day 2
PROFESSIONAL WORKSHOP: Regulatory Specialist
Dr. Femi is an experienced scientist and regulatory affairs professional providing expert support and hands-on strategies for medical products from ideation, trial/investigation, submission, to post-approval activities in line with Canadian & USFDA requirements. Previously while on the bench, he acted as principal investigator (PI) or co-principal investigator (co-PI) in over dozens of research projects and produced more than 40 refereed journal articles and conference publications.
Now in the industry and as a regulatory consultant, his expertise lies in the areas of preparing and/or reviewing applications, developing regulatory strategy as well as conducting regulatory assessment / gap analysis for new products including supplements/natural health products, food, drugs, and medical devices.
Femi possesses top-notch skills in helping sponsors follow Food and Drug Regulations and good clinical practices, conduct well-designed clinical trials, protect the health of the people in the trial and achieve the goals of the trial. Femi has given several presentations in both local and international conferences, workshops and seminars which have served as platforms for the transfer of ideas. He holds a Ph.D. from the University of Lagos Nigeria and postgraduate diploma in Regulatory Affairs from Humber College, Ontario Canada.
