Dr. Nigel A.S. Hernandez is a global regulatory science expert and frequent speaker with over 16+ years experience in food, drugs, biologics, devices and combination products in over 40 countries. Dr. Hernandez is currently completing a post-doctorate as a Director of Global Regulatory Science in urology products at a Pharmaceutical company in the Philadelphia area, and serves as Chief of Regulatory Science/ Quality at GloboFruit LLC ((website hidden)). Dr. Hernandez is a founder of the Center for the Study of Regulatory Affairs, Inc. ((website hidden)) and serves as an Associate Professor at University of Maryland (MBA Capstone course: Marketing and Strategy Management in the Global Marketplace). Dr. Hernandez was previously on the faculties of West Virginia University and Northeastern University.
Dr. Hernandez received his Doctoral degree in International Biomedical Regulations and Regulatory Science, MSc. in Regulatory Science for Food, Drugs, Biologics & Medical Devices, and Graduate Certificates in Medical Devices Regulatory Affairs (EU, US, Japan) and Biopharmaceutical International Regulatory Affairs at Northeastern University. He attended Boston University (MS, Advertising) and Edinburgh Business School (MBA). He is a graduate of Syracuse University (BA/BS), Regulatory Affairs Certified, Regulatory Affairs Board Certification (RAC), Eudravigilance Certified by European Medicines Agency, and serves as a Qualified Person and Responsible Person for Pharmacoviligance.
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