Harvard-MIT Center for Regulatory Science转发了
?? Unraveling the Complexities of U.S. Pharmaceutical Regulations! I had an incredible time attending an insightful session hosted by the Harvard-MIT Center for Regulatory Science, on "Discover the Fundamentals of U.S. Pharmaceutical Regulation." The session was led by Brigid Bondoc, who provided a deep dive into key regulatory pathways and compliance aspects. She covered crucial topics, including: ? U.S. FDA Regulations & Regulatory Exclusivities ? NDA Submissions: 505(b)(1) & 505(b)(2) Pathways ? Fundamentals of Biologics Regulations under Section 351 of the PHSA ? Patent & Regulatory Strategies for pharmaceutical products A huge thank you to Monica Ruse, Program Director at the Harvard-MIT Center for Regulatory Sciences, for organizing such a seamless and insightful event! It was a truly enriching experience that helped me understand the intricacies of regulatory frameworks governing biologics and pharmaceutical products. I am excited to apply this knowledge to my journey in regulatory affairs! ?? #RegulatoryAffairs #FDA #PharmaceuticalRegulations #Biologics #HealthcareInnovation #Compliance #DrugDevelopment #HarvardMIT #LifelongLearningHarvardMedicalSchool #ProfessionalDevelopment