This course was designed to promote professionalism in the clinical trial industry for individuals involved with FDA submissions (Investigational New Drug (IND) Application, New Drug Application (NDA), Biologic License Application (BLA), and Investigational Device Exemption (IDE)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical products.
Timestamps
01:30 - Chemistry, Manufacturing, and Controls: Requirements for Early Clinical Development
22:16 - Pharmacology & Toxicology Information to Support Early Drug Development
41:17 - Clinical Pharmacology: Early Drug Development
1:05:09 - Q&A Session 6
1:23:30 - Day Two Closing
Speakers:
Paresma Patel, PhD
Division Director
Division of New Drug API
Office of New Drug Products (ONDP)
Office of Pharmaceutical Quality (OPQ) | CDER | FDA
Matthew Thompson, PhD., MPH
Supervisory Pharmacologist
Division of Hematology Oncology Toxicology (DHOT)
Office of Oncologic Diseases (OOD)
Office of New Drugs (OND) CDER | FDA
Shirley K. Seo, PhD
Director
Division of Cardiometabolic and Endocrine Pharmacology (DCEP)
Office of Clinical Pharmacology (OCP)
Office of Translational Sciences (OTS) | CDER | FDA
Leonard Sacks, MBBCh
Associate Director
Office of Medical Policy (OMP) | CDER | FDA
Panelists:
Leonard Sacks, Paresma Patel, Matthew Thompson, and Shirley Seo
Learn more at: www.fda.gov/drugs/news-events...
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Upcoming Training - www.fda.gov/cdersbia
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Email - CDERSBIA@fda.hhs.gov
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13 дек 2022
