2024 NCRAF Pharm/Bio Workshop

If you have questions about this course please contact rac_workshops@ncraf.org

Course Details

Q&A Session Schedule
2024 Q&A
Chaper 1: Introduction
FDA Overview by Maria Oyaski
Regulatory Authority Meetings by Kevin Barber
CMC by Timothy Reinhardt
Chapter 2: Early Development
Nonclinical Development and GLPs by Brenda Faiola
GCP by David Jensen
Clinical Protocols by Ben Vaughn and Jamie Chang
Combination Products by Judy Hauser
Chapter 3: Regulatory Procedural
IND-CTA-CTx by Karl Whitney
Peds & Orphan Products by Nasrin Habibi
Marketing Applications by Sheila Plant
Chapter 4: Specific Product Types
Pharmaceuticals by Catherine Maher
Biologics and Biosimilars by Maria Oyaski
Advanced Medicinal Therapeutic Products by Maria Oyaski
Chapter 5: Late Development
Pharmacovigilance by Lisa Hornick
Product Labeling by Joseph Watson
Compliance and Inspections by Drew Barlow
Post-Marketing by Karin McIntosh
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