2023 NCRAF Pharm/Bio Workshop

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

Course Details

2023 Syllabus
2023 *Current* Syllabus
Introduction
FDA Overview by Maria Oyaski
Nonclinical Development and GLPs
Nonclinical Development and GLPs by Brenda Faiola
Good Clinical Practice
GCP by David Jensen
Combination Products
Combination Products by Judy Hauser
Chemistry, Manufacturing, and Controls (CMC)
CMC by Timothy Reinhardt
Clinical Protocols and Clinical Development Plans
Clinical Protocols by Ben Vaughn and Jamie Chang
IND-CTA-CTx
IND-CTA-CTx by Karl Whitney
Pediatric, Orphan Product and Expanded Access Development for Rare Diseases
Peds & Orphan Products by Nasrin Habibi
Regulatory Authority Meetings
Regulatory Authority Meetings by Kevin Barber
Biologics and Biosimilars
Biologics and Biosimilars by Maria Oyaski
Pharmaceuticals
Pharmaceuticals by Catherine Maher
Marketing Applications
Marketing Applications by Sheila Plant
Advanced Medicinal Therapeutic Products
Advanced Medicinal Therapeutic Products by Maria Oyaski
Pharmacovigilence
Pharmacovigilence by Lisa Hornick
Compliance and Inspections
Compliance and Inspections by Drew Barlow
Post-Marketing
Post-Marketing by Karin McIntosh
Product Labeling
Product Labeling by Joseph Watson
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