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Effective Communication Model Between Drug Safety, Regulatory Affairs, and Clinical Development

Track:
Clinical Safety and Pharmacovigilance

Day & Time:
June 16, 11:00AM - 12:30PM (Pacific Standard Time)

Session Number:
140

Room Number:
6E

Level:
Intermediate

Type:
Session

Title:
Effective Communication Model Between Drug Safety, Regulatory Affairs, and Clinical Development

Chair(s):
Thomas Felix, MD
Director, Research and Development Policy
Amgen Inc., United States

Description:
This session reviews ideal interactions between regulatory affairs, safety, and clinical development in order to avoid noncompliance. Effective communication between safety, regulatory affairs, and clinical is key to address issues arising during development and postapproval.

Learning Objective(s):
Discuss the development and implementation of an effective communication model between drug safety, regulatory affairs, and clinical development; Discuss establishing communication channels prospectively to address safety and regulatory issues during development and postapproval labeling updates when there are different marketing authorization holders in different territories.

Presentation(s) & Speaker(s):
An Ideal Model to Avoid Non-Compliance
Firoz Nilam, MS
President
Nilam Pharmaceutical Consulting Inc., United States

How to Optimize Safety Interactions and Collaborations
Mariette Boerstoel-Streefland, MD, MBA, MS
Head, Global Safety and Pharmacovigilance
Baxter International Inc. , United States

Regulatory Affairs Department Short Falls and Resolutions Towards the Ideal Model
Thomas Felix, MD
Director, Research and Development Policy
Amgen Inc., United States