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Making Comments Count: Best Practices in Developing Comments for a Global Audience

Track:
Public Policy/Health Care Compliance/Law

Day & Time:
June 18, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:
366

Room Number:
16A

Level:
Intermediate

Type:
Workshop

Title:
Making Comments Count: Best Practices in Developing Comments for a Global Audience

Chair(s):
Linda F. Bowen, MS, RAC
Head, US Regulatory Policy and Intelligence
Sanofi US, United States

Description:
In this workshop, we will share best practices in the development of comments, which gives industry an opportunity to influence regulatory authority thinking during an open consultation period.

**Due to workshop format, seating will be limited and will be available on a first come, first served basis.

The San Diego Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this offering will not be recorded.

Learning Objective(s):
Identify opportunities for participation in the commenting/consultation process; Share best practices in the development of comments on official regulatory documents; Demonstrate the value of participating in the commenting process.

Presentation(s) & Speaker(s):
Facilitator
Kimberly Belsky, MS
Executive Director, AdPromo, Labeling and Policy
Valeant Pharmaceuticals, United States

Facilitator
Amy N. Grant, MS
Director
HBG Memorial Fund, United States