Track
:
Track 05: Regulation of Product Advertising and Marketing in an Ever-changing World
Program Code:
248
Date:
Tuesday, June 25, 2013
Time:
1:45 PM to 3:15 PM
EST
Location:
102AB
CHAIR
:
Michele L. Sharp, PharmD (SCHNON), Senior Director, Global Regulatory Affairs - US, Eli Lilly and Company, United States
Michele supervises regulatory reviewers who review all ad/promo materials for US marketed products. She develops mutually productive relationships with the FDA Office of Prescription Drug Promotion and drives the external advocacy agenda focused on topics that will improve outcomes for patients.
SPEAKER
(S):
Darshna Patel, (SPKNON), Director, Global Regulatory Affairs and Safety: Pipeline Product Labeling, Amgen Inc., United States
Darshna Patel, currently Director, Pipeline Product Labeling at Amgen, has 23 years of industry experience in Regulatory Affairs, Research, Development & Compliance. In her current role she facilitates development of target labeling & oversees the target labeling initiative in Regulatory Affairs.
Lynette Hopkinson, (SPKNON), Senior Director, Commercial Regulatory Afairs, Eisai Inc., United States
A Senior Director in Eisai's Global Regulatory Affairs Dept. heading up the Commercial Regulatory Affairs function including Global Labeling and the Copy Review Committees for the review and approval of all US product advertising and promotion materials. Received her BPharm in JHB, S. Africa.
Description
Many companies make development plans based on the shortest path to filing a marketing application. This may mean doing the minimum number of trials required to gain approval and designing trials to maximize the probability of gaining a positive clinical outcome. This panel will describe and discuss an alternative approach. By understanding the promotional claims necessary for successful commercialization before pivotal trials are initiated and by involving all the relevant regulatory disciplines in designing a development program, the probability of commercial success can be maximized.