Back to Agenda
Disease State and Unbranded Materials - Regulatory Challenges
Session Chair(s)
Thomas M. Casola, MBA
Head, Global Regulatory Affairs, Advertising and Promotion
Shire Specialty Pharmaceuticals, United States
Companies are increasingly using disease state and unbranded materials including the creation of websites. These materials pose nuanced regulatory issues such as when does a company’s disease or unbranded website become promotional in nature and how can a company use such websites in conjunction with product promotion. What if disease state and unbranded materials go beyond approved labeling? This session will also address use of disease state materials during the pre-approval stage.
Speaker(s)
Presenters
Michael S. Labson, JD
Covington & Burling LLP, United States
Partner
Presenters
Glenn N. Byrd, MBA
GByrd Ad-Promo Solutions, LLC, United States
President
Presenters
Bryant Lim, JD
Viropharma Incorporated, United States
Associate General Counsel
Have an account?