Amid high-profile pharmaceutical advertising and labeling controversies, the premiere membership society representing health product regulatory affairs professionals will gather leading industry, government and legal experts next month in Denver to discuss the marketing of drugs and medical devices.
The Advertising, Promotion and Labeling (APL) Conference, the Regulatory Affairs Professionals Society’s (RAPS) annual platform for discussing advertising and promotion of medical devices and prescription drugs and biologics, will take place 1-2 May at the Grand Hyatt Denver Downtown.
As the regulatory environment for device and drug advertising and promotion evolves under new FDA regulations, industry initiatives and multi- million dollar settlements, industry, government, and legal leaders will use APL to evaluate and plan for new iterations in the field, said RAPS Executive Director Sherry L. Keramidas, PhD, CAE.
The conference is a forum for diverse experts to lend insight into the latest regulations, guidelines and trends affecting the advertising and promotion of medical devices, drugs and biologics.
“Because of several recent hot-button issues, it is essential for industry regulatory affairs and marketing professionals to participate in this dialogue,” said Keramidas.
Keramidas said the conference will identify the concerns surrounding complex and rapidly shifting topics in regulatory advertising and promotion, such as off-label promotion and enforcement actions. She said attendees will also evaluate regulation applications through interactive case studies.
APL offers general sessions and two focused, tailored tracks, specific to prescription drugs/biologics or medical devices. This year, for the firs time, the conference will also feature an informal reception.
Featured speakers at APL include Laura Rich, Regulatory Counsel, Division of Drug Marketing, Advertising, and Communications, FDA, and Maryann Gallagher, Acting Branch Chief, Advertising and Promotional Labeling Branch, Division of Case Management, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, US Food and Drug Administration