Overview
Conference: February 22-23 | In-Person
This conference explores the evolving regulatory landscape for advertising and promotion of biopharmaceuticals and medical devices, with a focus on innovation, compliance, and patient-centric communication.
Amid increased regulatory attention and new cross-agency initiatives focused on advertising and promotion, attendees will gain timely insights into how evolving policies are shaping compliance expectations across traditional, digital, and AI-driven channels. Session will address cutting-edge topics such as the application of artificial intelligence in promotional review, the practical application of the new Scientific Information on Unapproved Uses (SIUU) guidance, the integration of patient-reported outcomes (PROs) in labeling and communications consistent with labeling (CFL), and emerging trends in digital and social media promotion.
Join thought leaders from industry, legal, public affairs, and government for interactive discussions that will define strategic priorities, share best practices and provide actionable insights into regulatory expectations and real-world implementation.
Designed for professionals at all career stages, this conference offers a comprehensive understanding of current FDA policies, emerging trends in digital marketing and disease awareness campaigns, and practical tools for optimizing promotional review processes. Network with experts from the FDA, industry, and regulatory agencies to tackle the challenges and opportunities in today's fast-evolving advertising and promotion environment.
While we develop our 2027 agenda, please take a moment to review the 2026 Final Agenda.
Program Committee
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Janet Gottlieb, PhD Head of Medical Review Solutions
Canopy Life Sciences, United States -
Kristen Heinlein, PharmD Vice President, Advertising & Promotion Regulatory
Takeda, United States -
Mary Johnson Consultant
StratPhD LLC, United States -
Darshan Kulkarni, JD, PharmD, MS, RPh Principal Attorney
Kulkarni Law Firm, PC, United States -
John Paul Marcus, PharmD Executive Director, Regulatory Compliance
Ionis Pharmaceuticals, United States -
Twyla Mosey, PharmD Acting Office Director, OPDP, CDER
FDA, United States -
Joshua Oyster, JD Partner
Ropes & Gray, United States -
Gina L. Vestea, PharmD Head, Global Regulatory Affairs Advertising & Promotion
Sanofi, United States -
Heta Zaveri, PharmD, MBA Regulatory AdPromo Practice Leader
Opus Regulatory, United States
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