Overview
Primer: March 5
Conference: March 8-10
DIA’s Advertising and Promotion Regulatory Affairs Conference explores the current state of compliance for marketing both biopharmaceuticals and medical devices. Join thought leaders from industry, legal, public affairs, and government for interactive and compelling discussions that will shape policy and define strategic priorities within the advertising and promotion regulatory space.
This conference is geared towards both early and late-career professionals with content that advances the understanding of current regulatory policies, details the latest strategies for effective patient engagement, and discusses the trends in advertising for biopharmaceuticals, combination products, and companion diagnostics. You will have the opportunity to network with key thought leaders from the FDA, industry, and other regulatory practitioners, while simultaneously discussing the challenges and opportunities of marketing pharmaceuticals and medical devices today.
Who should attend?
- Regulatory Affairs
- Marketing
- Communications
- Compliance
- Medical Information and Affairs
- Legal
- Patient Engagement
Learning objectives
- Discuss the latest FDA policies, guidances, and how they apply on a practical basis to day to day oversight of advertising and promotional materials for biopharmaceuticals and medical products
- Describe how other companies are interpreting policies and applying them to their current marketing strategies
- Evaluate risk and identify mitigation strategies associated with virtual medical promotion and online marketing tools
- Apply the latest policies to better communicate with all audiences, including payers
- Select and implement effective digital and social media strategies to meet the challenges of ensuring compliance with FDA regulatory requirements
Program Committee
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Micheline Awad, MBA • Director Regulatory Affairs, Advertising and Promotion
Neurocrine Biosciences, Inc., United States -
Kimberly Belsky, MS • Executive Director Regulatory Policy & Intelligence and Labeling Operations, Reg
Mallinckrodt Pharmaceuticals, United States -
Carla Brooks, MSc, RAC • Senior Director, Regulatory Affairs, Advertising and Promotion
Blueprint Medicines Corporation, United States -
Dale Cooke, JD, MA • President
PhillyCooke Consulting , United States -
Virginia Foley • Principal Consultant
Opus Regulatory Inc, United States -
Catherine Gray, PharmD • Acting Director, Office of Prescription Drug Promotion, OMP, CDER
FDA, United States -
Joanne Hawana, JD, MS • Member
Mintz, Levin, Cohn, Ferris, Glovsky & Popeo P.C., United States -
Mary L Raber Johnson, PhD, RAC • Assistant Professor - Clinical
The Ohio State University, College of Pharmacy, United States -
Kevin Madagan, JD • Partner
Reed Smith, LLP, United States -
Sheetal Patel, PharmD • Head, Regulatory Advertising and Promotion
Johnson & Johnson International, United States -
Victoria Tamarkin, MS • Founding Partner & President, Global Regulatory Affairs, Promotional Compliance
Victoria Tamarkin Consulting LLC, United States -
Mark Gaydos • Vice President, US Advertising & Promotion, Global Regulatory Affairs
United States -
Wayne Pines • President, Health Care
APCO Worldwide Inc., United States -
Lucy Rose, MBA • President
Lucy Rose and Associates, LLC, United States
