Overview
As a direct and sole result of the outbreak of the coronavirus disease (COVID-19) and due to circumstances beyond our control, DIA has decided to change the format of the upcoming Advertising and Promotion Regulatory Affairs Conference from "face-to-face" (in-person) to entirely virtual.
For more information, please review the list of Frequently Asked Questions
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. Representatives from across FDA’s Medical Product Offices will provide the latest information on guidance policies, enforcement actions, and future directions of industry hot topics such as pre-approval activities, labeling strategies, and social media tactics.
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, combo products and companion diagnostics. Attendees 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.
Featured
Short Course or Primer
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May 17, 2020
Drug and Medical Device Ad Promo Primer
Learn more
Who should attend?
Professionals in pharmaceutical, biologics, and medical device companies involved in:
- Regulatory Affairs
- Marketing
- Communications
- Compliance
- Medical Information and Affairs
- Legal
- Senior Management
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 pharmaceuticals, biologics, generics, biosimilars, and medical devices
- Describe how other companies are interpreting policies and applying them to their current marketing strategies
- Recognize the differences between US FDA and other international regulatory policies regarding the promotion and advertising of medical devices
- 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 • Senior Director, Regulatory Affairs - Advertising, Promotions, and Labeling
Turning Point Therapeutics, Inc., A Bristol Myers Squibb Company, United States -
Kimberly Belsky, MS • Executive Director Reg Policy & Intell, AdPromo, RegOps, Regulatory Affairs
Mallinckrodt Pharmaceuticals, United States -
Glenn N. Byrd, MBA • President
GByrd Ad-Promo Solutions, LLC, United States -
Dale Cooke, JD, MA • President
PhillyCooke Consulting , United States -
Mark Gaydos • Vice President & Global Head, Advertising, Promotion & Labeling
Sanofi, 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 • Vice President, Specialty Compliance
Johnson & Johnson, United States -
Victoria Tamarkin, MS • Founding Partner & President, Global Regulatory Affairs, Promotional Compliance
Victoria Tamarkin Consulting LLC, United States -
Thomas W. Abrams, MBA, RPh • Retired, Director, Office of Prescription Drug Promotion, OMP, CDER
Former FDA, United States -
Wayne Pines • President, Health Care
APCO Worldwide Inc., United States -
Lucy Rose, MBA • President
Lucy Rose and Associates, United States
Contact us
Registration Questions?
Preconference Primer
Drug and Medical Device Ad Promo Primer
On Demand Content Preview Webinar
Ad/Promo eCTD Submissions Round Table
Additional Information
Advertising and Promotion Regulatory Affairs Resource Kit
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