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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.


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Continuing Education

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Highlights & Features

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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

At the end of this conference participants should be able to:
  • 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

  • Micheline  Awad, MBA
    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
    Kimberly Belsky, MS Executive Director Reg Policy & Intell, AdPromo, RegOps, Regulatory Affairs
    Mallinckrodt Pharmaceuticals, United States
  • Glenn N. Byrd, MBA
    Glenn N. Byrd, MBA President
    GByrd Ad-Promo Solutions, LLC, United States
  • Dale  Cooke, JD, MA
    Dale Cooke, JD, MA President
    PhillyCooke Consulting , United States
  • Mark  Gaydos
    Mark Gaydos Vice President & Global Head, Advertising, Promotion & Labeling
    Sanofi, United States
  • Joanne  Hawana, JD, MS
    Joanne Hawana, JD, MS Member
    Mintz, Levin, Cohn, Ferris, Glovsky & Popeo P.C., United States
  • Mary L Raber  Johnson, PhD, RAC
    Mary L Raber Johnson, PhD, RAC Assistant Professor - Clinical
    The Ohio State University, College of Pharmacy, United States
  • Kevin  Madagan, JD
    Kevin Madagan, JD Partner
    Reed Smith, LLP, United States
  • Sheetal  Patel, PharmD
    Sheetal Patel, PharmD Vice President, Specialty Compliance
    Johnson & Johnson, United States
  • Victoria  Tamarkin, MS
    Victoria Tamarkin, MS Founding Partner & President, Global Regulatory Affairs, Promotional Compliance
    Victoria Tamarkin Consulting LLC, United States
  • Thomas W. Abrams, MBA, RPh
    Thomas W. Abrams, MBA, RPh Retired, Director, Office of Prescription Drug Promotion, OMP, CDER
    Former FDA, United States
  • Wayne  Pines
    Wayne Pines President, Health Care
    APCO Worldwide Inc., United States
  • Lucy  Rose, MBA
    Lucy Rose, MBA President
    Lucy Rose and Associates, United States
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