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Primer: February 15, 2023

Conference: February 23-24, 2023

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 professional development, and discusses the trends in advertising for medical products. You will have the opportunity to network with key thought leaders from the FDA, industry, and other regulatory agencies, while simultaneously discussing the challenges and opportunities of marketing pharmaceuticals and medical devices today.

Participant Testimonials

"Very well-structured meeting. Great information about regulatory processes at FDA, and how we can access the team members there. It is all about building relationships, it is refreshing.” - Catherine Lair - Leadiant Biosciences

“The content was unique, thought provoking, and relevant. Many ad promo presentations are rehashing what we already know. This conference gave me new perspectives to consider.” - Kim Aubrey-Larcinese - CSL Behring

“The event was well organized and relevant to current topics within the industry. Additional speaker/participants from FDA were knowledgeable and enjoyed being able to interact with them in an informal way.” - Suzanne Bayreuther - Sunovion Pharmaceuticals


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Who should attend?

  • Meeting Designed For

    • Regulatory Affairs
    • Marketing
    • Communications
    • Compliance
    • Medical Information and Affairs
    • Legal
    • Patient Engagement
  • Learning Objectives

    At the conclusion of this activity, participants should be able to:
    • Recognize significant advertising and labeling concerns that each FDA medical product Center addresses
    • Discuss FDA’s expectations based on their draft guidance for Diversity & Inclusion in Clinical Trials
    • Apply lessons and recommendations to lead a successful inclusive, multicultural marketing campaign
    • List the different characteristics and skills sets to succeed within regulatory advertising and promotion
    • Apply communication and negotiation skills to accomplish goals and manage conflicts with other stakeholders
    • Recognize variations that exist when developing a global review process
    • Identify involvement opportunities within DIA AdPromo WG and learn about how to join!
    • Describe AI’s impact on AdPromo review and list the current AI tools to assist in AdPromo review
    • Outline the regulatory and statutory foundations of the concepts of promotion and scientific exchange
    • Apply measures to maintain the integrity of scientific exchange while avoiding the perception of promotion
    • Identify the risks and limitations of various social media platforms and recognize the impact influencers have on product promotion
    • Apply best practices for preparation and execution of media interviews
    • Identify best practices for implementing a label change
    • Discuss FDA’s draft guidance on Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products and the FDA-FTC Joint Statement Regarding a Collaboration to Advance Competition in the Biologic Marketplace
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Program Committee

  • Fadwa  Almanakly, PharmD
    Fadwa Almanakly, PharmD Vice President & Head, Advertising and Promotion, Regulatory Affairs Americas
    Bayer Pharmaceuticals, United States
  • Sheetal  Patel, PharmD
    Sheetal Patel, PharmD Vice President, Specialty Compliance
    Johnson & Johnson, United States
  • Heather  Banuelos, JD
    Heather Banuelos, JD Counsel
    King & Spalding LLP, United States
  • Kimberly  Belsky, MS
    Kimberly Belsky, MS Reg Policy & Intell and AdPromo, Regulatory Affairs
    Independent, United States
  • Bob  Dean, MBA
    Bob Dean, MBA Head of Global Labeling Strategy & Ad/Promo
    EMD Serono, United States
  • Virginia  Foley
    Virginia Foley Head of Marketing & Strategic Business Development Ad Promo - Practice Leader
    Opus Regulatory Inc, United States
  • Catherine  Gray, PharmD
    Catherine Gray, PharmD Director, Office of Prescription Drug Promotion, OMP, CDER
    FDA, United States
  • Georgina  Lee, PharmD
    Georgina Lee, PharmD Executive Director, Regulatory Advertising and Promotion
    Sage Therapeutics, 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
  • 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
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