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Overview

March 11: Primer
March 12-13: Forum


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.



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 Director Regulatory Affairs, Advertising and Promotion
    Neurocrine Biosciences, Inc., United States
  • Kimberly  Belsky, MS
    Kimberly Belsky, MS Head of Regulatory Policy & Intelligence, Regulatory Affairs
    Mallinckrodt Pharmaceuticals, United States
  • Glenn N. Byrd, MBA, RAC
    Glenn N. Byrd, MBA, RAC 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 VP, NA General Medicines/US Advertising and Promotion, Global Regulatory Affairs
    Sanofi, United States
  • Joanne S Hawana, JD, MS
    Joanne S Hawana, JD, MS Member
    Mintz Levin, United States
  • Mary L Raber  Johnson, PhD, RAC
    Mary L Raber Johnson, PhD, RAC Assistant Professor, Clinical
    The Ohio State UniversityCollege of Pharmacy, United States
  • Kevin M Madagan
    Kevin M Madagan Partner
    Reed Smith, LLP, United States
  • Sheetal  Patel, PharmD
    Sheetal Patel, PharmD Head, Regulatory Advertising and Promotion
    Johnson & Johnson International, United States
  • Victoria  Tamarkin, MS
    Victoria Tamarkin, MS Founder and Principal, Regulatory Compliance, Advertising and Promotion
    Victoria Tamarkin Consulting LLC, United States
  • Thomas W. Abrams, MBA, RPh
    Thomas W. Abrams, MBA, RPh Director, Office of Prescription Drug Promotion, OMP, CDER
    FDA, United States
  • Wayne L. Pines
    Wayne L. Pines President, Regulatory Services and Healthcare
    APCO Worldwide Inc., United States
  • Lucy  Rose, MBA
    Lucy Rose, MBA President
    Lucy Rose and Associates, LLC, United States
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Contact us

Registration Questions?

Send Email
1.888.257.6457


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