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Bethesda North Marriott Hotel and Conference Center

Mar 08, 2018 7:00 AM - Mar 09, 2018 3:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Advertising and Promotion Regulatory Affairs Conference

Overview

March 7: Primer Course*
March 8-9: Conference

 *Primer requires separate registration.

DIA’s Advertising and Promotions (Ad Promo) Regulatory Affairs Conference offers a comprehensive agenda covering the latest updates in the ad promo regulatory space. Industry experts will share best practices for ad promo launch strategy, discuss global ad promo review considerations, and evaluate how clinical trial design impacts promotional practice. Hear from FDA on the latest OPDP draft guidance and initiatives, enforcement actions, social science research and electronic Common Technical Document (eCTD) submission process.

The conference delivers an overview of the current and future state of advertising and promotion, featuring perspectives from medical marketing agencies, regulatory, medical, and legal professionals. Whether you are new to the field or have years of experience, you can't afford to miss this opportunity to prepare yourself for what’s coming!

On-Demand Complimentary Webinar

Navigating the Still Murky Waters of Manufacturer Communications: Promotion, Commercial Speech, and Scientific Exchange
During this webinar we will examine how companies can proactively communicate outside the information expressly contained in a product’s approved full prescribing information and consider where companies might consider altering their traditional policies and where it may be prudent to continue exercising caution.
Register today!

Preconference Primer on Wednesday, March 7

  • Ad Promo Primer
    • If you are new, or relatively new, to the preparation or review of advertising and/or promotional materials, this primer is for you! This course is designed to provide background information for you to better understand the conference content. The leaders will provide an introductory foundation for anyone working in our current regulatory environment. Whether you are a regulatory, legal, medical, compliance, or marketing professional, the information will be interesting, practical, and vital.

    Highlights

    • Two breakout tracks to accommodate both novice and senior professionals
    • A prep course on March 7 for even more educational opportunities
    • Creative and interactive sessions with speakers from FDA and industry experts
    • Exhibit Hall with numerous vendors displaying new solutions and services

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Continuing-Education

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Exhibits

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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:

  • Identify the trends reflected in the latest enforcement actions and policies issued by the FDA and other legal and regulatory authorities
  • Discuss gaps in regulatory policy 
  • Examine the compliance challenges companies face, including how to evaluate challenges, and factors to consider that may impact the development of solutions
  • Discuss the best US and global review and approval practices
  • Describe emerging promotional and non-promotional tactics trending in the pharmaceutical industry that require creative and thoughtful regulatory review
  • Analyze effective digital and social media strategies designed to meet the challenges of ensuring compliance with FDA regulatory requirements

    Short Course or Primer

    To keep you at the forefront.

    Mar 07, 2018

    Ad Promo Primer :

    Learn more

    Program Committee

    • Thomas W. Abrams, MBA, RPh
      Thomas W. Abrams, MBA, RPh Retired, Director, Office of Prescription Drug Promotion, OMP, CDER
      Former FDA, United States
    • Micheline Awad, MBA
      Micheline Awad, MBA Sr. Director, Regulatory Advertising, Promotion, and Labeling
      Day One Biopharmaceuticals, 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 Head of Labeling and Advertising & Promotion, Global Regulatory Science
      Moderna, 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
    • Michele Sharp, PharmD
      Michele Sharp, PharmD Senior Director, Global Regulatory Affairs
      Eli Lilly and Company, United States
    • Wayne Pines
      Wayne Pines President, Health Care
      United States
    • Lucy Rose, MBA
      Lucy Rose, MBA President
      Lucy Rose and Associates, United States

    Digital Learning Catalog

    DIA Learning: eLearning Soultions
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