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February 22: Ad Promo Primer*
February 23-24: Conference

*Primer requires separate registration.

DIA’s Advertising and Promotions Regulatory Affairs Conference, formerly known as the DIA Marketing Pharmaceutical Conference, has a comprehensive agenda covering the latest updates in the ad promo regulatory space. You will participate in discussions on the new and emerging industry trends as well as examine and analyze new FDA guidances and initiatives. This conference will provide you with the opportunity to network with regulatory and legal professionals, as well as industry leaders in advertising and promotion. Whether you’re just starting out or have years of expertise and knowledge, this conference can be customized to meet your needs!

Approved by the Regulatory Affairs Professionals Society for 12 RAC credits.

Schedule At-A-Glance

Session 1: FDA: Focus on New Initiatives Enforcement

Session 2: FDA Draft Guidance and Initiatives

Session 3: OPDP Research Agenda

Session 4A: Considerations for Expanding Proactive Communications by Biopharmaceutical Manufacturers to Population Health Decision Makers -or- Session 4B: Deep Dive: Live and Field-Based Tactics

Session 5: Navigating the Murky Waters of Off-Label Communications: Promotion, Commercial Speech, and Scientific Exchange

Session 6: Question and Answer Session with FDA

Session 7: Mobile Apps – When Are They Promotions, When Are They Regulated Devices?

Session 8A: Ad-Promo's Role in the Adoption of Technology across the Organization -or- Session 8B: Deep Dive: Digitial Tactics

Session 9A: Considerations for Developing a Productive Advertising and Promotion Team -or- Session 9B: Building Bridges: Creating and Maintaining a Productive Relationship with FDA on Advertising and Promotion Issues

Session 10: Patient Support Programs

Featured topics

  • New and Emerging Technologies
  • FDA Update: Recent Actions and Guidances
  • Mobile Applications
  • Strategic (Practical) Considerations for FDA Interactions
  • Review of DOJ Cases
  • Off Label Promotion/Off Label Communications
  • Broad FDA Initiatives
  • OPDP Research Agenda

Who should attend?

Professionals involved in:

  • Regulatory Affairs
  • Marketing
  • Communications
  • Compliance
  • Medical Information and Affairs
  • Legal
  • Senior Management
  • Pharmaceuticals
  • Biologics
  • Medical Devices

Learning objectives

At the conclusion 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

Program Committee

  • Thomas W. Abrams, MBA, RPh
    Thomas W. Abrams, MBA, RPh Director, Office of Prescription Drug Promotion, OMP, CDER
    FDA, United States
  • Glenn  Byrd, MBA, RAC
    Glenn Byrd, MBA, RAC
    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 NA General Medicines/US Advertising and Promotion
    Sanofi, United States
  • Tracy  Rockney, JD
    Tracy Rockney, JD Co-Founder and Managing Partner
    OneSource Regulatory, United States
  • Paul  Savidge, JD, MBA
    Paul Savidge, JD, MBA Senior Regulatory Counsel
    Spark Therapeutics, Inc., 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
    APCO Worldwide Inc., United States
  • Lucy  Rose, MBA
    Lucy Rose, MBA President
    Lucy Rose and Associates, LLC, United States
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