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Hyatt Regency Bethesda

24 feb 2025 7:00 a.m. - 25 feb 2025 4:20 p.m.

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Advertising and Promotion Regulatory Affairs Conference

Advancing Advertising and Promotion in the Age of Innovation

Early Bird Registration Expires

DAYS

HOURS

MINUTES

SECONDS

Perspectiva general

Conference: February 24-25, 2025 | In-Person

This conference delves into the evolving regulatory landscape for advertising and promotion of biopharmaceuticals and medical devices, with a focus on innovation, compliance, and patient-centric communication. Attendees will explore cutting-edge topics such as the application of artificial intelligence in promotional review, the distinction between scientific communication and promotion, and strategies for engaging diverse patient populations.

Join thought leaders from industry, legal, public affairs, and government for interactive discussions that will shape policy, define strategic priorities, and provide actionable insights into regulatory expectations and best practices.

Designed for professionals at all career stages, this conference offers a comprehensive understanding of current FDA policies, emerging trends in digital marketing and disease awareness campaigns, and practical tools for optimizing promotional review processes. Network with experts from the FDA, industry, and regulatory agencies to tackle the challenges and opportunities in today's fast-evolving advertising and promotion space.


Need Approval in Order to Attend?

Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.


Participant Testimonials

It was a great event. The speakers and panels were very informative, relevant, and organizedwell. It was also a wonderful opportunity to network and meet new individuals who work in thesame/similar role at other companies. – James Chang, Associate Manager Regulatory Advertising and Promotion, Astellas

This conference is a great opportunity to learn recent trends in our industry, and hear about exciting issues hot topics. It was so great to see everyone in person again as well and network. – Kavita Vazirani, Principal Consultant, Opus Regulatory, Inc.

All levels of regulatory A&P expertise can benefit from it. Besides educational presentations, the face-to-face social networking aspect of this event was exceptionally good. Breaks after every session helped us refreshed and focused. – Iram Quraishi, Director Regulatory A&P, Takeda

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¿Quiénes deben asistir?

  • Conference Designed for:

    Professionals involved in the following areas:

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

Objetivos de aprendizaje

At the conclusion of this activity, participants should be able to:
  • Summarize the latest FDA policies, guidance documents, and regulations impacting advertising and promotion globally to ensure compliance
  • Identify strategies to address common pitfalls and ensure compliant advertising and promotion activities across traditional and digital platforms
  • Explore how artificial intelligence and machine learning can optimize the advertising and promotional review process while maintaining compliance
  • Differentiate between medical communication and promotion to effectively engage patients and advocacy groups within regulatory guidelines
  • Examine best practices for optimizing promotional review committees (PRCs) to support launch readiness and post-approval activities
  • Analyze emerging trends in digital transformation and regulatory expectations to prepare for the evolving landscape of healthcare promotion
  • Design and summarize compliant disease awareness campaigns that effectively engage target populations without promoting treatments
  • Plan and apply strategies to incorporate AdPromo regulatory insights early in brand planning to enhance campaign effectiveness

Comité del programa

  • 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
  • Lynn  Bowen, PhD
    Lynn Bowen, PhD Vice President, Regulatory Affairs Advertising Promotion & Labeling
    Alkermes, Inc., United States
  • Anthony  Genovese, PharmD
    Anthony Genovese, PharmD Group Leader, Regulatory Advertising and Promotion
    Johnson and Johnson, United States
  • Nicol Lorraine George, PharmD, RPh
    Nicol Lorraine George, PharmD, RPh Vice President, Promotional Review & Labeling Services
    ProPharma Group, United States
  • Moulakshi  Roychowdhury, JD, PharmD
    Moulakshi Roychowdhury, JD, PharmD Global Head, Regulatory Affairs, Advertising & Promotion, Allergan Aesthetics
    AbbVie, United States
  • Virginia  Foley
    Virginia Foley VP Regulatory, Life Sciences & Healthcare
    Constellation, United States
  • Stephen  Shinall, PhD
    Stephen Shinall, PhD Director of Regulatory Affairs
    Biogen, United States
  • Zoe  Dunn
    Zoe Dunn President & CEO
    Hale Advisors, Inc., United States
  • Heta  Zaveri
    Heta Zaveri Practice Leader- Advertising and Promotion
    Opus Regulatory, United States
  • Twyla  Mosey, PharmD
    Twyla Mosey, PharmD Division Director
    FDA, United States
  • Representative Invited
    Representative Invited DIA, United States
  • Mark  Gaydos
    Mark Gaydos Former Global Head, Advertising & Promotion, Global Regulatory Affairs
    Sanofi, United States
  • Micheline  Awad, MBA
    Micheline Awad, MBA Sr. Director, Regulatory Advertising, Promotion, and Labeling
    Day One Biopharmaceuticals, United States

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