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Bethesda North Marriott Hotel and Conference Center

Feb 23, 2026 7:00 AM - Feb 24, 2026 3:00 PM

5701 Marinelli Road, North Bethesda, MD 20852

Advertising and Promotion Regulatory Affairs Conference

Advancing Advertising and Promotion in the Age of Innovation

Early Bird Rates Expire

DAYS

HOURS

MINUTES

SECONDS

Overview

Conference: February 23-24, 2026 | In-Person

This conference explores 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.

Amid increased regulatory attention and new cross-agency initiatives focused on advertising and promotion, attendees will gain timely insights into how eveolving policies are shaping compliance expectations across traditional, digital, and AI-driven channels. Session will address cutting-edge topics such as the application of artificial intelligence in promotional review, the practical application of the new Scientific Information on Unapproved Uses (SIUU) guidance, the integration of patient-reported outcomes (PROs) in labeling and communications consistent with labeling (CFL), and emerging trends in digital and social media promotion.

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

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 environment.

Participant Testimonials

It provided recent and relevant education in regs, enforcement and trends, different viewpoints from regulatory experts of varying backgrounds and was also a great networking opportunity. – Kelly Fitzgerald, Senior Manager, US Regulatory Advertising & Promotion, Takeda Pharmaceuticals

Interesting and relevant topics. Engaging speakers. – Tiffany Iwamura, Advertising and Promotion, Manager, Chiesi Pharmaceuticals

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Exhibits

Highlights & Features

Who should attend?

  • Conference Designed for:

    Professionals involved in the following areas:

    • 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:
  • Identify cross-agency regulatory and enforcement trends that shape promotional practices
  • Discuss updated FDA/OPDP expectations and recent policy developments into promotional review and decision-making
  • Assess the opportunities and risks of AI, digital platforms, and new communication channels in advertising and promotion
  • Apply compliant approaches to PROs, SIUU, HCEI/RWE/PIE, and other complex communication areas
  • Enhance PRC performance and cross-functional alignment to drive efficient, compliant, and innovative promotional strategies

Program Committee

  • Alyson  Andrikanich, PharmD
    Alyson Andrikanich, PharmD Senior Director, Advertising and Promotion, Regulatory Affairs Americas
    Bayer Pharmaceuticals, United States
  • Lynn  Bowen, PhD
    Lynn Bowen, PhD Vice President, Regulatory Affairs Advertising Promotion & Labeling
    Alkermes, Inc., United States
  • Zoe  Dunn
    Zoe Dunn President & CEO
    Hale Advisors, Inc., United States
  • Virginia  Foley
    Virginia Foley Founder, CEO
    Compliance Forward, United States
  • Anthony  Genovese, PharmD
    Anthony Genovese, PharmD Group Leader, Regulatory Advertising and Promotion
    Johnson & Johnson, United States
  • Nicol  George, PharmD, RPh
    Nicol George, PharmD, RPh Executive Vice President, Promotional Review & Labeling Services
    ProPharma Group, United States
  • Darshan  Kulkarni, JD, PharmD, MS
    Darshan Kulkarni, JD, PharmD, MS Principal Attorney
    Kulkarni Law Firm, PC, United States
  • Twyla  Mosey, PharmD, RPh
    Twyla Mosey, PharmD, RPh Division Director
    FDA, United States
  • Heta  Zaveri, PharmD, MBA
    Heta Zaveri, PharmD, MBA Ad Promo Account Executive
    Opus Regulatory Inc, United States
  • Micheline  Awad, MBA
    Micheline Awad, MBA Sr. Director, Regulatory Advertising, Promotion, and Labeling
    Day One Biopharmaceuticals, United States
  • Georgina  Lee, PharmD
    Georgina Lee, PharmD Executive Director, Global Regulatory Labeling, Advertising and Promotion
    Disc Medicine, United States

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