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Bethesda North Marriott Hotel and Conference Center

2027 年 02 月 22 日 7:00 上午 - 2027 年 02 月 23 日 5:00 下午

5701 Marinelli Road, North Bethesda, MD 20852

Advertising and Promotion Regulatory Affairs Conference

Advancing Advertising and Promotion in the Age of Innovation

概览

Conference: February 22-23 | 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.

Amid increased regulatory attention and new cross-agency initiatives focused on advertising and promotion, attendees will gain timely insights into how evolving 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.

While we develop our 2027 agenda, please take a moment to review the 2026 Final Agenda.

谁应该参加?

  • Conference Designed for:

    Professionals involved in the following areas:

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

学习目标

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
  • Describe ways to enhance PRC performance and cross-functional alignment to drive efficient, compliant, and innovative promotional strategies

项目委员会

  • Janet  Gottlieb, PhD
    Janet Gottlieb, PhD Head of Medical Review Solutions
    Canopy Life Sciences, United States
  • Kristen  Heinlein, PharmD
    Kristen Heinlein, PharmD Vice President, Advertising & Promotion Regulatory
    Takeda, United States
  • Mary  Johnson, PhD, RAC
    Mary Johnson, PhD, RAC Consultant
    StratPhD LLC, United States
  • Darshan  Kulkarni, JD, PharmD, MS, RPh
    Darshan Kulkarni, JD, PharmD, MS, RPh Principal Attorney
    Kulkarni Law Firm, PC, United States
  • John Paul  Marcus, PharmD
    John Paul Marcus, PharmD Executive Director, Regulatory Compliance
    Ionis Pharmaceuticals, United States
  • Twyla  Mosey, PharmD
    Twyla Mosey, PharmD Acting Office Director, OPDP, CDER
    FDA, United States
  • Joshua  Oyster, JD
    Joshua Oyster, JD Partner
    Ropes & Gray, United States
  • Gina  Vestea, PharmD
    Gina Vestea, PharmD Head, Global Regulatory Affairs Advertising & Promotion
    Sanofi, United States
  • Heta  Zaveri, PharmD, MBA
    Heta Zaveri, PharmD, MBA Regulatory AdPromo Practice Leader
    Opus Regulatory, United States
  • Representative Invited
    Representative Invited DIA, Switzerland
  • Micheline  Awad, MBA
    Micheline Awad, MBA Sr. Director, Regulatory Advertising, Promotion, and Labeling
    Day One Biopharmaceuticals, United States

Digital Learning Catalog

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