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Hyatt Regency Bethesda

2025 年 02 月 24 日 7:00 上午 - 2025 年 02 月 25 日 4:20 下午

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

Session 6: Unlocking the Potential of your Promotional Review Committee OR Navigating the Complexities of PRC Management

Session Chair(s)

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, Regulatory Advertising and Promotion

Sage Therapeutics, United States

This session will delve into the strategic management of promotional review committees (PRC). We will explore the best practices for ensuring launch readiness, managing post-approval activities, reviewing and approving CFL data, and making informed risk decisions. Additionally, we will discuss effective training strategies, from training project owners on regulatory fundamentals to preparing new regulatory reviewers. At the end of this session, attendees will gain valuable insights to optimize their PRC and drive maximum promotional success.

Learning Objective :
  • Identify strategies to streamline the PRC review and approval process for product launches, post-approval activities, CFL data and determining the appropriateness of supporting studies
  • Develop effective training programs to equip project owners and regulatory reviewers with the necessary knowledge and skills to ensure compliance and mitigate risks
  • Explore frameworks and tools for conducting risk assessment and making informed decisions about the use of CFL data

Speaker(s)

Jan  Owen, MPH

Speaker

Jan Owen, MPH

Sage Therapeutics, United States

Director, MLR Operations Excellence

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