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Session 6: Navigating the Complexities of PRC Management
Session Chair(s)
Micheline Awad, MBA
Sr. Director, Regulatory Advertising, Promotion, and Labeling
Day One Biopharmaceuticals, United States
Georgina Lee, PharmD
Executive Director, Global Regulatory Labeling, Advertising and Promotion
Disc Medicine, 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)
Navigating the Complexities of PRC Management | Module 1: PRC Efficiency
Jan Owen, MPH
Sage Therapeutics, United States
Director, MLR Operations Excellence
Module 2: Strengthening Regulatory Expertise
Micheline Awad, MBA
Day One Biopharmaceuticals, United States
Sr. Director, Regulatory Advertising, Promotion, and Labeling
Module 3: Optimizing Risk Decision-Making
Georgina Lee, PharmD
Disc Medicine, United States
Executive Director, Global Regulatory Labeling, Advertising and Promotion