FDAnews Announces — CBER’s Five-Year Plan: Address the Agency’s New Priorities and Stay Compliant in a Post-COVID-19 World Webinar July 13, 2021

WCG FDAnews

WCG FDAnews

CBER’s Five-Year Plan:
Address the Agency’s New Priorities and Stay Compliant in a Post-COVID-19 World
An FDAnews Webinar
Tuesday, July 13, 2021, 1:30 p.m.-3:00 p.m. EDT
https://wcg.swoogo.com/cbers-five-year-plan

Ready to address CBER’s new priorities? What it takes to stay compliant is changing… and this is how to stay ahead.

One must incorporate advanced manufacturing processes and use machine learning (ML) and artificial intelligence (AI) along with real-world data (RWD) and real-world evidence (RWE). So says the CBER 2021-2025 Strategic Plan. Its goals require incorporating innovative technologies to more quickly develop safe and effective biologics.

Kalah Auchincloss, JD, MPH, and Madeleine Giaquinto, JD, of Greenleaf Health, Inc. will share how to implement strategic engagement and planning and develop a quality and compliance strategy that aligns with CBER’s regulatory expectations.

They will explain:

  • The relevance of CBER’s four overarching goals for FY 2021-2025, which makes up the structural framework of its Strategic Plan, the objectives of each goal and the proposed strategic activities required to achieve each objective
  • What one must understand about CBER’s four priorities that will inform its policy decisions for the next five years, including addressing the COVID-19 outbreak; developing a regulatory program for individual or bespoke therapies; facilitating compliance with human cells, tissues and cellular and tissue-based product regulations; and advancing manufacturing technologies for biologic products
  • An analysis of the role CGT and personalized medicine development, advanced manufacturing technologies and AI/ML, RWE and RWD will play in CBER’s strategic and regulatory activities
  • An overview of new legislation enacted since the last plan was published and designed to accelerate medical production development, including the Cures Act, the FDA Reauthorization Act of 2017 (FDARA) and the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA)
  • Additional factors that may impact CBER’s Strategic Plan, including the American Rescue Plan Act of 2021, Biden administration executive orders calling for review of pharmaceutical supply chains, FDA’s COVID-19 PREPP Initiative Report and FDA/NIST MUO on “Accelerating the Adoption of Advanced Manufacturing Technologies to Strengthen Our Public Health Infrastructure”

This is a must-attend webinar if one is developing or producing CBER-regulated products.

Webinar Details:
CBER’s Five-Year Plan:
Address the Agency’s New Priorities and Stay Compliant in a Post-COVID-19 World
An FDAnews Webinar
Tuesday, July 13, 2021, 1:30 p.m.-3:00 p.m. EDT
https://wcg.swoogo.com/cbers-five-year-plan

Tuition:
$287 per site

Easy Ways to Register:
Online: https://wcg.swoogo.com/cbers-five-year-plan
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

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