CBER’s Five-Year Plan: Address the Agency’s New Priorities and Stay Compliant in a Post-COVID-19 World – Webinar Recording/Transcript
Addressing CBER’s new direction for regulatory, quality and compliance oversight is a must to stay compliant.
CBER’s 2021-2025 Strategic Plan is a clear response to current threats posed by COVID-19 and the agency’s focus on incorporating lessons learned for future pandemics to streamline supply chains and mitigate product shortage risks. Its goals require incorporating innovative technologies to more quickly develop safe and effective biologics.
Know this: CBER’s emphasis is on incorporating advanced manufacturing processes and using machine learning (ML) and artificial intelligence (AI) along with real-world data (RWD) and real-world evidence (RWE). Will you be left behind?
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.
Ms. Auchincloss is executive vice president and deputy general counsel and a former FDA staffer in CDER’s Office of Compliance as well as former deputy chief of staff to the FDA commissioner, while Ms. Giaquinto is manager of regulatory affairs.
- 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 you 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”
If you’re developing or producing CBER-regulated products, this is a must-attend webinar.
Meet Your Presenters
Kalah Auchincloss, JD, MPH is executive vice president and deputy general counsel at Greenleaf Health, Inc., providing strategic counsel to clients on compliance, enforcement and policy matters. She spent six years at FDA prior to joining Greenleaf in 2017, including time in CDER’s Office of Compliance and as deputy chief of staff to the FDA commissioner. Ms. Auchincloss was also a primary point of contact in the immediate Office of the Commissioner for the six FDA centers and other components of the Commissioner’s Office.
Madeleine Giaquinto, JD is a manager of regulatory affairs at Greenleaf Health, Inc., where she provides clients with timely analysis of FDA regulations, policies and guidance documents as well as strategic advice on FDA engagement regarding compliance-focused issues and good practice standards for FDA-regulated products. Ms. Giaquinto advises clients on strategic engagement with the FDA regarding a range of compliance issues. She has published articles on topics ranging from the root causes of drug shortages along global supply chains, the DOJ’s evaluation of corporate compliance programs in the context of FDA-regulated products and FDA’s regulatory activities in response to COVID-19 and in future pandemic preparedness efforts.
Who Will Benefit
- Regulatory affairs personnel
- Government affairs personnel
- Quality affairs personnel
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July 13, 2021