Topic: RWD/RWE – The Latest FDA, EMA, and MHRA Guidance Issued
Use of real-world evidence can accelerate drug development and product approvals. However, the acceptable use of real-world evidence for regulatory purposes is rapidly evolving area where industry and agencies are still working to define the criteria. Within the last 6 months, FDA, EMA, and MHRA issued a total of six guidances providing sponsors recommendations to help ensure that RWD collected is fit for purpose and can be used as RWE. The presenters will provide an overview of the six guidances as well as current examples to showcase the successful use of RWE in addition to common pitfalls encountered.
The Presenters
Kimberly (Kim) Belsky , Executive Director Regulatory Policy & Intelligence and AdPromo, Mallinckrodt Pharmaceuticals. Kim has more 30 years in the pharmaceutical industry including 20+ years in regulatory affairs covering a diversity of medical products including Rx drug/biologics, OTCs/Nutritionals/Cosmetics, and medical devices. Kim holds a master’s degree in chemistry from SUNY Stony Brook and has several scientific publications including a recent review entitled, “The Regulatory Environment for Tissue-Engineered Products for the Treatment of Burns in the United States”.
Chris Whalley, Associate Director Regulatory Affairs, Seagen Inc. Chris brings more than 20 years industry experience in medicinal product development and commercialization in organizations ranging from venture-funded startups and non-profit medical centers to global public enterprises. In addition to his operational and regulatory expertise in oncology biopharmaceuticals and combination products, Chris has also led the development of cloud computing and machine learning programs supporting FDA-regulated laboratories, clinical trials, and manufacturing plants, and he holds a patent on technology for supplying regulatory compliance evidence in cloud computing environments.
Regulatory Affairs Community Regulatory Intelligence WG is inviting you to a scheduled Zoom meeting.
When: Feb 15, 2022 12:00 PM Eastern Time (US and Canada)
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