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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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The use of real-world evidence can accelerate drug development and product approvals. However, the acceptable use of real-world evidence for regulatory purposes is a rapidly evolving area where industry and agencies are still defining the criteria.
In late 2021, 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, relevant publications, as well as current examples to showcase the successful use of RWE in addition to common pitfalls encountered. A live Q&A portion with the speaker will follow the presentation.
This event is brought to you by the RAPS NJ NY Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.
Members: $0, Nonmembers $25
After this program, participants will be able to:
Industry personnel involved in the following roles: Regulatory Strategy Regulatory Policy and Intelligence Health Economics Reimbursement
Instructors:
Kimberly (Kim) Belsky Executive Director Regulatory Policy & Intelligence and AdPromo Mallinckrodt Pharmaceuticals
Kimberly (Kim) Belsky is executive director of regulatory policy and intelligence, and labeling operations at Mallinckrodt Pharmaceuticals. In this role, she is responsible for assessing changes in the global regulatory environment relevant to the company portfolio to identify opportunities and challenges in rare diseases and unmet medical needs. Additionally, she has responsibility for managing the labeling for the company’s global drug/biologic products. Belsky has more than 30 years in the pharmaceutical industry, including 20 years in regulatory affairs covering a diverse range of products, including prescription drugs and biologics, over-the-counter medicines, nutritional products, cosmetics and medical devices. She has served on several RAPS committees and currently chairs the Convergence 2022 Planning Committee. Belsky received RAPS’ Community Leadership Award in 2017. She earned a master’s in chemistry from the State University of New York at Stony Brook.
Chris Whalley Associate Director Regulatory Affairs Seagen Inc.
Chris Whalley is the associate director of regulatory affairs at Seagen Inc. He has more than 20 years of industry experience in medicinal product development and commercialization with organizations ranging from venture-funded startups and nonprofit medical centers to global public enterprises. Whalley has extensive operational and regulatory expertise in oncology biopharmaceuticals and combination products. He also has led the development of cloud computing and machine learning programs supporting FDA-regulated laboratories, clinical trials and manufacturing plants and holds a patent on technology for supplying regulatory compliance evidence in cloud computing environments.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
All cancellation requests must be submitted in writing to raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
RAPS will send an electronic letter or a certificate of attendance at the following the workshop.
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