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Event Series: Combination Products Summit Workshop 2023

Combination Products Risk Management: Integration of ICH Q9(R1) and ISO 14971:2019

November 28 @ 10:50 am – 2:20 pm

This topic will be split into two parts, with a break in the middle for lunch. View more about the topic below:

ICH Q9(R1) has recently been adopted (January 2023), and ISO 14971:2019 has been recognized as a global harmonized standard. Combination Products Risk Management leverages and integrates each of these. Review and discuss the latest on each of the harmonized standards and discuss expectations for/ challenges with integration for combination products.

Activity Documents

Leading Facilitators

Tine Albeck, Senior Quality Assurance Professional, ALK A/S

Facilitators

Milind Ganjawala, Division Director of Drug Quality II, Center for Drug Evaluation and Research (CDER), FDA
Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC
Rick Wedge, Compliance Lead / Associate Research Fellow, Pfizer

Omni Fort Worth Hotel

1300 Houston Street
Fort Worth, Texas 76102 United States

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About the Association of Food and Drug Officials (AFDO)

The Association of Food and Drug Officials (AFDO) is a well-recognized national organization that represents state, territorial, and local regulatory. The Association’s principal purpose is to act as the leader and a resource to state, territorial, and local regulatory agencies in developing strategies to resolve and promote public health and consumer protection related to the regulation of food, medical products, and cosmetics. Visit AFDO at www.afdo.org.

About Regulatory Affairs Professionals Society (RAPS)

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of professionals involved with regulatory and quality for healthcare products, including medical devices, pharmaceuticals and biologics, diagnostics, and digital health. Founded in 1976 as a neutral, nonprofit organization, RAPS supports and elevates the regulatory profession with education and training, professional standards, publications, research, networking, career development, and other valuable resources. RAPS is home to the Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. The society is headquartered in suburban Washington, D.C., with chapters and affiliates worldwide. www.raps.org.

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