Combination Products Summit 2023

Workshop

November 28th, 2023 — Combination Products Summit Workshop Agenda

November 28, 2023 @ 7:00 am

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8:00 am

Breakfast

Join your colleagues from around the globe as we kick off the Combination Products Summit with a complimentary hot breakfast!

November 28, 2023 @ 8:00 am

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10:30 am

Notified Body Opinion Workshop – Experiences And Lessons For Combination Products In EU

It has been three years since Notified Body Opinions have been required for integral combination products in the European Union (EU) under the requirements of Article 117 of the EU Medical Device Regulations. In the intervening time, both industry and notified bodies have learned more about expectations of these submissions, however key elements also remain uncertain which places some combination products at approval risk due to lack of clarity on expectations. This session will provide an overview of Notified Body Opinions in EU, cover practical considerations and best practices in delivering the submissions, and explore some key areas of uncertainty such as post-approval substantial changes.

Facilitators

(Leading Facilitator) Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca

(Leading Facilitator) James Wabby, Global Head – Emerging Technologies, Combination Products, and Devices, Abbvie

Arabe Ahmed, Bsi Group

Timothy Chesworth, Senior Director Regulatory Affairs – Devices & Digital Therapeutic, AstraZeneca

Katie Chowdhury, Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVie

Amanda Matthews, Senior Director, Regulatory CMC for Combination Products & Medical Devices, Pfizer

November 28, 2023 @ 10:00 am

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2:00 pm

FDA Office Hours

The meeting is open to you and colleagues from your company. To attend FDA Office Hours, you and anyone joining you must be a registered attendee of the 2023 Combination Products Summit. Appointments are limited, and you must sign up online to secure your spot.

Moderators

James Bertram, Director, Office of Combination Products (OCP), U.S. Food and Drug Administration (FDA)

John “Barr” Weiner, Associate Director for Policy, Office of Combination Products (OCP), U.S. Food and Drug Administration (FDA)

November 28, 2023 @ 10:30 am

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10:50 am

Break

November 28, 2023 @ 10:50 am

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2:20 pm

Combination Products Risk Management: Integration Of ICH Q9(R1) And ISO 14971:2019

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.

Download Activity Documents

Facilitator

(Lead Facilitator)Tine Albeck, Senior Quality Assurance Professional, ALK A/S

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

November 28, 2023 @ 11:50 am

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12:50 pm

Lunch

November 28, 2023 @ 2:40 pm

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5:10 pm

Risk Management Application In Post-Market Safety & Other PMSR Hot Topics

An interactive workshop session on post-market safety and end-to-end application of risk management principles in the post market setting. There will be discussion around PMSR (post-implementation) and the successes and challenges related to our journey as cross-functional stakeholders coming together for a bigger purpose. Through examples and practical approaches, we will explore the related people, process and technology. We will deep dive into the Information exchange about adverse events and complaints coding challenges. We look to answer:

“Does the quality of data submitted in the reports meet its intent and purpose?”.
What are the unique challenges with third party engagements, and what are the solutions to mitigate?
Learn about organizational models that best fit your needs to support global PMSR requirements.
What transformations in technology are needed to support your needs.

Facilitator

(Leading Facilitator) Khaudeja Bano, Vice President, Combination Product Quality, Amgen

(Leading Facilitator) Rich Wolf, Head of Pv Operations at CSL Behring

John “Barr” Weiner, Associate Director for Policy in FDA’s Office of Combination Products (OCP), FDA

Fubin Wu, Co-founder, GessNet Safety Engineering

Kate Gillespie, Sr. Director, Global Product Vigilance and Post Market Reporting, Johnson & Johnson

November 28, 2023 @ 5:10 pm

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5:30 pm

Q&A Session

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.