Drug Information Association Holds Workshop on Regulatory Considerations for Product Combinations and Companion Diagnostics

Published: Nov 05, 2012

HORSHAM, PA.¬—November 5—The DIA Workshop: Regulatory Considerations for Drug/Device Combinations and Companion Diagnostics, will be held November 7-8, in Washington, D.C. at the Westin Washington, D.C. City Center, 1400 M St., NW. Participants in the interactive workshop will discuss the regulatory frameworks for drug/device combinations and drug/diagnostic pairs, and focus on the differences between development processes and regulation. Officials of the U.S. Food and Drug Administration (FDA) will also provide updates on regulatory developments and guidance.

“As technological advancements continue to merge product types under different FDA regulatory guidelines, the regulatory process can become complicated,” said DIA Program Committee chairperson Jennifer Paine, WW Vice President of Regulatory Affairs, Ortho Clinical Diagnostic, part of the Johnson & Johnson family of companies. “This essential workshop will address policy, regulatory and review management challenges, and provide a forum to discuss pre-and post-market considerations."

The workshop will begin with a keynote address by Stephen P. Spielberg, MD, PhD, Deputy Commissioner of Medical Products and Tobacco at FDA. Day one will focus on combination products, day two will centered on companion diagnostics, and the conference will conclude with an in-depth panel discussion about the future of both.

Workshop sessions will include:

• Industry Perspective: Working with FDA on Combination Products, presented by Winifred C. Wu, President and Principal, Strategic Regulatory Partners, LLC

• Adverse Event Reporting, presented by Leighton Hansel, Director of Regulatory Affairs, Medical Products Group, Abbott Laboratories

• Post-market Changes, presented by Danelle R. Miller, Regulatory Counsel, Roche Diagnostics

• Premarket Biomarker Development and Validation: Drug Developer Perspective, presented by Shirin Khambata Ford, PhD, Executive Director, Global Head, Oncology Correlative Sciences, Novartis Pharmaceuticals Corporation

• FDA Perspective, presented by John (Barr) Weiner, JD, Associate Director, Office of Combination Products, FDA

Register now for Regulatory Considerations for Drug/Device Combinations and Companion Diagnostics.


DIA is a neutral, global, professional and member-driven association of nearly 18,000 professionals involved in the discovery, development and lifecycle management of pharmaceuticals, biotechnology, medical devices and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well-being worldwide. Headquarters are in Horsham, Pa., USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; Beijing, China; Washington, D.C.; and Latin America. Visit our website at www.diahome.org; follow DIA on Facebook, Twitter (#druginfoassn), LinkedIn, Flickr and YouTube.

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