Drug Information Association Holds Workshop on Regulatory Considerations for Product Combinations and Companion Diagnostics
Published: Nov 05, 2012
“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.
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