Drug and Device Combination Products 2015: Navigating Regulation, Enhancing Collaboration, and Accelerating Development

Engage with key regulators and partners in practical approaches to navigate regulatory requirements, enhance collaboration and accelerate combination product development.

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Session 6: Global Updates

Session Chair(s)

James A. Boiani, JD, MS

Partner

Epstein Becker & Green, P.C., United States

Winifred Wu, MBA

President and Principal Advisor

Strategic Regulatory Partners, LLC, United States

Drug and Device Regulators from the EU will provide an update on the current environment for combination product approval requirements and share their insights. This session will include presentations from representatives from a Notified Body (BSI) and a Competent Authority (MHRA) followed by Q&A.

Speaker(s)

EU Regulations and Approval Process for Device/Drug Products

Elizabeth Baker

Medicines and Healthcare Products Regulatory Agency (MRHA), United Kingdom

Group Manager Licensing Division

Drug and Device Combination Products 2015

Ibim B. Tariah, PhD

Regulatory & Quality Solutions (R&Q), United States

Vice President, EU MDR & IVDR Services

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