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Bethesda North Marriott Hotel and Conference Center

Oct 29, 2019 7:15 AM - Oct 30, 2019 4:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Combination Products Conference

Where regulators and industry share insights on leveraging regulatory and technological change to advance combination products.

Session 4: Cutting Edge–Artificial Intelligence and 3D Printing Revolutionizing Materials, Design, and Manufacturing

Session Chair(s)

Ryan  McGowan

Ryan McGowan

Associate Director, Combination Products

AstraZeneca, United States

Emerging technologies hold great promise for the advancement of medical care and combination product development is no exception. Recent progress in the areas of material science and digital systems will hopefully result in more effective, customized, and efficient delivery of medicines and medical devices to the market. This session will provide an example of technologies that hold particular promise as well as the practical and regulatory implications of their use in combination products.

Learning Objective : At the conclusion of this session, the participant should be able to:
  • Describe relevant emerging technologies and their potential impact to combination product development and regulation
  • Discuss recent regulatory guidance in the areas of emerging technologies and best practices for approaching regulators with novel product ideas

Speaker(s)

Bakul  Patel, MBA, MS

Artificial Intelligence and Machine Learning Technologies: Implications for Medical Products and Emerging FDA Policies

Bakul Patel, MBA, MS

Google Health, United States

Senior Director, Global Digital Health Strategy and Regulatory

Michael  Drues, PhD

Additive Printing Technologies: Applications in Combination Products and Beyond (Remote Presentation)

Michael Drues, PhD

Vascular Sciences, United States

Founder and President

Bakul  Patel, MBA, MS

Panel Discussion: Recommendations for Approaching the FDA with a Novel Technologies

Bakul Patel, MBA, MS

Google Health, United States

Senior Director, Global Digital Health Strategy and Regulatory

Michael  Drues, PhD

Michael Drues, PhD

Vascular Sciences, United States

Founder and President

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