Speakers

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Senior Representative
Phillips-Medisize, LLC

Jonathan Amaya-Hodges
Associate Director, Regulatory Affairs
Biogen

John McMichael
Associate Director, Combination Products
AstraZeneca

Day Two

Thursday 27 June

10:10 am | Panel Discussion: What Does a Good Control Strategy Look Like and Its Importance to Drive a Sustainable Lifecycle?

Kristina Lauritsen
Combination Products Regulatory Advisor
FDA

Day One

Wednesday 26 June

9:40 am | Panel Discussion: How to Handle Regulatory Uncertainty and What Does It Mean to Your Combination Products’ LCM?

Day Two

Thursday 27 June

9:10 am | Keynote Address: Building the Engagement and Dialogue with the FDA

Stephen Fournier
Director – Device Platform Management
Alnylam Pharmaceuticals

Day One

Wednesday 26 June

4:30 pm | Be Smart – Strategic Platforming for Your Combination Products

Eiichi “H.E.” Sengoku
Director, GRL for Medical Devices & Combination Products
UCB, Inc.

Day Two

Thursday 27 June

11:40 am | Is Connectivity the Answer?

Suzette Roan
Director, Global Regulatory Affairs
Sanofi

Day One

Wednesday 26 June

9:40 am | Panel Discussion: How to Handle Regulatory Uncertainty and What Does It Mean to Your Combination Products’ LCM?

9:10 am | Keynote Address: Who Is in Charge? Securing Early Support from the FDA

Michael Roe
Director – Device Development & Industrialization
kaleo

Day One

Wednesday 26 June

4:00 pm | Kaleo’s Successful Injectable Story – From Concept to Product Commercialization

John Schalago
Head, Global Regulatory Affairs, Devices & Applications
EMD Serono

Day Two

Thursday 27 June

11:10 am | Catching Up on the Digitalization Trend?

Prasad Peri
Senior Director, Regulatory Affairs, CMC
Teva

Helen Kim
Associate Director, RA, Device & Combination Products
Allergan

Day One

Wednesday 26 June

9:40 am | Panel Discussion: How to Handle Regulatory Uncertainty and What Does It Mean to Your Combination Products’ LCM?

Raihan Hossain
Associate Director of CH I&D Medical Device Quality
Bayer

Day Two

Thursday 27 June

10:10 am | Panel Discussion: What Does a Good Control Strategy Look Like and Its Importance to Drive a Sustainable Lifecycle?

9:40 am | Case Study: How Can Quality Contribute to a Winning Product and LCM?

Will Sutton
VP Engineering & Technology
Minnetronix Medical

Day One

Wednesday 26 June

11:30 am | Innovation Talk: Leveraging Medical Device Expertise to Develop Combination Therapies

Alastair Clarke
Managing Principal
Weaver Technical Solutions

Leonel Vanegas
Quality Assurance Director, Medical Devices & Combination Products
Merck & Co.

Day One

Wednesday 26 June

11:45 am | Embedding Lifecycle Management Early On – but How Early?

Margaret Kelly
Device Manager, Device Development & Commercialization
Novartis

Day One

Wednesday 26 June

1:15 pm | Excellent Integration of Design Control throughout LCM

Naveen Agarwal
Principal & Founder
Creative Analytics Solutions

Winifred Wu
President & Principal Advisor
Strategic Regulatory Partners, LLC