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Session 4: What the Medical Device Regulation Means For Pharmacovigilance
Session Chair(s)
James Whitehead, MBA, MSc
Senior Director, Device & Digital Safety
AstraZeneca, United Kingdom
This session will be dedicated to reviewing and reflecting on the impact of the EU Medical Device Regulation which becomes effective on 26th May 2020. The session will explore the Person Responsible for Regulatory Compliance (Article 15), the impact on device constituents (Article 117) and how various stakeholders are implementing the regulation.
Speaker(s)
EU PRRC Role
James Whitehead, MBA, MSc
AstraZeneca, United Kingdom
Senior Director, Device & Digital Safety
Notified Body’s Role in Medicinal Products Which Utilise a Medical Device (Combination Product)
Julia Frese, MBA
TÜV SÜD , Germany
Department Manager Centre of Combination Products
Combination Products: Definition and Differences Between US and EU
Khaudeja Bano, DrMed, MD, MS
Amgen, United States
Vice President, Combination Product Quality
Panel discussion with Q&A, with the additional participation of:
Syed Muntasir
TÜV SÜD Ltd, United Kingdom
Medical Health Services Executive
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