Dr. Silke Conrad, Novartis - Qepler Summits And Conferences

Dr. Silke Conrad

Quality Expert Medical Device
Basel, Switzerland

Silke Conrad is currently Quality Expert for Medical Device Development at Novartis Pharma AG. In her current role, she mainly supports medical devices and combination products from a QA perspective, negotiates and approves QA agreements and establishes and maintains QA processes for medical device development. Silke joined Novartis in 2011 as Regulatory CMC Associate Director for Biologics from the medical devices company Ypsomed AG/Switzerland, where she was leading the regulatory affairs department.

Prior to Ypsomed AG, Silke worked for Sanofi-Aventis in Frankfurt/Germany and Holmes Chapel/UK holding different positions in Regulatory Affairs and Quality Assurance with main focus on biotech/biological products and combination products.

Silke is a food chemist/environmental toxicologist from education and holds a doctorate degree in molecular biology/cancer research from the Technical University of Kaiserslautern/Germany.

Related Sessions:

Drug/Device Combination
Products Summit 2018

Get up to date with the regulatory and quality compliance strategies for combination product development.
  • 04 Dec 2018
  • Berlin, DE
  • Pharma
Day 1: Tuesday, 04 December 2018
CASE STUDY: Combination Products - regional similarities and differences in GMP.
  • Combination Product (resp. Drug Product) definitions (US/EU/CA/JP/Brazil/Australia/India).
  • GMP requirements in the countries listed above; with focus on single integral products, intended exclusively for use in the given combination, not reusable (PMOA DP).
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Medical Device
Regulations Summit 2021

Exploring EU MDR and IVDR updates and preparing company for new requirements implementation.
  • 08 Jul 2021
  • Virtual,
  • Pharma
Day 1: Thursday, 08 July 2021
CASE STUDY: Updating the QMS to MDR.
  • MDR – Main changes.
  • QMS gap analysis on existing combination product/medical device processes and action plan.
  • Step wise implementation.
View Details