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Session 6: Informational Session with EU
Session Chair(s)
Susan Neadle, MS
Principal Consultant and President
Combination Products Consulting Services LLC, United States
Regulatory frameworks are being introduced around the globe in efforts to ensure safe, efficacious and usable combination products for patients. Most recently, EMA has implemented updated combination products legislation under EU MDR (2017/745), and additional updates to pharmaceutical legislation are under consideration. This informational session will review Combination Products interpretation and expectations under EU MDR, and roles of EMA, National Competent Authorities and Notified bodies in the process.
Learning Objective : - Evaluate the interpretation and expectations of combination products under EU MDR
- Distinguish roles and responsibilities of EMA, Competent Authorities and Notified Bodies as part of the process
- Recognize evolving efforts under pharmaceutical legislation in EU
Speaker(s)
Speaker
Christelle Bouygues, PHARMD
European Medicines Agency, Netherlands
Senior Regulatory Affairs Officer
Speaker
Christiana Hoffman, DRSC
TÜV SÜD bei TÜV SÜD, United States
Regional Manager Focus topics
Speaker
Theresa Jeary, MSC
BSI, United Kingdom
Technical Specialist & Scheme Manager