MHRA speaker:
Providing advice on adapting to changing regulatory requirements
3 Notified Body representatives:
NSAI, BSI and DEKRA certification
Real life case studies on running clinical trials:
Successes, what went wrong, and what has been learned
Practically meeting requirements for MEDDEV 2.7.1 – Rev. 3, Serious Adverse Events reporting, pre-market and post-market clinical studies:
Real life examples and advice
Drug Device Combination Products:
How to practically implement a clinical
evaluation and a clinical investigation case study
Real life examples on challenges with equivalence claims, practically implementing PMCF and medical device registries:
Advice from large and small medical devices manufacturers
Pre-Conference Workshop W: Tuesday 24 April 2012
Practical guide to conducting a successful Clinical Evaluation: Real life data
Evening Seminar Y: Wednesday 25 April 2012
Notified Bodies and Competent Authorities Panel: Harmonisation and successfully working with Medical Devices Manufacturers
Post-Conference Workshop X: Friday 27 April 2012
Practically implementing Risk Management and Risk Assessment in clinical studies
"Great event with a lot of very helpful and useful information"
"This conference always brings me up to date on the most important topics in Medical Device trials"