29 - 31 October, 2018 | Mercure Hotel Amsterdam City, Amsterdam , Netherlands

Florian Tolkmitt


Regulatory Affairs and Clinical Evaluation Expert
Independent Consultant


3:40 PM Compiling a Comprehensive Clinical Evaluation Plan

  • Reviewing the regulatory landscape and how it applies to clinical evaluations for combination products: Recent developments and regulatory strategy
  • Describing the clinical evaluation process and consultation procedures
  • Key considerations for compiling a Clinical Evaluation Assessment report
  • Summary of the Safety and Clinical Performance requirements: Recommendations for combination products

11:10 AM Interactive Roundtable Discussions:

Use this opportunity to discuss key topics with your peers that share similar challenges. Led by our expert facilitators, each roundtable discussion will last for 30 minutes with the opportunity to rotate to a second discussion point.

Roundtable One: Information Management and Design Control to Improving Lifecycle Management 
Facilitator: Margaret Kelly, Device Development Project Leader, Novartis

Roundtable Two: Clinical Evaluations: Challenges, Pitfalls and Solutions
Facilitator: Florian Tolkmitt, Independent Regulatory Affairs and Clinical Evaluation Expert


Check out the incredible speaker line-up to see who will be joining Florian.

Download The Latest Agenda