The clinical trial processes will change dramatically in 2019 with the new portal and database - are you ready?
The new Clinical Trial Regulation will shake the business processes of both industry and regulators next year. What do you need to know to be ready from day 1? Our popular Clinical Trial Regulation Conference will:
- Inform on the implementation timelines, interpretation of the regulation by various countries and the European and national level changes
- Benchmark your organisation's progress against other key stakeholders within the sector
- Guide on direction to take with your internal system and process changes
- Give floor to EMA and CTFG to allow you to ask them directly about what is expected.
Make sure you're prepared - don't miss out on the hottest conference of the year.
The programme is foreseen to feature many key regulators from the EMA and CTFG, similarly to the three previous years.
- Updates on the EU portal ahead of implementation in 2019
- Learnings from pilots with rapporteur Member State and harmonised assessment
- Updates on endorsement at Member State-level
- Getting prepared for the Day 1 of the new portal and a new submission process
- Changes in ethics committee structure and reviews
Who should attend?
This conference is aimed at professionals from:
- Regulatory agencies (assessors, reviewers, inspectors)
- The pharmaceutical industry and contract research organisations, including:
- Regulatory affairs personnel in clinical research
- Professionals in charge of clinical trial strategy
- Regulatory intelligence and policy professionals
- Change managers for clinical trials business processes
- Clinical research professionals working with submission, data, information sharing
- Clinical safety professionals
Nick Sykes, MS • Senior Director, Worldwide Safety & Regulatory
Pfizer Ltd., United Kingdom
Surendra Gokhale, PhD • Senior Director, Global Regulatory Affairs and Capability Development Lead
F. Hoffmann-La Roche Ltd, Switzerland
Elke Stahl, PhD • CTFG Co-Chair; Clinical Trial Unit
Federal Institute For Drugs and Medical Devices (BfArM), Germany