Sr. Director, Regulatory CMC for Combination Products & Medical Devices
Main Conference Day Two
Thursday, October 24th, 2019
10:30 AM Roundtable Discussions:
Use this opportunity to benchmark with your peers and identify the key strategies required to optimise your lifecycle management process, from concept to market. Use this 40 min opportunity to discuss your chosen topic and benchmark with your peers.
- Regulatory intelligence in the emerging market and outside of the EU
- Interpreting risk management requirements
- Ensuring multi-functional stakeholders are bought in to the life cycle
- Organization of product information – what goes into the DHF and what does not?
- How can you improve the collaboration to optimise your processes?
- Uncover the differing terminology and understand how this will boost your productivity
- What are the biggest challenges you anticipate and what will be the impact of the EU MDR?