22 - 24 October, 2019 | Mercure Hotel MOA Berlin, Berlin, Germany
Ola Oyinloye
Associate Director, Medical Devices and Combination Products
AstraZeneca
Main Conference Day One
Wednesday, October 23rd, 2019
1:00 PM Regulatory Intelligence: Influence on Strategy Development
- Explore how you can take your combination product beyond the US and EU markets
- Understand the differing submission requirements for combination products in countries such as China, Malaysia and South Korea
- Identify the documentation must be submitted in order to remain compliant
- Understand how regulatory intelligence can be incorporated into your product and processes
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?