22 - 24 October, 2019 | Mercure Hotel MOA Berlin, Berlin, Germany
Main Conference Day Two
8:30 am - 9:00 am Registration and Coffee
9:00 am - 9:10 am Chairwoman's Opening Remarks and Welcome
Susan Neadle
Head, Combination Products CoP and Sr. Director, Global Value Chain Quality DesignJohnson & Johnson
9:10 am - 9:50 am MHRA Perspective: Understanding The Regulatory Landscape For Combination Products
- Gain understanding of MHRA’s definition of a Combination Product
- Determine the information required and hear insight on what is the agency’s point of view
- Discuss guidelines that are being introduced and plans for the future of combination product development
9:50 am - 10:30 am Lifecycle Management And Registering Products Across The Globe
- Understand the regulatory requirements for your combination product as a whole
- Review the transition between the medical device directive and the upcoming EU MDR
- Learn how regulations differ across the globe and how you can alter your strategy to adapt to this
- Discover how the registration process differs in China with case study insights
10:30 am - 11:10 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?
Amanda Matthews
Sr. Director, Regulatory CMC for Combination Products & Medical DevicesPfizer
11:10 am - 11:40 am Networking Coffee Break
11:40 am - 12:20 pm Case Study: Devices in a Pharma Company
- Discuss the challenges with design control and device development/maintenance within a pharma company
- Understand the process of marrying a pharma organisation with the device organisation to develop and maintain the product
- Identify business gates and procedures involved
12:20 pm - 1:00 pm Implementing Combination Products Guidance For a Legacy Product
- Discover the background on current process and what this means for your quality system
- Guarantee the smooth implementation of combination products guidance by designing a preparatory strategy, including gap assessments
- Reflect on case studies and lessons learned to ensure compliance goals are met
1:00 pm - 2:00 pm Networking Lunch
2:00 pm - 2:40 pm The Solution Room
This interactive troubleshooting session is designed to give peer-supported advice and will target key challenges that surround combination products. Delegates and solution providers will split into small teams and take it in turns to present their biggest problem and have it brainstormed by the group to come up with solutions!
2:40 pm - 3:20 pm The FDA Regulatory Landscape
- Discuss the regulation of other combined uses of medical products in the US
- Address policy developments from pre-market through post market, including topics on pathway availability, key review issues such as bridging and human factors, CGMPs and post market safety reporting
- Consider regulatory issues relating to combined use products more broadly, including software and technology enabled devices intended to enable and enhance safe and effective prevention, diagnosis and treatment
3:20 pm - 4:00 pm Summative Panel: Pharma and Medical Device Collaboration
Moderators:
Khaudeja Bano Head of Medical Affairs Abbott Molecular
Susan Neadle Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design Johnson & Johnson
Jane Wilson Product Safety Manager Owen Mumford
Amanda Matthews Sr. Director, Regulatory CMC for Combination Products & Medical Devices Pfizer
Khaudeja Bano Head of Medical Affairs Abbott Molecular
Susan Neadle Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design Johnson & Johnson
Jane Wilson Product Safety Manager Owen Mumford
Amanda Matthews Sr. Director, Regulatory CMC for Combination Products & Medical Devices Pfizer
- 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?
Susan Neadle
Head, Combination Products CoP and Sr. Director, Global Value Chain Quality DesignJohnson & Johnson
Amanda Matthews
Sr. Director, Regulatory CMC for Combination Products & Medical DevicesPfizer
4:00 pm - 4:10 pm Chairwoman's Closing Summary and End of Day 2
Susan Neadle
Head, Combination Products CoP and Sr. Director, Global Value Chain Quality DesignJohnson & Johnson