22 - 24 October, 2019 | Mercure Hotel MOA Berlin, Berlin, Germany

Main Conference Day Two

8:30 am - 9:00 am Registration and Coffee

Susan Neadle, Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design at Johnson & Johnson

Susan Neadle

Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design
Johnson & Johnson

9:10 am - 9:40 am Integrating Post-Market Surveillance Throughout The Lifecycle

  • Understand why it’s important to interlink post market surveillance into all stages of the lifecycle 
  • Identify why internal communication strategies are crucial for effective lifecycle management
  • Learn the best practices to prepare for the EU MDR
Kirsten Paulson, Sr. Director, Global CMC-Medical Device Lead at Pfizer

Kirsten Paulson

Sr. Director, Global CMC-Medical Device Lead
Pfizer

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

Milena Roux, Regulatory Professional at Novo Nordisk

Milena Roux

Regulatory Professional
Novo Nordisk

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?

Ola Oyinloye, Associate Director, Medical Devices and Combination Products at AstraZeneca

Ola Oyinloye

Associate Director, Medical Devices and Combination Products
AstraZeneca

Jane Wilson, Product Safety Manager at Owen Mumford

Jane Wilson

Product Safety Manager
Owen Mumford

Amanda Matthews, Sr. Director, Regulatory CMC for Combination Products & Medical Devices at Pfizer

Amanda Matthews

Sr. Director, Regulatory CMC for Combination Products & Medical Devices
Pfizer

Margaret Kelly, Device Manager - Processes at Novartis

Margaret Kelly

Device Manager - Processes
Novartis

11:10 am - 11:40 am Networking Coffee Break

11:40 am - 12:10 pm Typical Challenges Faced After The Launch Of Your Product

  • Understanding the changing regulatory landscape once you have launched your combination product
  • Identify the consequences of post-market surveillance
  • Discuss site transfers and the common challenges faced 

Thomas Fischer, Head Quality Medical Device Development at Novartis

Thomas Fischer

Head Quality Medical Device Development
Novartis

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

Justin Metcalf, Associate Director, Global External QA Operations at Alkermes

Justin Metcalf

Associate Director, Global External QA Operations
Alkermes

1:00 pm - 1:40 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!

1:40 pm - 2:40 pm Networking Lunch

2:40 pm - 3:20 pm Nonclinical Safety Requirements For Registration Of DDCP

  • Understanding the complexity of nonclinical safety requirements for DDCP
  • Discover how to perform biocompatibility testing according to ISO-10993
  • Select an appropriate test strategy to avoid potential pitfalls

Clemens Günther, Director, Nonclinical Safety Customer Care at Bayer

Clemens Günther

Director, Nonclinical Safety Customer Care
Bayer

3:20 pm - 4:00 pm Improving Medical Device and Pharma Team Collaboration

  • Overcome the common pitfalls usually experienced within the combination product life cycle
  • Learn how to apply your area of specific expertise and adapt to speak each other’s language 
  • Review your shared goals to ensure you’re working as one team
Chris Minnich, Device Project Director at Merck Group

Chris Minnich

Device Project Director
Merck Group

  • 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?

Khaudeja Bano, Head of Medical Affairs at Abbott Molecular

Khaudeja Bano

Head of Medical Affairs
Abbott Molecular

Susan Neadle, Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design at Johnson & Johnson

Susan Neadle

Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design
Johnson & Johnson

Jane Wilson, Product Safety Manager at Owen Mumford

Jane Wilson

Product Safety Manager
Owen Mumford

Amanda Matthews, Sr. Director, Regulatory CMC for Combination Products & Medical Devices at Pfizer

Amanda Matthews

Sr. Director, Regulatory CMC for Combination Products & Medical Devices
Pfizer

4:40 pm - 5:10 pm Networking Coffee Break

Susan Neadle, Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design at Johnson & Johnson

Susan Neadle

Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design
Johnson & Johnson