Susan Neadle

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

Workshop Day

Tuesday, May 5th, 2020

10:00 AM Workshop A - Hot Topics Discussion

Join this interactive workshop to:
• Address your hot topics and challenges with an industry expert 
• Benchmark with an intimate working group
• Discuss best practices in navigating the regulatory GMP landscape over the end to end lifecycle of your combination products
• Leave with concrete strategies to apply in your everyday role

Conference Day One

Wednesday, May 6th, 2020

9:40 AM Keynote: Risk Management of Combination Products

• Combination Products Regulations are evolving globally, one consistent undercurrent to this dynamic regulatory environment is the drive for success
• Discuss practices and control strategies throughout the combination product lifecycle, to assure public health, ensuring risk is commensurate with product complexity and patient needs
• Review combination products risk management considerations and essential performance requirements to support robust product development and lifecycle management

3:40 PM Interactive Discussion Groups

Use this opportunity to benchmark with your peers and identify the key strategies required to overcome specific challenges. This will run as 2 x 25 minute rotations and a short recap fed back to the group.

1. Industry Elements in Relation to Article 117
2. Application of Design Controls in the Development of Combination Products            

3. Risk Management of Combination Products

Conference Day Two

Thursday, May 7th, 2020

4:00 PM Summative Panel Discussion: Offensive Strategy to Embrace Connectivity for Combination Products

• What are the opportunities and risks for connected devices?
• Will this affect your go-to-market strategy?
• How should you handle post-market surveillance reporting?

Check out the incredible speaker line-up to see who will be joining Susan.

Download The Latest Agenda