Amanda Matthews

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

Conference Day One

Wednesday, May 6th, 2020

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

9:50 AM Case Study: ISO 20069 Change Management Standard

• Be provided with an overview of the standard itself and what it encompasses 
• Consider the standard to ensure effective change management in relation to key aspects for managing change through the product lifecycle
• Review other guidance consideration for change management 

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

Download The Latest Agenda