Sanjay Jain

Associate Engineering Director, Device Janssen

Workshop Day

Tuesday, May 5th, 2020

2:00 PM Workshop B - Using Design Controls to Aid in the Development of Combination Products

Join this interactive workshop to:
• Document the structure and basic principles that aid in project planning, development, execution and life cycle management
• Gain an understanding of the rules and regulations, and merging pharma and medical device
• Explore using quality systems to develop combination products 
• Discuss the synergistic effects between device mode of actions and drug mode of action and their impacts on development plan
• Review a hypothetical product to come up with a development plan – what are the key elements that need to be incorporated?
• Leave with an understanding of how design controls influence development 

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

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

Download The Latest Agenda