Combination Products Summit Agenda: Day 2
Thursday, September 13, 2018

 

7:45 AM - 8:30 AM    

Breakfast

Join your colleagues for a complimentary warm breakfast to jump-start Day 2!


8:30 AM - 10:30 AM    

GMP and Control Strategies

The global industry is working to establish strong quality systems to support the development and optimization of combination products across the total product lifecycle.  In this session, participants will engage in case studies to learn how appropriate risk management practices can lead to a robust and cost effective control strategy that is commensurate with patient risk.  Several examples of successful verification and validation practices will be shared, and experts will provide their unique perspectives and experiences associated with combination product inspections and associated outcomes.

Moderators:

  • Francis Blacha, Global Quality Device Leader, Eli Lilly
  • Susan Neadle, Head, Combination Products CoE and Sr. Director, Design-to-Value and Product Quality Management, Johnson & Johnson

Speakers:

  • Melissa Burns, Senior Program Manager, Office of Combination Products
  • Susan Neadle, Head, Combination Products CoE and Sr. Director, Design-to-Value and Product Quality Management, Johnson & Johnson
  • David Shore, Site Quality Director - Devices, Eli Lilly
  • Alan Stevens, Captain, Branch Chief, General Hospital Devices Branch, DAGHICD, ODE, CDRH (invited)

10:30 AM - 10:50 AM    

Break


10:50 AM - 11:50 AM    

Post-Approval Change Management, Part 1

Once a company receives approval for their combination product, effective change management is vital to ensure continuous supply of the medicine to the patient.  Successful navigation of the post-approval change regulation, guidance and reviewer expectations enables faster time to market following a change. This session is the first part of a two-part session focused on post-approval change management for changes to combination products.  Speakers will provide an overview of the post-approval change management regulatory landscape for combination products, including perspectives related to draft ICH Q12, Technical and Regulatory Considerations for Pharmaceutical Lifecycle Management.

Moderator:

  • Suzette Roan, Senior Director, Global Regulatory Affairs, Sanofi

Speakers:

  • Ashley Boam, Director, Office of Policy for Pharmaceutical Quality, CDER (invited)
  • John McMichael, Combination Products Team Lead, FDA-CDRH/ODE (invited)
  • Chelsea O'Connell, Regulatory Affairs Manager, Amgen

11:50 AM - 1:05 PM    

Lunch Networking by Topic

Sit with FDA officials, speakers, industry experts and your colleagues at tables dedicated to topics that are important to you. Enjoy the discussion with others who share your passion on these topics:

  • Combination Product Inspection Experiences
  • Post-approval Change Strategies
  • cGMP Control Strategies


1:05 PM - 1:45 PM

Post-Approval Change Management, Part 2

This session is the second part of the two-part session focused on post-approval change management for changes to combination products. In this session, participants will work through case study examples of post-approval changes and discuss categorizing changes as well as submission content strategies to support the changes.

Moderator:

  • Suzette Roan, Senior Director, Global Regulatory Affairs, Sanofi

Speakers:

  • Ashley Boam, Director, Office of Policy for Pharmaceutical Quality, CDER (invited)
  • John McMichael, Combination Products Team Lead, FDA-CDRH/ODE (invited)
  • Chelsea O'Connell, Regulatory Affairs Manager, Amgen

1:45 PM - 3:00 PM

Fireside Chat with FDA

In a world of uncertainty as it relates to combination product development, quality system readiness, product approval, evolving regulations and expectations, our FDA panel members will take your questions in an informal, collaborative setting that gets to the heart of your most pressing challenges. Don’t miss this opportunity to engage with FDA and your industry colleagues in a session to remember.

Moderator:

  • Susan Neadle, Head, Combination Products CoE and Sr. Director, Design-to-Value and Product Quality Management, Johnson & Johnson

Speakers:

  • Ashley Boam, Director, Office of Policy for Pharmaceutical Quality, CDER (invited)
  • Melissa Burns, Senior Program Manager, Office of Combination Products 
  • Irene Chan, Commander, Deputy Director, DMEPA, OSE, CDER
  • Laurie Graham, Biologist, CDER (invited)
  • John McMichael, Combination Products Team Lead, FDA-CDRH/ODE (invited)
  • Thinh Nguyen, Director, Office of Combination Products, FDA
  • Alan Stevens, Captain, Branch Chief, General Hospital Devices Branch, DAGHICD, ODE, CDRH (invited)
  • John “Barr” Weiner, Associate Director for Policy, Office of Combination Products, FDA

3:00 PM - 3:30 PM    

To Your Success!

Thank you for joining us, but we insist that you leave with action plans that will enable you to make a difference in your organization and for the patients you serve. Work with your colleagues on turning your learning into a practical action plan.

Moderator:

  • Marla Phillips, Director, Xavier Health, Xavier University

Speaker:

  • Marla Phillips, Director, Xavier Health, Xavier University