CDER, CDRH and ORA are going through dramatic changes:

  • Different timelines
  • Different drivers
  • Different organizational structures
  • Different execution
  • Different impact on pharmaceutical and medical device firms

Through this live web conference, we will bring all the alignment and reliance initiatives together to increase your understanding of the bigger picture, so you can better collaborate with FDA and understand how to navigate through these changes for the success of the patients you serve.

Cost:

  • Cincinnati Regional Chapter members: Free
  • Non-members:  $595
  • Government officials: Free (register as Government)
  • Media: Free (register as XU Guest)
 

Half Day with FDA Agenda

8:00 am – 8:15 am

Welcome Remarks

As you are welcomed to the Xavier experience, understand more fully how you can lead your organization through deeper insights on the “why” behind the future direction of your industry.


Speaker: 

  • Marla Phillips, Xavier University

8:15 am – 9:00 am

The Power of Mutual Reliance

Regulators around the world are faced with the same challenge:  not enough investigators to inspect the rapidly growing number of pharmaceutical companies. In order to protect the public they serve, regulators need to approve products entering their market from vastly complex global supply chains. Although risk-ranking is one tactic that helps focus inspectional resources on the greatest need, perhaps the most powerful answer is reliance on the inspections of other global regulators. 

Key takeaways from this session:

  1. Understand the importance of why mutual “recognition” was transitioned to mutual “reliance.”
  2. Learn the status and timeline of the Mutual Reliance Initiative, and the impact it has to your organization.
  3. Identify the greatest challenges to mutual reliance, and how regulators are working to overcome those challenges.
  4. Gain advice from the FDA on how to prepare your company.

Speakers: 

  • Dara Corrigan, Office of the Commissioner (invited)

9:00 am – 9:45 am

Medical Device Single Audit Program (MDSAP) in Action

Similar to the challenges discussed in the pharmaceutical industry, regulators are working to increase their inspectional coverage of medical device firms around the world by collaborating with other global regulators. As the number of imports of medical devices and device component import into the United States are drastically increasing, regulators are responding rapidly to expand their ability to protect the public.

Key takeaways from this session:

  1. Understand the status of the MDSAP program, and important dates on the timeline that will impact your organization.
  2. Learn what barriers have been identified as perceived and real, and how regulators are addressing those challenges.
  3. Ascertain how the MDSAP process works, including inspection resolution.
  4. Gain advice from the FDA on how to prepare your company.

Speakers:

  • Neil Mafnas, CDRH
  • Melissa Torres, CDRH (invited)
  • Marc-Henri Winter, CDRH


9:45 am – 10:00 am

Break


10:00 am – 10:30 am

Total Product Lifecycle (TPLC) Realignment within CDRH

CDRH is working to align its workforce to better support the rapidly evolving technical innovation of industry. The Total Product Lifecycle Realignment cuts across all CDRH operations, and impacts every aspect of your product development, approval, and commercialization.

Key takeaways from this session:

  1. Understand how CDRH is realigning, and what has driven the need for this effort.
  2. Learn how your organization will be impacted throughout your product development, approval and commercialization.
  3. Gain advice on how best to collaborate with CDRH to promote and protect patient health.

Speakers: 

  • Sean Boyd, CDRH

10:30 am – 11:00 am

Case for Quality – CDRH Strategic Priority with Industry

CDRH has been working closely with industry professionals since 2011 to shift the industry and FDA approach to compliance. The foundational concept is to shift the focus to quality excellence, which will naturally result in compliance, rather than focusing on how to avoid enforcement. Understand how your organization can benefit from this approach, as well as participate in the development of future operations. CDRH will share how the development of a maturity model assessment can level the playing field and drive efficiencies in your organization.

Key takeaways from this session:

  1. Understand how the CDRH and industry are working together to develop a maturity model approach to risk assessment. 
  2. Obtain insight on what CDRH and industry have learned through initial pilot studies.
  3. Gain advice from FDA on how to best to collaborate with FDA in the development of the maturity model approach.

Speakers: 

  • Francisco Vicenty, CDRH

11:00 am– 11:50 am

Program Alignment and Concept of Operations - FDA Office of Regulatory Affairs (Field Operations) 

With so many operational changes within the agency that include realignment and collaboration with global regulatory authorities, learn how the centers and field operations will be working together to best protect the patients you serve. As ORA aligns by program (essentially, by commodity), they will have subject matter experts working with you to ensure the quality of your product is fit for use. Also, learn how the Concept of Operations will be put into action prior to your product approval and beyond.

Key takeaways from this session:

  1. Understand the “why” behind the changes related to Program Alignment, and how this impacts your organization.
  2. Learn how Program Alignment impacts the interfaces with CDER and CDRH, as well as foreign inspection operations.
  3. Gain advice from FDA on how best to navigate the newly-aligned field operations when you have questions and concerns.

Speakers: 

  • Ellen Morrison, ORA (invited)


11:50 am – 12:00 PM

Closing Remarks

Xavier University is committed to Making a Difference with and for the pharmaceutical and medical device industries and the patients you serve. Be sure to capture the key takeaways and develop action plans to go make a difference!

Speaker: 

  • Marla Phillips, Xavier University

12:00 PM – 1:30 PM

Post-Conference:  Cincinnati Regional Chapter Discussion Forum

Members of the Cincinnati Regional Chapter will participate on campus in the live web conference, which will end with a question and answer session, identification of key takeaways, and an exchange of successful practices that can be implemented today. (Lunch will be provided).

Speakers: 

  • Marla Phillips, Xavier University
  • Michelle Rich, Xavier University

Half Day with FDA Speakers