This webinar series is prepared for you and your team to use as a foundational resource on critical aspects of combination product development, submissions, and on-market safety.

Receive a 15% discount for purchasing all four modules!


Introduction to Combination Products and Quality System Regulations

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

This must-see webinar provides participants with a delineation of how the combination products regulations evolved, the interconnectivity of the drug and device regulations with Part 4, and how to decipher FDA expectations of your facility and products. Establishing a robust quality system will reduce the risk of your combination product to the patients you serve. (Runtime: 00:39:13)


Integrated Development

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

Integrated development of the constituent parts of your combination product is critical to lifecycle success. During this webinar, participants will be introduced to concurrent drug and device development pathways and timelines to help visualize the key activities that meet FDA expectations. (Runtime: 00:42:47)


Submission Strategies and Post-Approval Changes for Drug-Led Combination Products

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

Navigating the FDA combination product premarket submission process and post-approval changes can be streamlined by understanding the steps involved, the timing and timelines, and resources available to you. This webinar will focus on drug-led combination products so you can establish a successful product approval plan in your company today. (Runtime: 00:32:48)


Post-Market Safety Reporting

With Khaudeja Bano, Head Of Medical Affairs, Abbott Molecular Inc.

Complexities of the FDA Final Rule on Postmarketing Safety Reporting can be simplified by understanding the key requirements. During this webinar, you will gain insight on why the requirements were established, and how these requirements can help you establish a dependable postmarket safety reporting system in your company. (Runtime: 00:33:07)