Combination Products Approval Operations with Art Faulkner


Art Faulkner, VP, Regulatory CMC at TG Therapeutics, is one of many distinguished presenters at this year’s 4th Annual Regulatory Affairs CMC: Chemistry, Manufacturing, and Controls Conference. His presentation “CMC Regulatory Guidelines Impacting Combination Product Approval Operations” will provide clarification on the regulation and submissions for combination products. Check out a preview of his presentation below.


Can you please describe your job function and responsibilities?

I am responsible for the development and execution of regulatory CMC strategy to support the global registration of new drug products. I work closely with pharmaceutical, clinical and non-clinical development teams to provide guidance that ensures compliance with regulatory CMC requirements.


Can you give a brief summary of your presentation?

I plan to discuss the regulatory requirements for drug/device combination products. I will provide examples of documentation that is required to support registration and qualification of combination products. Additionally, I will clarify situations when the required documentation differs, and the mechanism to classify combination products.


What are three key points you plan to cover?

I will cover regulatory requirements combination products, how the requirements differ for various categories of combination products and the mechanism to classify a combination product.


What do you hope is one thing attendees walk away from your presentation knowing?

Attendees will have a clear understanding of how to establish documentation and GMP requirements for various combination products and how to classify products in development.


To learn more about combination products and their approval operations register for Q1’s 4th Annual Regulatory Affairs CMC: Chemistry, Manufacturing, and Controls Conference hosted in Philadelphia on October 29-30! Download the agenda today for information on other topics, speakers and sessions featured.