Navigating the new FDA world of Combination Products

Why Should You Attend:

It’s no longer just the “drug-eluting stent” that the FDA sees as a combination product, but also the drug being delivered in a pre-loaded syringe, or by a programmable pump. Drug-device interactions need to be specifically tested and the specific compatibility/stability test result information listed in the label.

FDA has increased their level of scrutiny and is adding approval steps for these “combination” products even when the drug and device/s are made by competing companies. What if company a (device) does not want to work with company b (drug) and yet their products are used together (i.e. in “combination”)? Drug and device companies need to be prepared for the added work.

Who is responsible for the testing and why would both companies need to do all the same testing? What additional risk is associated with a combination product? Reporting of adverse events is another complex area. Is it the drug or device that needs to be reported? These are all new questions which need to be addressed since two non-collaborating entities may be involved in bringing a combination product to market.

The FDA published proposed rules for combination products, 21 CFR Part 4, to codify the current good manufacturing practices (cGMP) requirements and Post Market Safety Reporting for combination products and . They are intended to simplify and clarify what submissions are required; however, navigating the current regulatory landscape for combination products is complex and confusing.

During this seminar, you will learn firsthand from Dr. Joy Frestedt’s experience in obtaining successful approvals for combination products and the steps required to get there. She will share insight and tips into how to navigate the world of combination products while working within the proposed rulings.

Areas Covered in the Webinar:

• Introduction to combination products and the established categories of products.
• How the FDA currently views combination products.
• A description of the FDAs proposed rule for cGMP.
• A description of the FDAs proposed rule for Post Market Safety Reporting.
• What is an RFD- Request for Designation?
• The steps involved in the FDAs current process for approving combination products.
• How to eliminate duplication of efforts under for GMP and Adverse Event reporting.
• Suggestions for how to work together to facilitate decision by non-collaborating entities on combination products.
• Tip on strategies for success with combination products.

Learning objectives:

At the end of this training, attendees will be

• Able to describe the broad range of products considered combination products
• Able to find the regulatory requirements for cGMP and safety reporting required for combination products
• Able to list the steps in the approval process for a combination product

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies, including companies in the Medical Device, Biotech, Pharmaceutical, and BioPharma. The employees who will benefit include:

• Senior executives of pharmaceutical and device firms
• Quality Unit Vice Presidents, Directors and Managers
• Vice presidents, Directors and Managers of operations
• Quality engineers and field auditors
• Regulatory and Compliance Management
• Consultants
• Quality System Auditors

Instructor Profile:

Joy Frestedt, PhD, RAC, CCTI is President and CEO of Frestedt Incorporated, a virtual network of 50+ regulatory, clinical and quality experts ( www.frestedt.com ). Dr. Frestedt has 30 years of scientific, clinical and regulatory experience in the health care, pharmaceutical and medical device industries.

She has worked at Johnson and Johnson, Medtronic, Mayo Clinical Trial Services, AstraZeneca, and others. Dr. Frestedt holds a Ph.D. in Pathobiology from the University of Minnesota Medical School. She is a member of ASCO, AAPS, ACRP, and is currently Chair of the Ethics Committee for RAPS.

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