FDAnews’s first-ever all-day conference on combination products will feature 17 experts from from every background — drugs, devices, biologics, generics, regulatory, legal, consulting and more. Tor Alden, Principal/CEO of HSD, will be speaking as part of a panel on Human Factors Studies of Generic Combination Products with Device Delivery Constituent Parts. The panel will focus on the key to obtaining FDA approval; by validating that a generic drug delivers the same amount of active ingredients as the reference listed drug. For a generic combination product, a human factors study may be needed to show that the device delivery constituent part does not impact drug delivery. The panel will discuss the important considerations in such a study.
Tor Alden will join a panel with Kristen Paulson – Senior Director, Clobal CMC-Medical Device, Pfizer, and Dick Horst – President of User Works, Inc. discussing human factors studies for Combination Products.
“Human Factors Study of a Generic Combination Product with a Device Delivery Constituent Part: When Is It Needed and How to Conduct One” Session is at 2:15pm on June 8, 2017. Register for the Conference at FDAnew’s website.
About FDAnews Conference:
The Conference will benefit those involved with the day-to-day activities of combination product design, development, validation and production within quality, regulatory, laboratories, engineering, R&D and operations organizations. You will be able to:
- Adopt three successful tactics and strategies for obtaining jurisdictional determination, assuring certainty with submission requirements, and overcoming barriers to combination product approval
- Understand postmarket safety reporting and current good manufacturing practices requirements for combination product and constituent part sponsors to better enable you to stay in compliance with agency mandates
- Comply with the unique considerations for advertising and marketing your combination products
- Know the three critical findings of a human factors study of a generic combination product with device delivery constituent part
- Implement three best practices for submitting combination products directly to CDRH and understand three important implications of the Cures Act on these submissions
The Conference is on June 8, 2017 at the Law Offices of King and Spalding LLP in Washington D.C.