Thursday, 21 February 2019
5:30-8:30 pm CST
26525 North Riverwoods Blvd
First Floor, São Paulo Conference Room
North Chicago, IL 60064-6220
+1 800 255 5162
Join regulatory professionals from your local area for presentations on these two important topics that cover companion diagnostics and combination products. A companion diagnostic provides information that is essential for the safe and effective use of a corresponding drug or biological product. Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products.
Postmarketing Safety Reporting--Understanding the Draft Guidance: An Industry Perspective
As an industry representative, our speaker will highlight some areas where the guidance appears to have added clarity, and other areas where clarity might still be needed with regards to PMSR requirements. In addition, the presentation will provide an overview of key challenges and suggested solutions that will help your company be more prepared for implementation.
Navigating Regulatory Challenges in the Companion Diagnostic Co-Development Process
The use of companion diagnostics (CDx) has become increasingly common in recent years due to advances in diagnostics and therapies related to oncology, inflammation and autoimmune diseases. Coupled with the benefit of customizing treatment options for individual patients, assuring positive outcomes and avoiding side effects, CDx offers a revolutionary approach to improving patient care. However, the need to have both the drug and device approved for market at the same time and the unique regulatory requirements adds to the complexity of the co-development process. Successful launch of CDx products relies on regulatory professionals who can navigate the challenges exclusive to CDx. The presentation will provide participants with an introduction to CDx and the important issues faced by regulatory professionals working in the CDx space.
This program is brought to you by the RAPS Chicago chapter and is intended to promote knowledge sharing and engagement with others in the local regulatory community. Dinner will be provided and RAC holders may claim three RAC recertification credits.
Khaudeja Bano, MD, head of medical affairs, Abbott Molecular
Vihanga Pahalawatta, PhD, regulatory affairs senior specialist, Abbott Molecular
Prior to 15 February:
On or After 15 February: