Tutorial: October 28th - Combination Products: A Comprehensive Overview of Premarket Opportunities and Postmarket Challenges!
Meeting: October 29th
Travel Once, Learn Twice and Save
Save when you register for both the DIA Meeting on Combination Products
and the DIA Meeting on Companion Diagnostics
*You must register for both events at the same time.
Advances in scientific knowledge and technology are driving growth and innovation for combination products. Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products.
Because combination products involve components that would normally be regulated under different types of regulatory pathways, and frequently by different FDA Centers, they may raise challenging policy, regulatory, and review management issues. Differences in pathways ordinarily associated with each component can raise questions for all aspects of product development and management, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, and post-approval modifications.
This conference will provide a practical approach to development processes and regulations in this evolving landscape. The day will focus on:
*LATE BREAKING SESSION JUST ADDED!
This evening session is included in the Combination Products and Companion Diagnostics program registrations.
October 29, 2014
5:30 to 7:00 PM
Washington Marriott Wardman Park
If you can’t attend the Combination Products or Companion Diagnostics meetings but want to hear the LDT discussion, register for this evening session for just $99! Register now!
LATE BREAKING SESSION: The recent FDA draft guidance, Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), proposes a risk-based framework for FDA regulatory oversight of a subset of in vitro diagnostics (IVDs) referred to as laboratory-developed tests (LDTs). FDA’s pre- and post-market requirements for IVDs would apply under certain circumstances to LDTs developed in laboratories, which are also regulated under the Clinical Laboratory Improvement Amendments (CLIA).
The importance of investigational tests, including LDTs, to diagnosis and treatment decisions is increasing, especially with the advancement of personalized medicine and companion diagnostics. Stakeholders agree that the tests, regardless of their source, must be analytically and clinically valid as well safe for patients.
What impact will the FDA oversight have, and where are the overlaps and potential conflicts with CLIA regulation? What is the most effective means of assuring clinical validity of LDTs? Will approvals under the proposed framework be able to keep pace with technology based advances in testing? How can patient safety be best balanced with innovation?
These and other questions will be discussed in depth from the perspectives of regulators, diagnostics developers, laboratories, and pharma sponsors.
DIA is hosting a related one-day meeting on Companion Diagnostics on October 30th.