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Chapter Webcast: Best Practices for Management of Companion Diagnostics (CDx) Partnerships (On-Demand)

On-demand On-demand Member: $0 NonMember: $25


Chapter Webcast: Best Practices for Management of Companion Diagnostics (CDx) Partnerships (On-Demand)

This is an On-demand recording from June 2022.

The co-development of Therapeutics and Companion Diagnostics requires the careful navigation of technical and regulatory milestones, timelines and regulatory hurdles which could at any point hinder or delay the approval of one or both of the products.  The success of the co-development program hinges on the effective management partnership of the therapeutic developing company and the diagnostic developing company. However, there are often practical, tactical and cultural large differences between therapeutics and diagnostics companies which can set the progress astray. This program will cover the key elements and strategies for effective management of Companion Diagnostics.  The program will review:

  • Setting the stage for success: Quality Agreements and Development Agreements
  • Critical to Quality (CTQs) Attributes
  • Regulatory Meeting and regulatory communications
  • Managing Stakeholder Expectations (both ways)
  • Best practices and common mistakes to avoid in CDx Programs

The program will also review some key elements of CDx Partnership including how existing IVDs can be leveraged in Therapeutics Development programs, stop-gates and key requirements in the development of the program.

The program will conclude with a few case studies that exemplify how the recommendations can be implemented.


Registration Fees & Deadlines

Member: $0 | NonMember: $25


Instructors:

TJ Thiel

TJ Thiel is a Senior Director for PharmaLex Australia a division of PharmaLex, a global regulatory, quality and strategic advisory firm. He has worked in quality and regulatory affairs in the Australian, US and European medical device and diagnostics industries for more than 20 years. From major multinationals to small start-ups, TJ has deep experience with global regulatory approvals and registration, providing clients with planning and strategy suitable for both local and world-wide product launches.


Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the webcast.

Questions

Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org

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