Problem Solving Sessions - Share Solutions and Challenges

We want to offer you the opportunity to bring your challenges/business pains in implementation to the conference and discuss with your peers and assigned experts how to best resolve them.

Question Title

* 1. More Pharma or Biotech companies are having full service CROs subcontract on their behalf to the ancillary vendors. What does this third party outsourcing mean for CROS and for oversight by pharma/Biotech’s?

Submit your case study how you met this challenge.

Question Title

* 2. With the adoption of ICH E6 (R2) - the Addendum to CGP - RBQM in Clinical Development is no longer optional; it has to become an integral part of your clinical quality management system. However: the Addendum is very high-level and conceptual: how are we going to implement this in practice? What can we do? Is there low-hanging fruit? How can we avoid complicating our process? Should be constructing or deconstructing?

In an interactive session we want to share ideas & interpretations of the addendum. Not just to implement - but to embrace RBQM and discover the benefits for Clinical Development. Therefore we need your input. Please share your thoughts, ideas, attempts & issues with the wider community for support & inspiration!

Question Title

* 3. Please provide your name, affiliation and email address. We will then contact you for next steps.

( Privacy & Cookie Notice

T