- Medical_Professionals
- Medical_students
- Nurses
9th Annual Clinical Forum and Exhibition 2016
Clinical Data, Clinical Operations and Statistics are highly dynamic groups in the clinical development arena. Particularly 2016 will bring important changes in the European regulatory framework once the ICH E6 Addendum kicks in. At that time ‘Quality’ is no longer the outcome of well-designed processes, but it should be an explicit and very well-considered strategy in the way we design our processes and studies. Risk-Based Monitoring will be codified in Good Clinical Practice, and many organisations will have to revisit their Standard Operations Procedures, processes and study-related documents. And obviously, this will have an impact on the roles of professionals working in clinical development.
In three parallel themes, changes and developments within Clinical Data, Clinical Operations and Statistics will be addressed. During a joint plenary session, topics that bind both groups will be discussed: Risk-based Monitoring, the status of eSource and independent 3rd parties, and Quality Management in Outsourcing.
Problem Solving Sessions - Share Solutions and Challenges
The Clinical Forum is piloting a new type of interactive session. 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:
More Pharma or Biotech companies are subcontracting full service CROs. What does this third party outsourcing mean for CROs and for oversight by pharma/biotechs and which challenges are you facing? (Will be discussed in Session 1)
With the adoption of ICH E6 (R2) - the Addendum to CGP - RBQM in Clinical Development is no longer optional. Which challenges are you facing during the implementation of RBQM into the clinical quality management system. (Will be discussed in Session 4)
EUR
2016-08-18
Group registrations not allowed
Accompanying persons not allowed
We don’t accept Online Abstracts
Hilton Dusseldorf
Georg-Glock Strasse 20, D-40474,
Dusseldorf,
Germany
Submission Info
REGISTRATION QUESTIONS
Send Email
+41 61 225 51 51
AGENDA AND LOGISTICS
Send Email
+41 61 225 51 49
REGISTRATION QUESTIONS
Send Email
+41 61 225 51 51
AGENDA AND LOGISTICS
Send Email
+41 61 225 51 49