Heike Schoen
LUMIS International GmbH, Berlin, Germany
Title: Operational and Legal Challenges for Biopharmaceutical and Biosimilar companies conducting Clinical Trials in Europe
Biography
Biography: Heike Schoen
Abstract
The implementation of the new ICH E6 R2 GCP guideline has created confusion, contradictory opinions about what is necessary to be implemented as Sponsor oversight in clinical trials to fulfill the requirements. Sponsor oversight in general is not new, of cause, but the details to mandatory perform oversight activities and to manage compliance for all clinical trial activities have raised lots of discussions with different opinions and solutions.
One important step in Sponsor oversight is the selection and management of CROs and vendors. The key in CRO/vendor-selection is not only the experience with the specific indication of the CRO, however of same importance is to consider the company cultures to achieve the best alignment within the two or more parties and to define clear responsibilities and expectations.
Finally when it comes to define the different involvement of the stakeholders in a clinical trial the legal aspects have to be carefully considered, not only for the sponsor-vendor relationship but also the site contracts and the different requirement of the respective countries within Europe.
Another challenge for the majority of the smaller sponsors is the set up and maintenaince of clinical trial oversight management and the use of effective tools, to implement a clinical quality management sytem and to train clinical development department team.