8 / 9
Notes:
conference
series LLC Ltd
September 18-19, 2018 | Amsterdam, Netherlands
6
th
European Biopharma Congress
Euro Biopharma 2018
Clinical Pharmacology & Biopharmaceutics | ISSN : 2167-065X
Volume 7
Page 23
Operational and legal challenges for biopharmaceutical and
biosimilar companies conducting clinical trials in Europe
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
maintenance of clinical trial oversight management and the use of effective tools, to
implement a clinical quality management system and to train clinical development
department team. This suggested session should consist of three topics and three
speakers include: Selection of vendors and CROs; legal aspects to conduct clinical trial
in Europe; effective oversight management in clinical trials.
Biography
Heike Schoen is the Managing Director of LUMIS International GmbH, Germany. She is a Cofounder and Managing
Director of LUMIS International GmbH. She has worked in leading positions in clinical research for more than
20 years. Her experience ranges from conducting national and international Phase I clinical trials all the way to
registration and post marketing activities as well as business development within contract research organizations
(CROs) and the biotechnology industry. Her previous positions included Operational and General Management.
She holds a Master’s Degree in Psychology and a Master’s Degree in Business Administration.
heike.Schoen@lumisinternational.comHeike Schoen
LUMIS International GmbH
Germany
Heike Schoen, Clin Pharmacol Biopharm 2018, Volume:7
DOI: 10.4172/2167-065X-C1-027