EU Clinical Trial Regulation: Get Ready. Set.
Published Date: Jan 01, 2021The European Union Clinical Trial Regulation 536/2014 (EU-CTR) aims to standardize and harmonize the conduct and management of interventional clinical trials across the European Economic Area (EEA), with legally binding rules on requirements and increased transparency, and goes into effect in December 2021.
Author(s)
Dr. Ruediger Pankow
Principal Consultant, Regulatory Affairs
Parexel International
Ruediger Pankow is currently Principal Consultant Regulatory Affairs at Parexel where he has 13 years Contract Research Organization experience in global clinical trial application management, oversight and Regulatory consulting. As ACRO representative for the EU Scientific and Regulatory Committee he has been involved in all user acceptance testing of the Clinical Trial Information System (CTIS) and other EMA stakeholder activities for the EU Clinical Trial Regulation. Since 2019 Ruediger has been one of the stakeholder association representatives (for ACRO) acting as Sponsor Product Owners in the EMA new delivery model for the CTIS development.
Mr. Danu Pamungkas
Principal Consultant
Parexel Netherlands BV
Dr. Beate Roder
Director
PAREXEL International
Biologist with 17 years of experience in the pharmaceutical industry and CROs. Strong expertise in managing multi-national clinical trials under operational and regulatory aspects. Hands-on experience with clinical trial applications and coordination for multi-national clinical trials.
Ms Bettina Goldberg
Vice President Regulatory
Parexel International GmbH