The requirement of a European Legal Representative (LR) for clinical investigations is seen in DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of Good Clinical Practices in the conduct of clinical trials on medicinal products for human use.
The responsibilities associated with the role as European LR vary, with the greatest responsibility being complete liability.
MedPass Limited provides a full European LR service offering immediate access to experienced multilingual professionals providing expert assistance throughout the duration of the clinical trial.
Data Protection Representative
The General EU Data Protection Regulation (GDPR) came into effect on 25 May 2018, requiring non EU companies (that are required to comply with the GDPR) to appoint an EU Data Protection Representative (DPR).
MPLR SAS, provide a full European DPR service for clients where we are actively involved in their studies.