On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
Hogan Lovells Issues Sponsored Research Alert on Proposed Changes to Federal Policy for Protection of Human Subjects
The NPRM would substantially change, in several respects, the regulatory framework with which universities and research institutions have had years of experience. For example, if an institution receives federal funding for human subjects research, all clinical trials at the institution would become subject to the Common Rule. New rules would govern research use of biospecimens, and new elements of informed consent would prompt substantive and procedural modifications to current practice. The NPRM also implicates questions such as how institutions manage risk in multi-site studies if such studies are to be reviewed, as the proposal suggests, by a single Institutional Review Board (IRB).
To view the alert, please click here.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017