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
‘Tis the Season . . . to Prepare for Phase 2 HIPAA Audits
Though the U.S. Department of Health and Human Services Office for Civil Rights (OCR) has told organizations to expect the Phase 2 HIPAA audits soon for almost two years now, it appears that the audits truly are around the corner.
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