This article covers some important highlights from the MHRA Good Pharmacovigilance Practise (GPVP) Symposium held in London on 11 February 2020. The symposium provided a mixture of inspector-specific insights through the presentation of trends and metrics from inspection findings, and some...
Read moreIn September 2019 EMA began a review under Article 5(3) of Regulation (EC) No 726/2004 to provide guidance to MAHs on how to avoid the presence of nitrosamine impurities in human medicines. As part of this review, the MAHs were requested to review their authorised human medicines containing...
Read moreDirector / Associate Director Regulatory Affairs Be a key part of a Queen’s Award winning company Work in a smaller company environment with increased visibility and opportunity to make an impact. Member of the management team to develop and grow the company. Diversified role and exposure to a...
Read moreAfter a successful test phase, ANSM has decided to maintain its two accelerated circuits for medicinal product clinical trial authorisations (Fast Track). These circuits were established on 15 October 2018 as an initial test run and on a voluntary basis to reduce clinical trial authorisation...
Read moreAs mandated in Article 4 of Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products (ATMPs), the European Commission has published guidelines on good clinical practice (GCP) specific to ATMPs. The 15-page document should be read in conjunction with ICH E6 Guidelines on GCP , which are...
Read moreNitrosamine impurities were previously detected in batches of medicines containing the Angiotensin-II-receptor antagonist valstartan, leading to worldwide recalls of batches . Since the initial findings, nitrosamine impurities have been detected in some batches of other medicines including the...
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