After 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 moreSenior Regulatory Affairs Consultant Your tasks You are part of our international Regulatory Affairs team and report directly to the business directors As a team leader, you will be supervising Regulatory Affairs Managers and Assistants and ensuring the quality of the project work You coordinate...
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...
Read moreFrom the 21st to the 24th of September, EUDRAC will be exhibiting at the RAPS Convergence 2019 in Philadelphia, Birthplace of the USA. Our team’s experts cover a vast spectrum of expertise, ranging from Small Molecules to Advanced Therapies, and from successful Dossier submissions to the...
Read moreAssociate Director, Regulatory Affairs Be part of our award-winning team South Oxfordshire, UK Full time or Part time (4 days) Permanent contract, competitive salary plus benefits Not your average RA role Are you looking to diversify your role and be exposed to a variety of therapeutic areas and...
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