Posted on 24/01/2019
Apprentices have begun signing up for the new Regulatory Affairs Specialist Apprenticeship scheme. Companies who qualify for funding should express their interest.
Posted on 11/02/2019
TOPRA is pleased to announce a collaboration with MedBoard, a single integrated medical device information platform that allows users to access official regulatory information and the latest sector news in a fast, accessible and user-friendly way.
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HPRA: Confirmation dual UK and Irish labels for medicines are acceptable
European Commission: Updated medicinal products FAQ
Data Protection Commission (Ireland): Irish watchdog issues no-deal Brexit data transfers guidance
Department of Health and Social Care - UK: Updated guidance for suppliers of medicines or medical devices in no-deal scenario
Out-Law.com: EURid: Brexit cancellation of .eu domain names confirmed
Out-Law.com: HMRC publishes no-deal Brexit simplified customs procedure
Gov.UK: Regulatory compliance in a no-deal Brexit
BSI: MedTech market access – some clarification from the BSI and Competent Authorities
EMA: Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials (27 Feb 2019)
EMA: Concept paper on the revision of the guideline on the evaluation of anticancer medicinal products (11 Feb 2019)
EMA: Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Categorisation of antimicrobials (4 Feb 2019)
EMA: Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobials (14 Jan 2019)
EMA: Final texts of the new Veterinary Medicines Regulation and the corresponding update of Regulation 726/2004 have been published (7 Jan 2019)
TOPRA Summit 2018 Briefing: TOPRA’s third annual Summit, held on 3 July 2018 in London, focused on how the regulatory profession can remain fit for purpose in a disrupted healthcare system.