TOPRA news

Regulatory affairs apprenticeship applications now open

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.

New medical device collaboration benefits TOPRA members

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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Brexit news

January 2019

MHRA: Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal

MHRA:
 UK to recognise medical device 'CE' marks after 'no deal' Brexit

Out-Law.com:
UK goods face EU transport restrictions if post-Brexit competition is not 'fair'

Gov.uk:
UK government guidance on how to prepare if the UK leaves the EU with no deal 

Out-Law.com:
Brexit response: Irish drugs regulator loosens packaging rules

Out-Law.com:
UK goods face EU transport restrictions if post-Brexit competition is not 'fair'

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Consultations and agency news

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)

EMA: Regulatory Science to 2025 – Launch of six-month public consultation (19 Dec 2018)

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Papers

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.

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