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

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

Consultations and agency news

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)

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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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