TOPRA news

TOPRA advocates Regulatory Affairs Specialist apprenticeship

Posted on 28/03/2019
During the UK National Apprenticeship Week (4–8 March), Samantha Alsbury, TOPRA’s Head of Professional Development, spoke at the Advanced Therapies Apprenticeship Community event on 5 March at Oxford BioMedica, UK.

Chartered Scientist webinar attracts global interest

Posted on 28/03/2019
TOPRA’s first webinar on Chartered Scientist (CSci) was held on 25 February. This webinar aimed to provide attendees all the information they need about gaining professional registration as a Chartered Scientist.

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.

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.

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Brexit news

BEIS updates for the life sciences sector
EMA advises submitting type I variations ASAP
SPC and patent law guidance in a no-deal Brexit
Security for costs post-Brexit
Guidance on MHRA submissions in a no-deal scenario
Businesses not ready for 'no deal' Brexit
HMRC urges businesses to take three steps to prepare for no-deal Brexit
Report: How are the EU institutions and European countries preparing for Brexit ?
No-deal handbook: A practical guide to preparing for a possible no-deal Brexit
Preparing for a no-deal Brexit: videos and webinar
MHRA guidance and publications on a possible no-deal scenario
EU actions to prevent medicine shortages due to Brexit
The Conformity Assessment (Mutual Recognition Agreements) Regulations 2019

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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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