TOPRA news

Q&A with TOPRA's first president on the organisation's 40th anniversary

Posted on 13/11/2018
To mark 40 years since the British Institute of Regulatory Affairs Constitution was signed – the birth of what is now known as TOPRA – we speak to Brian James, TOPRA's first president, about how the profession and TOPRA have evolved.

2018 TOPRA Awards winners crowned

Posted on 02/11/2018
Winners of the TOPRA Awards for Regulatory Excellence 2018 were announced last night (1 Nov) at a ceremony in London, UK. The Awards celebrate the achievement of individuals, teams and organisations in the wider RA community.

TOPRA congratulates 2018 MSc graduates

Posted on 02/11/2018
TOPRA would like to congratulate this year’s MSc in Regulatory Affairs graduates, who were announced at the dinner ceremony of the TOPRA Awards for Regulatory Excellence on 1 November in London.

2019 TOPRA Board announced

Posted on 10/10/2018
New members of TOPRA’s Board of Directors were announced at the organisation’s 2018 Annual Review Meeting, held on 2 October in Stockholm, Sweden, in conjunction with TOPRA's Annual Symposium.

TOPRA Summit: Briefing now available

Posted on 22/08/2018
TOPRA’s third annual Summit, held on 3 July 2018 in London, UK, focused on how the regulatory profession can remain fit for purpose in a disrupted healthcare system

TOPRA offers degree accreditation programme

Posted on 01/08/2018
TOPRA is delighted to announce the opening of its degree accreditation programme to recognise and promote the teaching of regulatory affairs at undergraduate level.

TOPRA Brexit roundtable outlines challenges for clinical development of pharmaceutical products

Posted on 24/07/2018
Delegates from healthcare regulatory affairs and interested stakeholders gathered on 19 July at TOPRA’s offices in London to discuss the challenges Brexit will place on research, development and supply of medicinal products.

Be prepared for 'hard' Brexit, delegates at TOPRA Roundtable told

Posted on 18/06/2018
Regulatory affairs professionals and stakeholders met on 14 June 2018 at TOPRA’s headquarters in London to discuss challenges facing the profession as Brexit approaches.

Regulatory affairs apprenticeship standard approved

Posted on 06/06/2018
TOPRA-facilitated regulatory affairs apprenticeship standard approved by UK's Institute for Apprenticeships.

TOPRA holds medical devices-focused Brexit roundtable

Posted on 24/05/2018
First TOPRA Brexit Roundtable on medical devices examines how the impact of the UK leaving the EU could be mitigated held in London.

Why diversity matters

Posted on 21/05/2018
On World Day for Cultural Diversity for Dialogue and Development 2018 (21 May), Aman Khera, a member of TOPRA’s Diversity Committee, explores diversity and inclusion in regulatory affairs as a driver for advancing healthcare.

Drug approvals in EU and US for SMEs exceed big pharma in 2017

Posted on 17/05/2018
Consulting group finds that SMEs made up 51% of new drug approvals in the EU an US in 2017, compared with 49% from big pharma.

CPD certificate for 2017 now available

Posted on 26/04/2018
TOPRA members can now download a certificate of their continuing professional development (CPD) activities in 2017.

First TOPRA members achieve chartered scientist status

Posted on 29/03/2018
TOPRA is delighted to announce that the first TOPRA members to achieve recognition as chartered scientists since TOPRA began offering certification to members in January 2018.

TOPRA statement on UK Select Committee Brexit report

Posted on 22/03/2018
TOPRA lauds UK Government's Health and Social Care Committee for advice on continued alignment with EU regulatory regimes for medicines, medical devices and substances of human origin.

TOPRA delivers first training programme in Malta

Posted on 22/03/2018
TOPRA recently held its first training programme in Malta for regulatory professionals in collaboration with the Maltese Medicines Authority.

A message from TOPRA President Angela Stokes

Posted on 06/01/2018
We're expanding our efforts to help regulatory affairs professionals stay current in an ever-changing environment.

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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  (3 Jan 2019)

MHRA: UK to recognise medical device 'CE' marks after 'no deal' Brexit  (9 Jan 2019)


Consultations and agency news

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)



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.