TOPRA facilitates discussion and learning on SMEs and Scientific Advice

Melanie Carr of EMEA spoke about the progress of the special division for SMEs one year after its creation.  The introduction of the SME classification has resulted in over 100 organisations, recognised as SMEs by the agency, enjoying a reduction in fees of over £2 million.

On the issue of scientific evaluation, value of the Scientific Advice Working Party (SAWP) was explained in detail by Dr Maria Isaac.  She highlighted the increased utilisation of this system by pharmaceutical companies and clinical development programmes.  In response to industry concerns about the system of selection of Rapporteurs and Co-rapporteurs, Anthony Humphreys gave a comprehensive explanation of the protocol as well as CHMP rationale for moving sponsor involvement in Rapporteur selection.

Commenting on the success of the event, TOPRA Executive Director Lynda Wight said, 'This meeting met TOPRA's objectives of providing a forum for open communication and debate between regulators and the industry.  We are delighted to have worked with EMEA once again on this successful event that gave all parties access to new information and opportunities for discussion'

Note to Editor

For further information or comment contact:
Jacob Coy
Cicero Consulting
+44 20 7665 9530

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register

Already registered?

Sign in

Just published

GP on phone in recorded consultation assessment

Consultation skills to help GP trainees pass the RCA

Dr Afsar Rizvi highlights the key skills GP trainees need to master in order to pass...

Wes Streeting

Labour promises same GP 'each appointment' and face-to-face access if patients want it

A Labour government would offer patients the chance to see 'the same doctor each...

Man wearing mask on train

UK faces serious threat from flu and COVID-19 'twindemic' this winter

There are strong indications the UK faces a dangerous 'twindemic' of COVID-19 and...

NHS sign outside a building

PCN contract overhaul defers two-week appointment target until April 2023

NHS England has announced changes to the network contract DES, including deferring...

Coins

NHS sets out priorities for extra GP funding this winter

Integrated care boards could target extra funding for general practice at phone systems,...

Shadow chancellor Rachel Reeves

Labour promises to double medical school places with tax cut reversal

A Labour government would double medical school places with funding raised from reversing...