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

Follow Us:

Just published

Proportion of NHS GPs trained in EEA stabilises despite Brexit uncertainty

Proportion of NHS GPs trained in EEA stabilises despite Brexit uncertainty

The proportion of NHS GPs trained in the EEA has stabilised after a steady decline...

GPs split on calls to suspend appraisal for duration of pandemic

GPs split on calls to suspend appraisal for duration of pandemic

Senior GPs are divided over calls for appraisal to be halted for the rest of the...

GP fears rising over covert recording of consultations in pandemic

GP fears rising over covert recording of consultations in pandemic

Fears over patients covertly recording consultations have increased among GPs since...

Coronavirus: Key guidance GPs need to know about COVID-19

Coronavirus: Key guidance GPs need to know about COVID-19

GPonline provides an overview of the key guidance relating to coronavirus, including...

Care home vaccination to begin as Scottish minister says Pfizer vaccine packs can be split up

Care home vaccination to begin as Scottish minister says Pfizer vaccine packs can be split up

Vaccination of care home residents against COVID-19 will start on 14 December in...

How will the COVID-19 vaccination programme get underway?

How will the COVID-19 vaccination programme get underway?

Following the MHRA's approval of Pfizer/BioNTech's COVID-19 jab the government has...