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

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