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Positive Feedback on SRA Initiative from Multiple European Stakeholders

The strategic research agenda (SRA) received overwhelmingly positive feedback during the MSCG meeting on March 20, 2006. Responses came from various countries including Austria, Denmark, France, Germany, and more. Stakeholders such as EMEA-CHMP and organizations like IVTIP and EUFEPS expressed strong support. Comments emphasized the initiative's ambition, its alignment with academic goals (as noted by France), and its potential contributions from nations like Sweden and the UK. However, concerns about IPR issues, timeframes, and the need for stronger SME involvement were also highlighted.

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Positive Feedback on SRA Initiative from Multiple European Stakeholders

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  1. IMIComments on SRA (version July 2005) MSCG meeting 20 March 2006 Bernd Rainer

  2. Concerted Feedback/Input on SRA received from: • Austria, Denmark, France, Germany, Hungary, Ireland, The Netherlands, Poland, Sweden, UK, Romania, Turkey, Norway.

  3. Additional input on SRA from: • EMEA - CHMP - COMP • In-vitro-Technology Industrial Platform (IVTIP) • European Federation of Pharmaceutical Sciences (EUFEPS) • ClinPharm Int. GmbH (CRO) • Univ. Bologna

  4. Overall feedback:very positive • France: “INSERM and its academic partners.. are strongly supportive of this initiative.” • Ireland: “The initiative is worthwhile and sound.” • The Netherlands: “….in general we welcome this initiative.” • Norway: “An ambitious research agenda which addresses important topics with well coordinated plans” • “Sweden has a strong potential to contribute to the realisation of PPPs, as the initiative suggests.” • “UK enthusiastically supports IMI's priorities and is delighted that they have been agreed across a wide group of stakeholders.“ • EMEA-CHMP: “The document is ambitious and most of the points well taken.”

  5. Safety

  6. Efficacy

  7. Knowledge Management

  8. Education & Training

  9. Other comments • Incorporation of relevant EC funded projects and networks; • IPR issues need to be addressed and clarified; define legal, ethical and other conditions for pre-competitive data-sharing. • Communication and PR should be a strategic tool in implementation • Pharmaceutical Engineering/manufacturing process of drugs; • Stronger Involvement of SMEs; • Personalised medicines/pharmacogenomics/genetic markers • More emphasis should be put on prevention • Integration of national networks and learned societies; • Infrastructures for different activities (clinical databases, monitoring facilities, etc.) of transversal nature allowing for extension to other disease areas • Timeframe seems too short to achieve goal of improving competitiveness of industry. • Clarify relation with EMEA roadmap. • Reinforce involvement of financial world

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