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IMI Comments on SRA (version July 2005)

IMI Comments on SRA (version July 2005). MSCG meeting 20 March 2006 Bernd Rainer. Concerted Feedback/Input on SRA received from:. Austria, Denmark, France, Germany, Hungary, Ireland, The Netherlands, Poland, Sweden, UK, Romania, Turkey, Norway. Additional input on SRA from:.

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IMI Comments on SRA (version July 2005)

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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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