Introduction to I.D.E.A., Ltd
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Introduction to I.D.E.A., Ltd

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I.D.E.A. Ltd. supplies Legal Representative Services to sponsors of clinical trials and orphan drug designations (ODDs) who do not have business premises in the EU.

I.D.E.A. Ltd. supplies Legal Representative Services to sponsors of clinical trials and orphan drug designations (ODDs) who do not have business premises in the EU.

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Introduction to I.D.E.A., Ltd Introduction to I.D.E.A., Ltd Presentation Transcript

  • Providing Legal Representation for Clinical Trials in the EU
  • Overview • I.D.E.A., Ltd. is a privately-held professional services company that fulfils the requirement for Legal Representation specified in Article 19 of the Clinical Trials Directive − Compliance required by Directive 2001/20/EC, Art.19, for non-EU Sponsors
  • History of I.D.E.A. • Founded in 2006 − Satellite of HCR, a full-service, global CRO • Specialist Legal Representative service for non-EU clinical trial sponsors • Hold Orphan Drug Designations (ODD’s) for non-EU companies
  • History of I.D.E.A. • Preferred provider for small/medium CRO’s − Stabilized pricing, accurate budgeting − Continuity across multiple programs/projects • Strong repeat business − Excellent reputation supports word of mouth referrals • Fully independent − Neutral
  • Why Conduct Ph I-IV Clinical Trials in the EU? • 28 member states in the EU − Number of member states will increase • Population = 510 million − Ethnically diverse − Demographic distribution similar to US • Robust healthcare infrastructure − Study-naïve, compliant patient population
  • Summary of Requirements • Trial can not be approved by Regulatory or Ethics authorities without EU Legal Representative • Compliance required by Directive 2001/20/EC, Art.19, for non-EU Sponsors − Takes on the position of the Sponsor in the EU to ensure compliance to regulations and GxP − Point-of-contact for EU authorities − Applicable in all EU member states
  • Summary of Requirements • Must understand EU clinical trial legislation and the regulatory environment • May have different legal representatives for each trial or one for all EU trials • A Sponsor who wants to conduct an EU clinical trial but does not have an EU office...  Must have an EU Legal Representative
  • Management Team Dr Francisco Harrison, Chairman, Germany ▫ Over 30 years experience in management and operation of clinical trials including as Chief Investigator for multi-centre trials ▫ Founder & Board level management of several diverse companies ▫ Founded Harrison Clinical Research in 1987 (now VP for SynteractHCR) Tamsyn Frost, Director, UK ▫ Over 6 years experience in Regulatory Affairs - specialising in Quality/Regulatory interface, Clinical Trials and Orphan Drug Development ▫ Experience in quality management, project coordination and business development. Background in applied biology and reproductive toxicology ▫ Currently completing the TOPRA MSc in Regulatory Affairs
  • IDEA Ltd: Contact Information Ta m s y n F r o s t Director tamsyn.frost@eurepresentative.com 4th Floor, 1 Kingdom St. Paddington London W2 6BD United Kingdom www.eurepresentative.com Francisco Harrison Chairman f.harrison@eurepresentative.com info@eurepresentative.com Tel: +44 (0)1223 402 666 Fax: +44 (0)1223 413 689