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Clinical Research and Clinical Trials in Switzerland

Clinical Research and Clinical Trials in Switzerland. Jürg Lustenberger, PhD Dipl . Pharm. Med. SwAPP , MRQA Head QM, CTC, University Hospital and University Zurich; CEO & GCP/GMP Auditor and Consultant, SwissPharmAudit. Overview. Clinical Research in Switzerland IITs – SCTO – CTUs

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Clinical Research and Clinical Trials in Switzerland

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  1. Clinical Research and Clinical Trials in Switzerland Jürg Lustenberger, PhDDipl. Pharm. Med. SwAPP, MRQA Head QM, CTC, University Hospital and University Zurich; CEO & GCP/GMP Auditor and Consultant, SwissPharmAudit

  2. Overview Clinical Research in Switzerland IITs – SCTO – CTUs Regulatory Background – Switzerland and Europe

  3. Clinical Research in Switzerland Regulated by laws and ordinances (medicinal products and medical devices) Industry sponsored trials and Investigator Initiated Trials (IITs) regulated in the same way Swissmedic, BAG = Regulatory Authorities 236 trials submitted to Swissmedic in 2011 17 inspections in 2011, 6 of them at Clinical Trial Units at Universities in Switzerland

  4. Clinical Research in Switzerland Investment in switzerland

  5. Clinical Research in Switzerland

  6. Clinical Research in Switzerland Pharma Industry does support IITs Public institutions and programmes are supporting IITs: Bilateral Science and Technology Cooperation Programmes Research credits/grants of Universities Swiss National Science Foundation (SNSF) The Human Frontier Science Program HFSP European Research Council CTI – the commission for technology and innovation etc.

  7. Objectives of IITs Optimising existing medicinal products, therapies, diagnostic techniques and surgical procedures Evaluation of treatment strategies for orphan diseases Exploring efficacy of marketed drugs in new indications, populations and/or conditions Answers to questions from clinical practice

  8. Clinical Trials Units (CTUs) Support primarily „Investigator Initiated Trials“ (IITs) Consult clinics, institutes and hospitals in regard to clinical trials Support research in international networks Set up and maintenance of quality management system Implementation of web-based data management system Responsible for education in clinical research

  9. Regulatory Background – Switzerland Clinical trial: Any trial carried out on human subject with the intention of systematically verifying the safety, efficacy or other properties of a therapeutic product or its bioavailability. Federal Act on Medicinal Products and Medical Devices(Therapeutic Products Act, TPA of December 2000) Ordinance on clinical trials of therapeutic products (VKlin / Oclin of October 2001) Ordinance on medical devices (MepV of October 2001)

  10. Regulatory Background – Europe Directive 2001/20/EC (GCP directive) Directive 2005/28/EC 90/385/EEG (AIMD) 93/42/EEG (MD) 98/79/EG (IVD) 2007/47/EG (amending 93/42/EEG, 90/385/EEG) Guidelines (MEDDEVs, ISO 14155:2011) Regulations in EU countries (Laws, ordinances) Regulations in EU countries (Laws, ordinances)

  11. Regulatory Background – Europe, Switzerland Outlook New drafts of or updated regulations available since 2012 Generally, change towards risk adapted evaluation of clinical trials, harmonised procedures with less administrative and cost burdens, use of public registers Europe: Directive 2001/20/EC planned to be updated until 2016 (including change into regulation) Switzerland: new regulation «Humanforschungsgesetz» (Human Research Act) in force beginning of 2014

  12. Regulatory Background – Europe, Switzerland Outlook Switzerland: first drafts of ordinances were released by BAG beginning of September Ordinance on clinical trials (HFV1) Ordinance on non-clinical trials (HFV2) Ordinance on organisation (OV-HFG) Review process by interested parties with comments back to BAG until end of October 2012 Switzerland ahead of Europe which can be an advantage in regards to clinical trials

  13. Regulatory Background – Europe, Switzerland Risk Categorisation In Switzerland

  14. Regulatory Background – Europe, Switzerland Consequences in Switzerland Compatibility with international requirements Registration of the trials in public registers Faster evaluations of clinical trials adapted to their risks Quality management measures adapted to the assessed risk should be implemented Better regulation of research with biological material and health data In general, clinical research will benefit

  15. Thank you for your attention

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