1. Center for Clinical Research - Clinical Trials Center (CTC) 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

2. 1 Center for Clinical Research - Clinical Trials Center (CTC) Overview  Clinical Research in Switzerland  IITs – SCTO – CTUs  Regulatory Background – Switzerland and Europe

3. 2 Center for Clinical Research - Clinical Trials Center (CTC) 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. 3 Center for Clinical Research - Clinical Trials Center (CTC) Clinical Research in Switzerland  Investment in switzerland

5. 4 Center for Clinical Research - Clinical Trials Center (CTC) Clinical Research in Switzerland

6. 5 Center for Clinical Research - Clinical Trials Center (CTC) 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. 6 Center for Clinical Research - Clinical Trials Center (CTC) 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. 7 Center for Clinical Research - Clinical Trials Center (CTC)

9. 8 Center for Clinical Research - Clinical Trials Center (CTC) 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

10. 9 Center for Clinical Research - Clinical Trials Center (CTC) 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)

11. 10 Center for Clinical Research - Clinical Trials Center (CTC) Regulatory Background – Europe Directive 2001/20/EC (GCP directive) Directive 2005/28/EC Directive 2001/20/EC (GCP directive) Directive 2005/28/EC Regulations in EU countries (Laws, ordinances) Regulations in EU countries (Laws, ordinances) 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) 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)

12. 11 Center for Clinical Research - Clinical Trials Center (CTC) 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

13. 12 Center for Clinical Research - Clinical Trials Center (CTC) 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

14. 13 Center for Clinical Research - Clinical Trials Center (CTC) Research with human beings Clinical TrialIMP Category A, B or C Medical Device Category A or C Transplantation Category A or C Health Intervention Category A or B Non-Clinical Trial Risks = minimalRisks > minimal Regulatory Background – Europe, Switzerland Risk Categorisation In Switzerland

15. 14 Center for Clinical Research - Clinical Trials Center (CTC) 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

16. 15 Center for Clinical Research - Clinical Trials Center (CTC) Thank you for your attention