• Eight modules over one year: 8 modules over 1 year with an average of 24 hours of teaching per module
  • Schedule 8:00-12:00 /13:00-17:00 (indicative)
  • Teaching: 160 hours
  • Dissertation: 320 hours
  • Number of ECTS credits: 33
  • Each module is subjected to an evaluation in order to be accredited
  • Modules 2 to 10 may be attended individually
  • The DAS Management of Clinical Trials is embedded in the MAS Drug Discovery and Clinical Development, therefore Module numbering of the DAS Management of Clincial Trials is not continuous.

 

Module 2 | Principles and Methods of Clinical Research

September 25, 26, 27, 2017

Prof Thomas Perneger and Dr Angèle Gayet-Ageron

Module 2 | Principles and Methods of Clinical Research

September 25, 26, 27, 2017

Prof Thomas Perneger and Dr Angèle Gayet-Ageron

  • Development of research questions and choice of endpoints
  • Study designs
  • Statistical methods used in clinical research
  • Principles of Randomized Controlled Trials (RCT)
  • Critical review of publications
  • Development of study protocols
  • Choice of endpoints
  • Sample size calculation
  • Interim analysis planning

 

Module 3 | Ethical and Legal Aspect

October 13, 17, 18, 2017

Prof Samia Hurst, Prof Philippe Ducor and Dr Brigitte Happ

Module 3 | Ethical and Legal Aspect

October 13, 17, 18, 2017

Prof Samia Hurst, Prof Philippe Ducor and Dr Brigitte Happ

  • Clinical research ethics
  • Informed consent process
  • Data protection and confidentiality
  • Purpose and function of research Ethics Committees (EC)
  • Assessing risks and benefits to research participants
  • Vulnerable populations
  • Good Clinical Practices
  • Legal framework applicable in Switzerland, Europe and the United States for drugs, medical device and non-interventional trials
  • Clinical Trial Agreements and authorship issues
  • Ethical issues in biobanks

Module 4A | Preclinical Pharmacology, Toxicology and Clinical Pharmacology

November 13, 2017

Prof. Gerrit Borchard, Dr Youssef Daali, Dr Catherline Deloche and Dr Marie Besson

Module 4A | Preclinical Pharmacology, Toxicology and Clinical Pharmacology

November 13, 2017

Dr Youssef Daali, Prof Gerrit Borchard, Dr Catherline Deloche and Dr Marie Besson

  • Basics of pharmacology
  • Safety assessment in pre-clinical research
  • Investigational Medicinal Product Dossier (IMPD) and Investigator Brochure (IB)

 

Module 5 | Safety Management and Drug Development

December 11, 12, 2017

Dr Victoria Rollason, Dr François Curtin, Prof. Jules Desmeules

Module 5 | Safety Management and Drug Development

December 11, 12, 2017

Prof J Desmeules, Dr Victoria Rollason, and Prof Michel Lièvre

  • Risk management and safety monitoring during drug development
  • Safety assessment, documentation and reporting during clinical trials
  • Pre- and post-marketing pharmacovigilance
  • Role of Data and Safety Monitoring Boards (DSMB)

 

Module 7 | Clinical Trials Set-up and Conduct - Part 1

January 22, 23, 24, 2018

Dr Roch Ogier and Dr Manica Balasegaram

Module 7 | Clinical Trials Set-up and Conduct - Part 1

January 22, 23, 24, 2018

Dr Roch Ogier and Dr Manica Balasegaram

  • Scientific, strategic and safety considerations in clinical trial design
  • Budget development and resource planning
  • Investigator sites selection
  • Role of CROs and external providers
  • Clinical trial documents
  • Case Report Forms (CRFs) development
  • Standard Operation Procedures (SOP)
  • Submission to Ethics Committee (EC) and notification to Regulatory Authorities (RA)

 

Module 8 | Clinical Trials Set-up and Conduct - Part 2

February 19, 20, 21, 2018

Ms Virginie Vidal and Ms Jennifer Kealy

Module 8 | Clinical Trials Set-up and Conduct - Part 2

February 19, 20, 21, 2018

Ms Virginie Vidal and Ms Jennifer Kealy

  • Project management applied to clinical trials
  • Recruitment and retention of study subjects
  • Management of randomization and blinding systems
  • Data collection and data management
  • Management of investigational medicinal product
  • Documents and records
  • Monitoring of clinical studies
  • Root-cause analysis

 

Module 10 | Clinical Trials Close-out and Reporting

March 19, 20, 2018

Dr Roch Ogier and Dr Mariagrazia Di Marco

Module 10 | Clinical Trials Close-out and Reporting

March, 19, 20, 2018

Dr Roch Ogier and Dr Mariagrazia Di Marco

  • Study close-out activities
  • Data cleaning and database lock
  • Preparation of Statistical Analysis Plan (SAP)
  • Results review and interpretation
  • Dissemination and publications of study results
  • Clinical Trials reporting
  • Dossier preparation and submission for Marketing Authorization Applications (MAA)
  • Regulatory specificities of medical devices, orphan drugs and pediatric drugs

 

Module 11 | Audits and Inspections

May 2, 3, 4, 2018

Dr Isabelle Mercier and Dr Jocelyne Chabert

Module 11 | Audits and Inspections

May 2, 3, 4, 2018

Dr Isabelle Mercierl and Dr Jocelyne Chabert

  • Quality management systems
  • Purpose and conduct of regulatory inspections
  • Audit
  • Site preparation to inspections