• Twelve modules over one year
  • Teaching: 280 hours
  • Dissertation: 540 hours
  • Number of ECTS credits: 60
  • Each module is subjected to an evaluation in order to be accredited. 

Module 1 | Introduction to Clinical Development: Challenges and Prospects

August 24, 25 and 26, 2016

Dr Emilie Alirol and Dr François Curtin

Module 1 | Introduction to Clinical Development: Challenges and Prospects

August 24, 25 and 26, 2016

Dr Emilie Alirol and Dr François Curtin

  • Definition of pharmaceutical development: purpose, players and phases
  • Success and failure in drug discovery and development
  • Fundamentals of health economics
  • Intellectual property
  • Marketing strategies in drug development
  • Alternative models of drug development: Product Development Partnerships and Not-for-Profit entities

Module 2 | Preclinical Pharmacology, Toxicology and Clinical Pharmacology

September 14,15 and 16, 2016

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

Module 2 | Preclinical Pharmacology, Toxicology and Clinical Pharmacology

September 14,15 and 16, 2016

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

  • Fundamentals of pharmacology
  • Safety assessment in pre-clinical research
  • Investigational Medicinal Product Dossier (IMPD) and
  • Investigator Brochure (IB)
  • Toxicology requirements
  • Basic of clinical pharmacology
  • Pharmacokinetics / Pharmacodynamics modelling
  • Drug metabolism

Module 3 | Safety Management and Drug Development

September 19 and 20, 2016

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

Module 3 | Safety Management and Drug Development

September 19 and 20, 2016

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 4 | Principles and Methods of Clinical Research

October 3, 4, and 5, 2016

Prof Thomas Perneger and Dr Angèle Gayet-Ageron

Module 4 | Principles and Methods of Clinical Research

October 3, 4, and 5, 2016

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 5 | Medical Statistics and Trial Methodologies

November 7, 8, 9 and 10, 2016

Dr François Curtin and Dr David W Warne

Module 5 | Medical Statistics and Trial Methodologies

November 7, 8, 9 and 10, 2016

Dr François Curtin and Dr David W Warne

  • Statistical principles for drug development: ICH E9
  • Distributions
  • Parameters estimators
  • Power calculations
  • Clinical trials designs: parallel, cross-over, sequential, and adaptive designs
  • Pharmaco-epidemiology

Module 6 | Ethical and Legal Aspect

December, 5, 6 and 7, 2016

Prof Samia Hurst, Prof Philippe Ducor and Dr Brigitte Happ

Module 6 | Ethical and Legal Aspect

December, 5, 6 and 7, 2016

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 7 | Planning of Clinical Trials

January 11, 12 and 13, 2017

Dr Roch Ogier and Dr Manica Balasegaram

Module 7 | Planning of Clinical Trials

January 11, 12 and 13, 2017

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 | Conduct and Management of Clinical Trials

February 6, 7 and 8, 2017

Ms Virginie Vidal and Ms Jennifer Kealy

Module 8 | Conduct and Management of Clinical Trials

February 6, 7 and 8, 2017

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 9 | Regulatory Consideration in Drug Development

March 8, 9 and 10, 2017

Dr Brigitte Happ and Ms Marion Laumonier

Module 9 | Regulatory Consideration in Drug Development

March 8, 9 and 10, 2017

Dr Brigitte Happ and Ms Marion Laumonier

  • Role and responsibilities of regulatory agencies
  • International regulatory environment
  • EU and US legislation
  • Early access to new therapeutic products
  • Life-cycle management
  • Special populations
  • Medical devices
  • Regulatory strategies and health agencies interactions

Module 10 | Close-out and Reporting of Clinical Trials

April 5 and 6, 2017

Dr Roch Ogier and Dr Mariagrazia Di Marco

Module 10 | Close-out and Reporting of Clinical Trials

April 5 and 6, 2017

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)

Module 11 | Audits and Inspections

May 22, 23 and 24, 2017

Dr Emilie Alirol and Dr Jocelyne Chabert

Module 11 | Audits and Inspections

May 22, 23 and 24, 2017

Dr Emilie Alirol and Dr Jocelyne Chabert

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

Module 12 | New Perspectives, Personalized Medicine and New Therapeutics

June 19, 20 and 21, 2017

Dr Caroline Samer and Dr Patricia Delaite

Module 12 | New Perspectives, Personalized Medicine and New Therapeutics

June 19, 20 and 21, 2017

Dr Caroline Samer and Dr Patricia Delaite

  • Biomarkers
  • Personalized medicines
  • Drug development of biologicals
  • Generics and biosimilars