Preconference Short Courses

Short Courses require separate registration. Please click the "Learn More" button under each course to see more details and to register.

• Workshop: Revision of the EU Clinical Trial Risk Mitigation Guideline
• Hot Topics in Pharmacovigilance
• Moving from Risk Management to Benefit-Risk Management
• The Science of Lay Language Communication Applied in a Pharmaceutical Context
• Genomics in Clinical Development
• Current Medical Device Market Surveillance and Vigilance Reporting Requirements in Europe - Concept and Best Practices
• Guidance for Patient Involvement in Pharmaceutical Industry-Led Research

• Workshop: Revision of the EU Clinical Trial Risk Mitigation Guideline

  Monday, 16 April, 14:00 - 17:30

  Jan Willem Van der Laan
  Section on Pharmacology, Toxicology and Kinetics (FTK), Medicines Evaluation Board (MEB), Netherlands

  David Jones
  Expert Pharmacotoxicologist, Clinical Trials Unit, Medicines and Healthcare products Regulatory Agency (MHRA), UK

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• Hot Topics in Pharmacovigilance

  Monday, 16 April, 14:00 - 17:30

  Anja Van Haren
  EudraVigilance Coordinator, Medicines Evaluation Board (MEB), Netherlands

  EMA Instructor Invited

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• Moving from Risk Management to Benefit-Risk Management – Embedding Pharmacovigilance Principles into the Product Life Cycle

  Monday, 16 April, 14:00 - 17:30

  Shelley Gandhi
  Director Pharmacovigilance and Drug Safety, NDA Group, UK

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• The Science of Lay Language Communication Applied in a Pharmaceutical Context: Readability and Understanding of Documents

  Tuesday, 17 April, 09:00 - 12:30

  Thomas M. Schindler
  Head Medical Writing Europe, Boehringer-Ingelheim Pharma GmbH, Germany

  Claudia Thoms
  Institute of Communication Science and Theory of Communication, University of Hohenheim, Germany

  Oliver Haug
  Managing Director, H&H Communication Lab GmbH – The Readability Resource, Germany

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• Genomics in Clinical Development

  Monday, 16 April, 14:00 - 17:30

  Thomas Szucs
  ECPM, University of Basel and Helsana Health Insurance, Switzerland

  Urs Meyer
  Biocenter, University of Basel, Switzerland

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• Current Medical Device Market Surveillance and Vigilance Reporting Requirements in Europe - Concept and Best Practices

  Tuesday, 17 April, 09:00 - 12:30

  Course details to be confirmed.

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• Guidance for Patient Involvement in Pharmaceutical Industry-Led Research

  Monday, 16 April, 14:00 - 17:30

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