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Le Palais des Congrès

2015年4月13日 (月) 午前 9:00 - 2015年4月13日 (月) 午後 12:30

2, Place de la porte Maillot, F-75017 Paris, France

EM04: PRIVACY AND PERSONAL DATA PROTECTION IN DRUG DEVELOPMENT

概要

This tutorial addresses issues in data privacy today:

  • Why is personal data protection important?
  • Principles of personal data protection, based on the European regulations
  • Overview of worldwide regulations and the differences between them
  • Specific regulations for biomedical research and pharmacovigilance impacting drug development
  • How to comply?
  • Information & consent
  • Communication & training
  • IT security & validation
  • Legal instruments (contracts, Safe Harbor, BCRs)
  • Data Privacy organisation

 

参加対象

This tutorial is designed for:

  • All individuals involved in the organisation and management of clinical trials and pharmacovigilance, or handling with data collected to perform these activities
  • Professionals working with health data, clinical data, genetic data, tissue samples, medical imaging, mobile health apps, and any kind of personal data in the field of drug development

 

 

学習目的

At the conclusion of this tutorial, attendees will be able to:

  • Understand the principles of personal data protection in the European Union 
  • Understand the differences between European, US and Asian data privacy regulations
  • Have a basic knowledge on how to comply with regulations in the specific field of drug development

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