ASSIGN ACADEMY

Data Protection in Clinical Trials

Compliance with data protection regulations is an essential aspect in the conduct of clinical trials. This half-day seminar will provide an overview of data protection regulation in the EU and Austria, with a particular emphasis on its application to clinical trials.

Data protection laws apply to the collection, processing and transfer of patient data in the course of a clinical trial. Compliance with these regulations is essential to the success of a clinical study, and it is important for all parties involved in clinical trials to be aware of their obligations.

  • This half-day seminar provides an overview of the data protection regulation in the EU and Austria, specifically the Data Protection Directive 95/46/EC and the Austrian Data Protection Act, with particular emphasis on the application of data security and privacy rules to clinical trials.
  • Apart from general data protection concepts and principles, the seminar addresses various specific issues important to the performance of clinical trials, such as registration and approval obligations, restrictions to data transfers within the EU and to third countries, and rights of data subjects.

The seminar is ideal for sponsors, project managers, investigators and other clinical trial professionals who would like to broaden their awareness of the ever more important implications of data protection on their work.

Speakers:


Dr. Hans Kristoferitsch, LL.M. (Harvard)


Hans Kristoferitsch is a partner at the Austrian law firm CHSH Cerha Hempel Spiegelfeld Hlawati. He brings broad experience in compliance and regulatory law and has specific expertise in a wide range of data protection matters including international data transfers, outsourcing and health data related issues relating, for example, to patient and clinical trial data. Mr. Kristoferitsch regularly represents clients before data protection authorities and provides training on data security and privacy.

 


Dr. Armin Schwabl, LL.M.


Armin Schwabl is an associate at CHSH Cerha Hempel Spiegelfeld Hlawati. He advises pharmaceutical, medical device, food and tobacco companies on a broad range of regulatory, compliance and transactional matters. His expertise includes clinical trial agreements, distribution and other marketing agreements. Mr. Schwabl writes and speaks regularly on various life sciences issues, such as pharmaceutical regulation.

Price: 75 €