PCMG Interactive Workshop
April 2nd 2019, Crowne Plaza Hotel Copenhagen

How has our industry implemented GDPR?

What is current best practice and how can Outsourcing Management maintain compliance?

What challenges lie ahead?

The introduction of the General Data Protection Regulation (GDPR) on 25th May 2018 significantly changed how personal data should be processed.  Compliance within the pharmaceutical has been more straight forward than in many other industries, in part because of an existing and deep-rooted respect for sensitive, personal medical information and the absolute requirement for subject confidentiality.  Nevertheless a great deal of additional work has been required within the industry to ensure compliance with the new regulations, including process analyses, changes in internal policies and contract renegotiation and alignment with third parties. One year on, we will take a look back on our learnings; how has the industry implemented GDPR? What is current best practice for GDPR compliance?  And what challenges still lie ahead?

This workshop addressed lessons learned through the implementation of GDPR in Drug Development. We discussed different perspectives on the realities of GDPR compliance, as follows:

  • Examine GDPR implementation from the viewpoint of the sponsor, the CRO, the EFPIA/EMA and Investigational sites in clinical research;
  • Define and share best practice with regards to the contracting processes, handling different types of personal data in different areas of drug development and practical implications in outsourcing;
  • Assess the risks and practical obstacles on the path of implementing GDPR

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