Last month, BMI SYSTEM organized its first seminars in Barcelona and in Madrid, in order to raise awareness on transparency and data protection requirements in Spain.

Pharmaceutical & Medical Device companies are facing many compliance, regulatory & transparency changes with stringent requirements having to be met in short time-frames.
Moreover, the European Union has recently approved new and important reforms on data protection and in a few months’ time the first EFPIA disclosure report will be required.

More than 50 people attended the breakfast events in Madrid and in Barcelona. The attendees included compliance officers, data protection officers, medical directors and people from legal and marketing departments of pharmaceutical and medical device companies based in Spain, as well as from FARMAINDUSTRIA, the Spanish association of pharma companies in charge of Transparency regulation in the country.

This seminar was organized with Rousaud Costas Duran, a Spanish law firm which belongs to the 15 most important law firms in Spain and has a division dedicated to Life sciences.

The first goal of this seminar was to share our knowledge and experience regarding the impact of transparency regulation on the companies’ processes and organization, to answer the following questions, and to provide participants with pragmatic solutions:

  • What are the implications of data protection on transparency requirements?
  • What are the important changes compared to the previous regulations?
  • How to deal with cross border transfers of value?
  • How to handle consent?
  • How to comply with global requirements and enforce local ones?

The second goal was to share best practices for the first disclosure report that will take place this summer.

Miguel Geijo, Corporate & Compliance Partner Head of IT & Data Protection at Rousaud Costas Duran, presented the EU Data Protection Reform and the feedback on consent and claims management.

Laurent Clerc, Compliance & Transparency Expert at BMI SYSTEM, then explained how to manage transparency both at local and global levels.


Laurent CLERC during his presentation