Training: EU General Data Protection Regulation (EU GDPR)

Speaker Elena Lucano, PhD, Senior Manager, Quality and Regulatory Affairs

Date March 20th 2025, Online 

Duration 4 hours | 8:00 – 12:00 AM US Eastern Standard Time, 2:00 – 6:00 PM Central Europe Time 

Virtual A recording will be available to registered participants, in case they are not able to attend all the live sessions.

For more information or questions, please contact: training@veranex.com

About the Speaker Elena holds a PhD in Electronic Engineering from the University of Rome Sapienza. As a Senior Manager in Quality & Regulatory Affairs, she supports MedTech companies in submission and approval projects for the EU and US markets, with a special focus on Digital Health. In addition, as a certified DPO, she supports compliance with European Data Privacy Legislation. On the side, Elena manages Veranex’s training programs, including the CAS CARAQA program. 

TRAINING OBJECTIVES 

This training is organized with the goal of providing participants with an extended understanding of the requirements related to the General Data Protection Regulation (EU) 2016/679 (“GDPR”). The GDPR requirements will be presented in relation to other state legal frameworks. The training links key GDPR aspects with the MedTech word discussing handling of personal data and sensitive data as part of the everyday activities of a medical device manufacturer. The training will also cover the applicability of GDPR during Clinical Investigations and ISO 14155. 

TRAINING CONTENT  

Introduction 

  • From the data protection directive to the GDPR 
  • The need for data protection 
  • Data protection on different countries – some examples 
  • Relation between EU and US 
  • the GDPR, MDR/IVDR 

GDPR essential 

  • Regulation structure 
  • Main aspects and novelties 
  • Regulation applicability 

GDPR focus 

  • GDPR’s Rules on Processing Data 
  • Protection of Data, GDPR and ISO 27001, protection by design and by default 
  • GDPR’s Rules on Consent 
  • GDPR’s Rules on Processing Data  
  • Rights of the data subject 
  • GDPR Roles and Responsibilities (Supervisory authorities, Data controller and processor, DPO) 
  • GDPR’s Rules on data Breaches, and penalties  

TRAINING FORMAT  

  • Presentation with interactive discussions 
  • Exercises during the training 
  • End of training assessment  

TRAINING CERTIFICATE 

  • Participants will receive an EU GDPR training certificate upon successful completion of the end of training assessment. 

WHO SHOULD ATTEND 

Anyone directly or indirectly working for a company managing personal data either from direct collection by the Md/IVD device or through a clinical trial.  

PRICE  

EUR 415 incl. course material and certificate 

Register

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