General Data Protection Regulation and Clinical Trials

Description
Regulatory

The GDPR (Regulation (EU) 2016/679) will have direct effect from May 25th, 2018 in all EU member states without any transitional period, replacing the EU Data Protection Directive.

The regulation emphasizes and standardizes transparency, security and the accountability of ‘Data Controllers’ with the aim to strengthen the rights of individuals.

Responsibilities and requirements of healthcare suppliers (including clinical researchers and companies) are clearly described.

This TRIUM session will start by offering you a high-level overview of the regulation, focusing on its definitions and requirements, immediately followed by explaining the impact on the conduct of clinical trials.

All your questions related to the data processes and protection principles in clinical trials, subject rights and consent and actions to be taken in case of a personal data breach will receive a clear and practical answer. It will enable you to conduct a data protection impact assessment for your organization’s current and future clinical trial needs, which will help you to set up an action plan to fill any data protection gaps by May 25th, 2018 and beyond.

Our aim is to ensure a lively, interactive, practical session with experts and peers that ensures you will be able to list your gaps and set-up your action plan for compliance immediately after.

At the end, you will receive a certificate and handy hand-outs for later use.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Describe the data protection requirements and obligations as per the GDPR (Regulation (EU) 2016/679)
  • List the responsibilities and obligations of healthcare professionals and companies, including clinical researchers
  • Conduct a data protection impact assessment and roll-out a related action plan for your organization to ensure timely compliance
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Trainer
Esther Daemen
Esther Daemen is currently ‘Quality &Training Director – Data Protection manager’ at TRIUM Clinical Consulting and has over 27 years of working experience in the healthcare/pharma & device field. She served many organizations in different research roles and as professional development director at ACRP global. She gained a bachelor’s in nursing and earned project management, training and DPO certificates as well as and a master´s degree in Business. Esther is also a highly sought-after presenter at professional conferences/universities and a writer of peer-reviewed articles for professional magazines like ‘The Clinical Researcher’. Her work was rewarded by the KP Morgan 'OECT Summit 10Years Speaker Achievement Award' in 2020, the ‘Best trainer to watch’ 2010 Training Magazine award and by having her organization ‘Kendle’ being listed as one of the top 125 training providers in the world in 2008. "TRIUM is an expert Contract Research Organization that offers a unique combination of global CRO services, staffing solutions, quality services, GDPR consultancy and risk-based approaches as well as training services. It’s our mission to be a passionate, dedicated business partner with a focus on excellence to provide start‐to‐finish clinical trial activities tailored to the timing, budget and specific needs of the Sponsor.”