the 25th of May 2018, the EU General Data Protection Regulation (GDPR) came
do you know what it means to your organisation and what the impact of it is on
your day-to-day activities? The
GDPR does not only apply to EU organisations, but to all organisations
worldwide, from the moment they have sensitive data from an EU citizen. Per
definition, the impact on the pharma industry is huge since it uses personal
data on a regular basis.This eLearning course
will help you to put in practice the GDPR in a CRO/pharmaceutical industry.
This eLearning course will explain how the GDPR affects your organisation, with focus on clinical operations but also for your business development activities, contracts with sites & vendors, etc…
Indeed, the organisation of clinical trials might also result in important data protection issues. It is important to know under what conditions the personal data of the patients participating in clinical trials (and of the investigators) can be processed in accordance with the applicable European data protection rules. The purpose of the course is to explain how and under what conditions you can gather, collect, process, transfer (inside or outside the European Union), anonymise or encode and delete personal data as part of clinical trials.
Once you completed the eLearning course, you will be offered to attend a live 1-hour webinar (1 session organised/quarter) with your trainer, Ms. Nancy Cottigny. Do not miss this opportunity to get all your questions answered by our subject matter expert.
European data protection Regulation
The applicable obligations when processing and transferring personal data
How to apply the data protection regulation in practice
Impact (and action plan) on clinical trials and your organisation
Impact on vendor management
Is a Data Protection Officer required or not and what should this person do?
Responsibilities of the CRO / Sponsor / Hospital
Impact on your internal SOPs
Action plan for various departments: Contract management / Clinical operations / Quality
Reporting procedures in case of breach
Understand the GDPR
Comprehend the reach of this regulation on your activities
Explain the reach of this regulation on the conduct of clinical trials
Know what roles you will need within your organisations
Be able to set up an action plan
Describe when and how to organise a register
Explain when and how to deploy a Data Protection Impact Assessment
Know how to act in case of data breach
Who should attend
non-EU companies collecting personal Data of
EU companies, with EU activities.
working in Clinical Research who wishes to understand the Data Protection Laws
and their implementation.
management / Leadership team of a CRO / pharma industry, who are directly
responsible for GDPR compliance
of the Quality Assurance / Quality Control department
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.