On the 25th of May 2018, the EU General Data Protection Regulation (GDPR) came into effect. But do you know what it means to your organisation and what impact 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 implementing GDPR course will help you to put in practice the GDPR in a CRO/pharmaceutical industry.
Documents and materials related to this course are included
Globally recognised certificates awarded after test completion
This course has been certified by TransCelerate and BioPharma
This course has been reviewed by the Belgian GCP Inspectorate.
Course credit: 6h (3 months period to complete course)
Complete the course at anytime, anywhere!
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 residents
EU companies, with EU activities.
Anyone working in Clinical Research who wishes to understand the Data Protection Laws and their implementation.
Higher management / Leadership team of a CRO / pharma industry, who are directly responsible for GDPR compliance
Members of the Quality Assurance / Quality Control department
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