Implementing GDPR in your Organisation – eLearning
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Date | Product | Location | Price | |
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Implementing GDPR in your Organisation | eLearning | EUR 625 | Book | |
If you would like to have this course as an in-house session click here |
About this course
Reasons to attend
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.What's included?
- 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 schedule
- Course credit: 6h (3 months period to complete course)
- Complete the course at anytime, anywhere!
Course Description
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.Programme highlight
- 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
Learning objectives
- 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
- Vendor selection teams
- SOPs writers
- Contract managers
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (2)
- Investigational Product Development and Regulation (1)
- Clinical Studies Operations (GCPs or ISO 14155) (0)
- Study and Site Management (1)
- Data Management and Informatics (0)
- Leadership and Professionalism (1)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
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