Data Protection in Clinical Research and GDPR in action
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| 20/06/2023 | Data Protection in Clinical Research and GDPR in action | Brussels | EUR 1150.00 | Book |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
The purpose of this 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.Moreover, it will help you to put in practice the GDPR in a CRO/pharmaceutical industry. This training will allow you to make an action list of what is needed for your organization to be GDPR compliant. We will analyse the impact of the GDPR on different departments including clinical operations, vendor management, HR, …
What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course schedule
Course Description
The organisation of clinical trials might also include 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 and Belgian data protection rules.During the second part of the day, we will look at:
- GDPR in practice in clinical research
- Responsibilities of the
- Impact on your internal SOPs
- Action plan for various departments
- Reporting procedures in case of breach
Programme highlight
1st part of the day:
- Belgian and European data protection rules: definitions
- The applicable obligations when processing and transferring personal data
- How to apply the data protection rules in practice
- Impact (and action plan) on clinical trials and your organisation
- Impact on vendor management
- Is a DPO required or not and what should this person do?
Learning objectives
1st part of the day:
- Be able to identify the important data protection issues when organising clinical trials
- Become confident with the applicable Belgian and European data protection regulations
- Learn how to apply the data protection rules in practice
- Explain the reach of this regulation on the various departments of a CRO
- Learn the reach of this regulation on the Principal Investigator
- Be able to set up an action plan to be GDPR compliant
- Organise a register process to report a breach
- Deploy a Data Protection Impact Assessment (DPIA)
Who should attend
- Anyone working in Clinical Research who wishes to understand the Data Protection Laws and their implementation.
- Higher management of a CRO / the pharma industry
- Members of the Quality Assurance department
- Members of the Quality Control department
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 (2)
- Data Management and Informatics (1)
- Leadership and Professionalism (1)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
Ms. An Vijverman
Trainer
Panayota Boussis
Breast International Group
The content of the course was interesting and we discussed about practical cases. This is really helpful for my work.
Alicja Poczatenko
Medecines for Malaria Venture
I learned and understood the areas where my organization has to improve.
David Stanbury
Bionical Emas
Good organisation of the course: theory followed by practical implications.