Description

Regulatory Courses

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 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.

Course time
*Asynchronous part (eLearning, overall duration approx.6h): at your own pace; the course will remain available online for you for 3 months after you register for it *Synchronous part (live webinar where trainer interacts with audience): 1-hour public session, to be taken upon completion of the asynchronous part.
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
Programme highlights
  • 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
  • To understand the GDPR
  • To understand the reach of this regulation on your activities
  • To understand the reach of this regulation on the conduct of clinical trials
  • To know what roles you will need within your organisations
  • To be able to set up an action plan
  • To know when and how to organise a register
  • To know when and how to deploy a Data Protection Impact Assessment 
  • To know how to act in case of data breach

  

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)

Book a course

Date Lang Location
* Book now and learn at your own pace within the next 3 months
Proceeding your application may take up to 24 working hours. In case of question, contact campus@eccrt.com.
550,00 € excl. VAT (if applicable)