Clinical trial participants privacy and confidentiality of their medical records has been well protected since long-time and described guidances and regulations such as ICH GCP and country specific regulations. However the global landscape on how personal data are collected and protected continues to evolve.
120.00€
Since 25 May 2018 and entry of General Data Protection Regulation in force in the European Union, clinical trial sponsors have to make sure that they apply those principles when conducting clinical trials. Other countries and regions have since implemented privacy legislation and navigating through those becomes a challenge for the sponsor of a global clinical trial.
We created this course to help you understand the current data protection environment globally, give you an understanding of the principles that govern them on the example of the EU GDPR and provide practical examples on how to implement those principles for clinical trials.
4 sections, all of them containing interactive exercises and quizzes to reinforce acquisition of the key take-home messages :
1. Data privacy history, global landscape and regulatory background. General Data Protection Regulation (GDPR) 2016/679 overview
2. GDPR principles.
3. Personal data and their management in compliance with GDPR.
4. Key GDPR actors (controller, processor, data subject) – their rights and obligations including data subject rights, data breach reporting, interplay between GDPR required information and clinical trial informed consent.
Maria Sliwowska,
ObelysQ SA Switzerland
Maria is a physician by education, holds a degree in epidemiology, and is currently certified as Information Privacy Professional/Europe (CIPP/E). For the past 20 years, she has worked in various Quality Assurance roles across GCP, GCLP, GVP, CSV and data privacy and advanced analytics space.
Maria had the opportunity to support various Health Authority inspections, perform audits globally and manage auditing training. More recently Maria has been involed in helping translate the interactions of the clinical trial and data privacy regulations into pragmatic and compliant privacy programs.
Maria has worked the past for Biotech companies, big pharmas, clinical research organizations, and non-governmental organizations. The quality journey took Maria from Poland, through Germany and the UK to Switzerland.
| Objectives | The objectives of this course are to provide an overview of data protection landscape globally and its implications for clinical research. |
|---|---|
| Duration of the of the course | 60 minutes |
| Language | English |
| Certification | A certificate of completion will be delivered at the end of the training. |
| Targeted audience | Clinical research professionals involved in the conduct of clinical trials in EU: Pharma sponsors, CROs, academic sponsors, hospital clinical research units. From operational to management levels whether the organization is located in the EU or not. |
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