Attain an understanding of the General Data Protection Regulation (GDPR). Be able to understand the key of the main tenets of GDPR which impact on clinical trials. Consider data breaches. Understand the role of the Data Protection Officer (DPO).
Ascertain how the new rules around GDPR apply to your organization. Have greater ability to identify potential impacts of privacy challenges for running clinical trials. Review the new governance and technical steps in your organization to comply with the GDPR requirements.
Learning Objectives:
- Essential overview and background of the EU General Data Protection Regulation (GDPR)
- Understand how it will apply to clinical trials and the pharma industry
- Special Categories of Personal Data includes clinical trial data
- The Rights Of clinical trial Subjects, Including Data Access Requests, informed consent
- Controllers & Processors
- Reporting Data Breaches
- The Role Of The Data Protection Officer (DPO)
- Transferring clinical trial Data Outside The EU
- Penalties
- Considerations for governance to comply with the GDPR requirements
Why Should You Attend:
The General Data Protection Regulation (GDPR) is new legislation that comes into force on 25th of May 2018 which brings substantial changes to the rules around personal data and its use. While it builds on existing Data Protection legislation, it represents a significant change for organizations that hold and process personal data particularly doe clinical trial data.
To ensure effective compliance by 25thMay, pharmaceutical and biotechnology organizations, vendors including CRO, and study sites need to ensure management and staff understand the requirements of the GDPR and are well equipped to plan, implement and maintain a data protection compliance program for running clinical trials. Organizations collecting clinical trial data will also need to appoint a suitably qualified and trained data protection officer (DPO).
This webinar on the GDPR will help you understand how it will apply to clinical trials.
By attending this webinar you will be better prepared to comply with the new regulation, as well as understand the key areas, concepts, principles, terms and definitions used in the GDPR relevant to clinical trials. The session will help you develop your awareness of non-compliance with the new GCPR regulation fines: 4% of global annual turnover or €20 million.
Instructor Profile:
Dr. Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance and regulatory requirements in clinical trials in the pharmaceutical industry.
She has worked in senior positions for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including data protection and data integrity in clinical trials. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues in clinical trials.