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.
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 organisations that hold and process personal data particularly doe clinical trial data.
To ensure effective compliance by 25thMay, pharmaceutical and biotechnology organisations, 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 programme for running clinical trials. Organisations 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.
Areas Covered in the Session:
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
Considerations for governance to comply with the GDPR requirements
- Pharmaceutical Managers, Directors Working in GXP Areas
- Clinical Research Managers, VPs and Directors
- Quality Assurance for Clinical Trials /GXP
- Study Site Staff
- CROs and Other Vendors Working on Clinical Trials
- Data Management