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 such as drug development and in particular clinical trial data.

To ensure effective compliance by 25th  May, 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).

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. In addition, 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.

Course Objectives:

• 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

Course Outline:

• 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

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

Anyone working in clinical trials including managers and quality assurance  personnel seeking to gain knowledge of the GDPR requirements applicable to clinical trials, or those who currently have a role in data protection or information security and need to understand how to comply with the regulation or clinical trials. Roles include:

• 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
• Pharmacovigilance for clinical trials
• Information security managers
• Data protection officers
• IT and corporate security managers involved in GXP areas of drug development
• Corporate governance managers responsible for clinical trials
• Risk and compliance managers responsible for clinical trials
• Internal legal teams with responsibility for clinical trials