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EU General Data Protection Regulation (GDPR): Compliance for Clinical Trials and Drug development
- 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
Overview of the webinar
The requirements apply to companies based outside of the EU, including the US.The General Data Protection Regulation (GDPR) is new legislation that come 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 for clinical trial data and drug development. Pharmaceutical, biotechnology, device and academic organisations, vendors including CRO, CMO and study sites need to ensure management and staff understand the requirements of the GDPR and are well equipped have implemented and maintain a data protection compliance programme for running clinical trials and drug development. 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.
Who should attend?
Anyone working in drug/device development 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 for clinical trials.
Roles include:
- Pharmaceutical/Biopharmaceutical/device 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
Why should you attend?
- 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
Faculty - Dr.Laura Brown
Dr. Laura Brown is an independent Pharmaceutical QA, Management and Training Consultant and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 20 years' experience of Quality Assurance and managing international clinical trials including risk identification and management. She has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has consulted with numerous pharmaceutical companies, suppliers to the pharmaceutical industry as well as academic institutions.
Dr. Brown has an MBA with specialization in project management including risk management. She is also the external project management expert for a pharmaceutical e-learning MSc module in project management covering risk management and the author of two books on project management including the leading book “Pharmaceutical Project Management” (Gower).