The General Data Protection Regulation (GDPR) is new legislation that had come into force on 25th of May 2018 brings substantial changes to the rules around personal data and its use. While it aims at building 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.
To ensure effective compliance, 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 and drug development. 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.
Why should you 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.
Areas Covered in the Session
- Essential overview and background of the EU General Data Protection Regulation (GDPR)
- Understand how it applies 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
- 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
Who Will Benefit
- 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
Dr. Laura Brown , PhD, MBA, Diploma Clinical Sciences, is an independent QA and training consultant in the pharmaceutical industry. She is a managing director with LB Training and Development Ltd., course director for the M.Sc. in Clinical Research, School of Pharmacy at the University of Cardiff, and course director for M.Sc. Regulatory Affairs, TOPRA.
Dr. Brown has 20 years experience running clinical trials and clinical quality assurance in the pharmaceutical industry, and auditing clinical trials internationally. She has held a number of international and senior management QA positions in the pharmaceutical industry including her role as an associate director with a leading GCP audit consultancy.
She has worked for several international companies like GlaxoWellcome, Hoechst Marion Roussel and Phoenix International.
Dr. Brown has published material on the new EU Clinical Trial Regulation and also a practical guide to the current regulatory requirements for carrying out clinical trials in the EU. She has penned a chapter on training QA staff in the leading GXP book “Good Clinical, Laboratory and Manufacturing Practices” (2007).
She has authored SCRIP’s latest GCP guide and one entitled “Practical Guide to the Clinical Trial Directive”. She is also co-author of several books including “Developing the Individual” and “Project Management for the Pharmaceutical Industry”. She has regularly lectured at conferences and in training courses on QA and GXP issues.
Dr. Brown developed an e-learning module: “How to Prepare for Audit and Inspection” for Zenosis (a regulatory commercial e-learning training organization) in 2008 and is editor of an e-learning SOP series for Henry Stuart Conferences (2013).
She runs many training courses on topics such as: pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, GCP, regulatory requirements for clinical trials, the clinical trial directive, managing clinical trials, QA management and business skills, how to prepare for audit and inspection, how to audit, etc.