GFPR Compliance for Drug Development
Dr. Laura Brown, Ph.D., MBA, Diploma Clinical Sciences, is an independent QA and Training Consultant in the Pharmaceutical Industry as Managing Director LB Training and Development Ltd., Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff, and Course Director MSC Regulatory Affairs, TOPRA.
Laura has more than 20 years’ experience of drug development and quality assurance in the pharmaceutical industry, including writing SOPs and auditing internationally and helping to prepare companies for inspection.
Laura Brown has held a number of international and senior management QA positions in the pharmaceutical industry including as an Associate Director with a leading GXP audit consultancy preparing and managing SOPs. She has worked for several international companies including Glaxo Wellcome, Hoechst Marion Roussel, and Phoenix International.
Laura is the author of a chapter on “Training QA staff” in the leading GXP book: “Good Clinical, Laboratory and Manufacturing Practices”. 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 on training courses on SOPs and quality issues.
Laura developed an e-learning module: “How to Prepare for Audit and Inspection” for Zenosis (A regulatory commercial e-learning training organization and is editor of an e-learning SOP series.
Laura runs many training courses both on public courses and in-company on topics including pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, 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.
The General Data Protection Regulation (GDPR) came into force on 25 May 2018 and brought substantial changes to the rules around personal data and its use. Most companies have implemented requirements such as creating records for personal data processing activities, preparing data protection assessments. However, while the GDPR built on the previous data protection legislation, it represented a significant change for organizations that hold and process personal data including clinical trial data. Also, the requirements apply to companies based within and outside of the EU, including the US.
To ensure effective compliance, pharmaceutical, biotechnology, and device organizations, universities, and hospitals involved in clinical trials and vendors (including CROs) need to ensure management and staff understand the GDPR requirements and have implemented and maintained a data protection compliance programme for running clinical trials. Organizations collecting clinical trial data should also have appointed a suitably qualified and trained data protection officer (DPO).
This webinar on the GDPR will help you understand what you should have put in place to comply for clinical trials GDPR requirements with a 1-hour presentation, followed by a discussion session.
By attending this webinar you will be able to check compliance with the new regulation, as well as ensure you understand the key areas, concepts, principles, terms, and definitions used in the GDPR relevant to drug development and in particular clinical trials.
The session will your awareness of non-compliance with the new GCPR regulation - remember potential fines: 4% of global annual turnover or €20 million.
- Ensure your understanding of the General Data Protection Regulation (GDPR)
- Review implementation of the main principles of GDPR which impact on clinical trials
- Consider data breaches and how to avoid these
- Understand the role of the Data Protection Officer (DPO)
- Ascertain how the new rules around GDPR should have been implemented 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 help compliance with the GDPR requirements
- 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’ and clinical trial data
- The rights of clinical trial subjects, Including data access requests, informed consent
- Controllers & processors
- Reporting data breaches
- Data Protection Risk Assessment
- The role of the Data Protection Officer (DPO)
- Transferring clinical trial data outside the EU in compliance with the GCPR
- Considerations for governance to comply with the GDPR requirements
Course Level - Basic and Intermediate
Who Should Attend
Anyone working in drug development and particularly clinical trials, including managers and quality assurance personnel, DPOs, seeking to ensure compliance with the GDPR requirements applicable to clinical trials. It is also applicable to anyone have a role in data protection or information security and need to comply with the regulation within a clinical trial context.
- 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
- Pharmacovigilance for clinical trials
- Data protection officers (DPOs)
- 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