EU General Data Protection Regulation (GDPR): Compliance for Clinical Trials and Drug Development

Why Should You Attend:

With the new General Data Protection Regulation (GDPR) regulations coming in to effect in May 2018 there is a paradigm shift in the rules around usage and storing of personal data. Apart from EU companies the requirements apply to companies based outside of EU including US.

It is built around existing Data Protection legislation but with new rules there is a significant change in requirements on how to hold and process personal data particularly for clinical trial and drug development functions/organizations like Phrama, biotech, device and academic organization including vendors like CRO, CMO and study sites. They need to ensure management and staff understand the requirements of GDPR, should have a well-equipped and implemented data protection compliance program for running clinical trials and drug developments.

Attend this webinar to understand how the GDPR rules apply to clinical trials, the key areas, concepts, terms and definitions used in GDPR pertaining to clinical trials. Discussions will be on role of Data Protection Officer (DPO), how to identify potential impacts of privacy challenges for running clinical trials and ultimately how to put new governance and technical steps to comply with GDPR requirements.

Areas Covered in the Webinar:

• 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

Who Will Benefit:

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

Laura Brown
Independent QA and Training Consultant, Laura Brown Training and Development

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 and risk based monitoring. 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).

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