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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.
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: