Are you GDPR ready?
Since its beginning, the pharmaceutical industry has used and depended on personal data.
Under the new GDPR, this data is subject to higher standards of protection since much of the data utilised is considered ‘sensitive personal data’. The implementation of GDPR is intended to harmonise data privacy laws across Europe and provide greater data protection rights to the individual, which will introduce stricter provisions for the pharmaceutical industry; particularly in clinical trials and pharmacovigilance. GDPR brings with it serious implications for non-compliance and therefore, in such a heavily regulated industry, it is crucial to understand how to follow the correct methods of compliance. Attendees will have the opportunity to cement this knowledge through interactive case studies.
The course is complemented with a series of case studies related to data handling processes in line with GDPR compliance
Sumaiya Patel is a director of a regulatory consultancy with over 11 years’ experience in both pre and post-approvals for generic, CRO and big pharma organisations. Sumaiya has experience in regulatory implementation and training, focusing on CMC, clinical development, strategy and manufacturing. She has extensive experience in writing Module 3 of CTD, Module 2 of the CTD and also Quality Expert statements to support dossiers and Type II Quality variations. She has a track record of providing regulatory inputs related to CMC aspects during the development product lifecycle.
The course is relevant for anyone working in clinical research who could benefit from an in-depth understanding of the data protection laws and their implementation, those who are in a position with the responsibility of managing data within clinical or regulatory affairs, and those who are regulatory affairs professionals in the pharmaceutical industry.