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Drive your regulatory career
Courses at this level are for people at senior level taking on additional responsibilities or looking to diversify their skills.
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16/09/2025
Regulatory Requirements for Cell Tissue & Gene Therapies
Advanced therapy medicinal products (ATMPs), including cell, tissue, and gene therapies, present unique regulatory and scientific challenges. This course explores the complexities of ATMP development and examines the regulatory frameworks in the EU and UK, with comparisons to other major jurisdictions such as the US and Japan. Participants will consider classification, quality, clinical and non-clinical requirements, and the scientific principles that underpin these innovative therapies.
M220225F2F
16/09/2025
Regulatory Requirements for Cell Tissue & Gene Therapies
Advanced therapy medicinal products (ATMPs), including cell, tissue, and gene therapies, present unique regulatory and scientific challenges. This course explores the complexities of ATMP development and examines the regulatory frameworks in the EU and UK, with comparisons to other major jurisdictions such as the US and Japan. Participants will consider classification, quality, clinical and non-clinical requirements, and the scientific principles that underpin these innovative therapies.
M222025O
10/11/2025
Leadership and Strategic Management in Regulatory Affairs
This Masterclass is designed for regulatory affairs professionals to develop their understanding of the management and leadership skills needed to run a successful regulatory affairs department/organisation. The course is designed to be applicable to both drugs and device regulatory affairs by applying the principles taught to your own particular environment. This Masterclass is also Module 10 of the MSc.
MSCM1025
10/11/2025
Leadership and Strategic Management in Regulatory Affairs
This Masterclass is designed for regulatory affairs professionals to develop their understanding of the management and leadership skills needed to run a successful regulatory affairs department/organisation. The course is designed to be applicable to both drugs and device regulatory affairs by applying the principles taught to your own particular environment. This Masterclass is also Module 10 of the MSc.
MSCM1025O
18/11/2025
Data Management and Digitalisation in Regulatory Affairs
This Masterclass will provide you with the theoretical background to data management, document management, electronic submissions, eCompliance regulatory information management and the new identification of Medicinal Products (IDMP) requirements, and find solutions to practical problems in this area. Deal with large volumes of data and deal with different data (from nonclinical to post-market pharmacovigilance). This Masterclass is also Module 12 of the MSc.
MSCM12225O
18/11/2025
Data Management and Digitalisation in Regulatory Affairs
This Masterclass will provide you with the theoretical background to data management, document management, electronic submissions, eCompliance regulatory information management and the new identification of Medicinal Products (IDMP) requirements, and find solutions to practical problems in this area. Deal with large volumes of data and deal with different data (from nonclinical to post-market pharmacovigilance). This Masterclass is Module 12 of the MSc.
MSCM1225
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