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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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01/07/2025
Regulatory Requirements for Cell Tissue & Gene Therapies
Module 22 of the MSc and Masterclass: Designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of advanced therapy medicinal products, which has grown in significance over the past five years. It fills a gap in the educational needs for contemporary regulatory affairs specialists. It will allow students to examine the regulatory requirements for advanced therapy medicinal products in the EU and compare this with other territories. It will consider the scientific principles underpinning the development and regulation of advanced therapy medicinal products and the complexities involved.
M220225F2F
01/07/2025
Regulatory Requirements for Cell Tissue & Gene Therapies
Module 22 of the MSc and Masterclass: Designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of advanced therapy medicinal products, which has grown in significance over the past five years. It fills a gap in the educational needs for contemporary regulatory affairs specialists. It will allow students to examine the regulatory requirements for advanced therapy medicinal products in the EU and compare this with other territories. It will consider the scientific principles underpinning the development and regulation of advanced therapy medicinal products and the complexities involved.
M222025O
12/05/2025
The EU Paediatrics Regulation
This Masterclass will help you to gain an understanding of . This Masterclass is also Module 23 of the MSc.
M230525F2F
12/05/2025
The EU Paediatric Regulation
This Masterclass will help you to gain an understanding of This Masterclass is also Module 23 of the MSc.
M230525O
30/07/2025
Regulatory Environment in the Middle East and North Africa
This Masterclass will help you to gain an understanding of . This Masterclass is also Module 24 of the MSc.
M240725F2F
30/07/2025
Regulatory Environment in the Middle East and North Africa
This Masterclass will help you to gain an understanding of . This Masterclass is also Module 24 of the MSc.
M24300725O
30/09/2025
The Regulatory Environment in South/East Asia
This Masterclass will help you to gain an understanding of This Masterclass is also Module 25 of the MSc.
M2525F2F
30/09/2025
The Regulatory Environment in South/East Asia
This Masterclass will help you to gain an understanding of . This Masterclass is also Module 25 of the MSc.
M2525O
11/02/2025
Regulatory Strategy for a New Active Substance Non-clinical
This Masterclass will give delegates an understanding of the practical and legislative requirements for the non-clinical phase of global drug development. It will explore the regulatory issues that are likely to arise and provide advice and discussion around solutions to such situations. This Masterclass is also Module 2 of the MSc.
MC22025F
11/02/2025
Regulatory Strategy for a New Active Substance Non-clinical
This Masterclass will give delegates an understanding of the practical and legislative requirements for the non-clinical phase of global drug development. It will explore the regulatory issues that are likely to arise and provide advice and discussion around solutions to such situations. This Masterclass is also Module 2 of the MSc.
MC22025O
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
01/04/2025
Regulatory Strategy for Established Active Substances
This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of and the strategic issues to be considered in relation to medicines containing established active substances, including line extensions, generics and the relevant aspects for over-the-counter (OTC) products. It will allow them to examine the regulatory requirements imposed on these substances. This Masterclass is also Module 7 of the MSc.
MSCM72025F
01/04/2025
Regulatory Strategy for Established Active Substances
This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of and the strategic issues to be considered in relation to medicines containing established active substances, including line extensions, generics and the relevant aspects for over-the-counter (OTC) products. It will allow them to examine the regulatory requirements imposed on these substances. This Masterclass is also Module 7 of the MSc.
MSCM72025O
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