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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
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
16/09/2025
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 Paediatric Regulation
This Masterclass will enable delegates to understand the legislative framework and practical aspects of the EU Paediatric Regulation and considerations around designing paediatric clinical trials.
M230525F2F
12/05/2025
The EU Paediatric Regulation
This Masterclass will enable delegates to understand the legislative framework and practical aspects of the EU Paediatric Regulation and considerations around designing paediatric clinical trials.
M230525O
30/07/2025
Regulatory Environment in the Middle East and North Africa
This Masterclass provides regulatory affairs professionals with a comprehensive introduction to the evolving regulatory landscape in the Middle East and North Africa (MENA). Designed to deepen your understanding of regional frameworks and operational requirements, this course explores the unique challenges and opportunities across MENA markets. You’ll gain the insights needed to navigate this complex environment and place regional developments within a broader global context.
M240725F2F
30/07/2025
Regulatory Environment in the Middle East and North Africa
This Masterclass provides regulatory affairs professionals with a comprehensive introduction to the evolving regulatory landscape in the Middle East and North Africa (MENA). Designed to deepen your understanding of regional frameworks and operational requirements, this course explores the unique challenges and opportunities across MENA markets. You’ll gain the insights needed to navigate this complex environment and place regional developments within a broader global context.
M24300725O
07/10/2025
The Regulatory Environment in South/East Asia
This Masterclass will provide you with an understanding of the regulatory landscape across South/East Asia. This Masterclass is also Module 25 of the MSc.
M2525F2F
07/10/2025
The Regulatory Environment in South/East Asia
This Masterclass will provide you with an understanding of the regulatory landscape across South/East Asia. This Masterclass is also Module 25 of the MSc.
M2525O
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
24/03/2026
The US Regulatory Environment
This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of regulatory operations in the US. This is also Module 11 of the TOPRA MSc Regulatory Affairs.
MSCM1126F
24/03/2026
The US Regulatory Environment
This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of regulatory operations in the US. This is also Module 11 of the TOPRA MSc Regulatory Affairs.
MSCM1126O
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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