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Courses at this level are for people at senior level taking on additional responsibilities or looking to diversify their skills.
Critically Evaluating Dossiers
This course will help you critically analyse dossiers by understanding the importance of helping the assessor find pivotal information, as well as the importance of having consistent messages across Module 2, and between the summaries and the documents of Module 3-5.
Regulatory Strategy for a New Active Substance: Nonclinical
This Masterclass will give delegates an understanding of the practical and legislative requirements for the nonclinical 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 is also Module 2 of the TOPRA MSc Regulatory Affairs.
Regulatory Requirements for a New Active Substance: Quality
This Masterclass will help you understand and provide advice on quality data requirements in the pharmaceutical regulatory environment as well as addressing practical regulatory questions in this area. This is also Module 3 of the TOPRA MSc Regulatory Affairs.
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 is also Module 12 of the TOPRA MSc Regulatory Affairs.