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Consolidate your regulatory competencies
Courses at this level are for experienced professionals committed to developing their regulatory and management competencies.
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10/03/2026
Compiling Successful Clinical Trial Applications
Gain a clear understanding of Clinical Trial Application (CTA) requirements across the EU and beyond, including the latest updates on the EU Clinical Trial Regulation 536/2014 and CTIS. Learn practical strategies for managing CTAs effectively through expert-led, interactive sessions.
CT26F
10/03/2026
Compiling Successful Clinical Trial Applications
Gain a clear understanding of Clinical Trial Application (CTA) requirements across the EU and beyond, including the latest updates on the EU Clinical Trial Regulation 536/2014 and CTIS. Learn practical strategies for managing CTAs effectively through expert-led, interactive sessions.
CT26O
21/04/2026
Project Management for Regulatory Affairs Professionals
A two-day course that strengthens your ability to manage regulatory projects, lead teams and deliver high-quality regulatory documents.
PM26F
06/05/2026
Vaccine Development: A Regulatory Perspective
This course focuses on the development of vaccines from a regulatory standpoint. It explores the unique complexities involved in Chemistry, Manufacturing, and Controls (CMC) for vaccines, the process of selecting adjuvants, and the role of neutralisation assays. Additionally, it covers non-clinical requirements and clinical trial design considerations. The program also examines the impact of COVID-19 on vaccine development and emphasizes strategies for preparing for future pandemics
CDVCON26
06/05/2026
Vaccine Development: A regulatory perspective
This course focuses on the development of vaccines from a regulatory standpoint. It explores the unique complexities involved in Chemistry, Manufacturing, and Controls (CMC) for vaccines, the process of selecting adjuvants, and the role of neutralisation assays. Additionally, it covers non-clinical requirements and clinical trial design considerations. The program also examines the impact of COVID-19 on vaccine development and emphasizes strategies for preparing for future pandemics
CRVDF2F26
12/05/2026
Managing Lifecycle and Variations Effectively
This course provides a clear overview of the EU variations regulation, with a focus on grouping and work-sharing procedures. Attendees will explore how to navigate the categorisation guidelines and discuss other critical actions needed for effective lifecycle management.
LCM26F
12/05/2026
Managing Lifecycle and Variations Effectively
This course provides a clear overview of the EU variations regulation, with a focus on grouping and work-sharing procedures. Attendees will explore how to navigate the categorisation guidelines and discuss other critical actions needed for effective lifecycle management.
LCM26O
10/06/2026
Successful and Skilful Communication
Master the communication and negotiation skills every regulatory professional needs. Learn to influence stakeholders, navigate complex interactions, and deliver presentations and documents that achieve results.
SSF2F26
21/07/2026
Successfully Navigating European Regulatory Procedures
This course is designed for individuals involved in developing European regulatory strategies for projects or wishing to gain the knowledge and skills to contribute to regulatory strategies.
ERP26F2F
21/07/2026
Successfully Navigating European Regulatory Procedures
This course is designed for individuals involved in developing European regulatory strategies for projects or wishing to gain the knowledge and skills to contribute to regulatory strategies.
ERP26O
02/09/2026
An Overview of Regulatory Product Information
Master the strategic development and practical implementation of regulatory product information in Europe and the UK through this hands-on course, featuring expert insights on SmPCs, labelling, and upcoming digital innovations.
SMPC26F2F
02/09/2026
An Overview of Regulatory Product Information
Master the strategic development and practical implementation of regulatory product information in Europe and the UK through this hands-on course, featuring expert insights on SmPCs, labelling, and upcoming digital innovations.
SMPC26O
15/09/2026
Getting the CMC Dossier Right
Ensure your CMC submissions meet current standards with this course, providing you with practical guidance on data expectations, common pitfalls, and best practices for preparing Module 3 of Marketing Authorisation Applications for synthetic molecules. Gain the insights needed to enhance compliance and streamline the approval process.
CMCF2F26
15/09/2026
Getting the CMC Dossier Right
Ensure your CMC submissions meet current standards with this course, providing you with practical guidance on data expectations, common pitfalls, and best practices for preparing Module 3 of Marketing Authorisation Applications for synthetic molecules. Gain the insights needed to enhance compliance and streamline the approval process.
CMCO26
13/10/2026
Understanding Clinical Development
Develop a clear understanding of how effective clinical trials are designed, drawing on practical perspectives from regulators and industry. This course addresses key considerations for planning and conducting clinical trials from phase I through phases II and III, and for supporting regulatory expectations beyond initial marketing approval.
CD26O
13/10/2026
Understanding Clinical Development
Develop a clear understanding of how effective clinical trials are designed, drawing on practical perspectives from regulators and industry. This course addresses key considerations for planning and conducting clinical trials from phase I through phases II and III, and for supporting regulatory expectations beyond initial marketing approval.
CUCDF2F26
10/11/2026
Optimising Regulatory Strategies for Orphan Drugs
Discover the strategies and insights needed to navigate orphan drug regulations effectively. This course provides essential guidance on regulatory processes that accelerate development and access, along with first-hand advice on how to maximise opportunities for rare disease medicines.
CODON
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