Adoption of International Scientific Guidelines in Australia
Following an extensive internal and external consultation process, 13 international scientific guidelines have been adopted.
Clinical Trials Information System (CTIS) Sponsor Handbook
The Handbook addresses key questions on CTIS and provides a compilation and references to key guidance, technical information, recommendations, training materials, and supportive documentation to facilitate the submission and assessment of CTAs and additional information during the lifecycle of a trial.
What is the Windsor Framework?
The Windsor Framework secures the long-term stability of medicines supply to Northern Ireland, ensuring that medicines will be available in the same packaging across the UK. This means that new UK-wide arrangements for medicines come into effect on 1 January 2025.
Pharmacovigilance Following Agreement of the Windsor Framework
This guidance is designed to provide information on the implementation of changes to pharmacovigilance for medicines authorized in the UK following the agreement of the Windsor Framework.
Advertising and Promotion Following Agreement of the Windsor Framework
New arrangements for human medicines come into effect from 1 January 2025, reflecting the agreement on human medicines as part of the Windsor Framework. This guidance is designed to provide information on the implementation of changes to advertising and promotion of medicines authorised in the UK from 1 January 2025.
EudraVigilance - EVWEB User Manual
This user manual is part of the official documentation prepared by the European Medicines Agency (EMA) to support the use of the EudraVigilance Web reporting tool (EVWEB).
The user manual consists of 5 chapters:
Chapter 1 presents a comprehensive overview of the EVWEB application and should be read before the other chapters. It contains basic information regarding the structure, functions and use of EVWEB, which applies to all other sections and needs to be understood before moving on to the more advanced aspects of the system.
Chapter 2 describes the creation and transmission of Safety and Acknowledgement messages (ACKs), as well as the functions available in the WEB Trader, ICSRs, Post and Workspace screens.
Chapter 3 explains the integration of MedDRA in EVWEB and how to query the system for specific MedDRA terms.
Chapter 4 provides an insight into the administration tools available in EVWEB.
Chapter 5 lists the abbreviations and acronyms, along with their descriptions, introduced in this user manual.
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