Yesterday the European Medicines Agency (EMA) provided an updated comprehensive guidance on EudraVigilance registration through its detailed "EudraVigilance Registration Manual". This manual is essential for stakeholders involved in pharmacovigilance activities within the European Economic Area (EEA). It provides a step-by-step guide to the registration process, ensuring stakeholders can effectively manage and report safety data.
EudraVigilance is an advanced system developed by the European Medicines Agency (EMA) for managing and analyzing information on suspected adverse reactions to medicines authorized in the EEA (European Economic Area).
It ensures continuous monitoring and proactive communication regarding the risk-benefit balance of medicines, thereby aiding in protecting patients' health.
The EudraVigilance Registration Manual is a comprehensive guide provided by the EMA that outlines the procedures for registering with EudraVigilance.
It's a vital resource for anyone involved in medicinal product development, marketing, and post-marketing surveillance. The manual provides detailed steps on several key processes:
User Registration: The manual walks users through the process of registering on the EudraVigilance system, which includes creating a user profile, and setting up an organization profile.
EudraVigilance Access Policy: The manual provides a detailed description of the EudraVigilance access policy. This policy delineates the roles and responsibilities of different user types and the access rights attached to each of them.
XCOMP Registration: XCOMP refers to the communication channel between EudraVigilance and various stakeholders. The manual guides setting up XCOMP registration and managing XCOMP certificates.
Pharmacovigilance System Master File (PSMF) Registration: The PSMF is a detailed description of the pharmacovigilance system used by the marketing authorization holder. The manual outlines the steps for PSMF registration in EudraVigilance.
User Management: The guide outlines how to manage users within an organization’s profile. This includes adding new users, editing existing user profiles, and deactivating users.
For a more in-depth understanding of the manual and its procedures, visit the EMA's official document.
Also, check out this EMA guidance on "Addendum to the Guideline on clinical development of vaccines to address clinical trials in immunocompromised individuals" that was recently released by EMA that aims to:
Provide additional guidance on clinical trial design for vaccines intended for immunocompromised individuals.
Highlight specific considerations for safety and efficacy assessments in this population.
The addendum to the EMA's guideline on clinical development of vaccines provides essential guidance for conducting clinical trials in immunocompromised individuals. For complete understanding, refer to the Addendum to the Guideline on Clinical Development of Vaccines.
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