Our team has two experienced EudraVigilance official EMA trainers, with 14 years of experience in this area. They can assist with case processing, assessment of database validation, and internal training. All done to ICH E2B(R3) and M2 Specifications.
Whether needed in either E2B(R3) or E2B(R2) format, we will help your organisation successfully transmit its ICSRs.
We will register all applicable persons in your headquarters, affiliates, and third parties to the EudraVigilance database.
Collect and transmit medicinal product and substance information to the eXtended EudraVigilance Medicinal Product Dictionary (Article 57 database) for both authorised and development medicinal products.