Fulfilling your regulatory obligations require different skills: interpreting the medical data provided by the reporter, collecting additional data in most of the cases, adequate coding, writing a comprehensive narrative. Knowing the regulations in terms of reporting (in accordance with the Notice to Marketing Authorisation Holders issued by the European Medicines Agency (EMA) and the specific requests of the different European Agencies. According to Volume 9A of The Rules Governing the Medicinal Products in the EU, the Marketing Authorisation Holder (MAH) should: Appoint a Qualified Person for Pharmacovigilance (QPPV) AND a Deputy QPPV (see instructions for Belgium).
Have a complete set of Standard Operating Procedures
Have a detailed description of the pharmacovigilance system (DDPS)
Organize regular training for the Sales Force and for the Administrative personnel in-house (See footnote)
Be prepared for an audit of your authorities. MedicalSigma recently assisted a medium size company to implement corrective actions after a audit. A valuable training tool !
Report adverse events electronically via Eudravigilance and keep adequate filing records
Prepare and submit Periodic Safety Update Reports (PSURs) to the national competent authorities
Prepare a Risk Management Plan (See EMA guidelines)
Prepare and submit an Annual Safety Report (ASR) for the ongoing clinical trials (See Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use).
What is the solution for the Small and Medium Size companies?
EVWEB is specifically designed for Small and Medium Size Enterprises (SMEs), which do not have a fully ICH E2B (R2) compliant pharmacovigilance system. It provides the tool (including a version of the MedDRA dictionary) to allow SMEs secure electronic reporting to the EMEA and all Competent Authorities in the EEA. EVWEB allows the sending and receiving of safety and acknowledgement messages in compliance with the latest ICH M2 standards. It also allows the saving of all messages at the local computer as well as the standardization of message senders and receivers registered with the EMA as part of the EudraVigilance community. Your company can be registered in the Eudravigilance database (as MAH or study sponsor) and we can act as third party provider to fulfill your regulatory obligations.