Pharmacovigilance Agreement Sop
It is important to develop agreements defining the responsibilities of each partner with regard to each of the pharmacovigilance activities. A professional SDEA ensures compliance with legal rules and avoids double pharmacovigilance activities on the part of different partners. Contact us. We can set up your pharmacovigilance system, including all necessary documentation (Pharmacovigilance System Master File, SOPs), in accordance with applicable rules and national and international standards. We can also assist you in the maintenance of such a system We have extensive experience in the development of pharmacovigilance operating procedures such as standard operating procedures (SOPs), work instructions and safety management plans. We also help you review and update existing procedures. We can help you register in the EudraVigilance system in order to comply with ICSR`s electronic reporting obligations in E2B format, as well as when transmitting data to the expanded eudraVigilance Medicinal Product Dictionary (XEVMPD). . . .