Pharmacovigilance Safety Reporting. The Parties shall meet to negotiate in good faith and agree on processes and procedures for sharing adverse event and other safety information related to the Product prior to any marketing or clinical activity governing pharmacovigilance obligations for the Product in the Territory. Such written plan (“Pharmacovigilance Agreement”) shall ensure that adverse event and other safety information are exchanged according to a schedule that will permit each Party to comply with legal and regulatory requirements in its respective territories. Provention shall establish the global safety database of adverse events and relevant safety information, including but not limited to pregnancy reports for the Product that will be used to support regulatory reporting, overall drug safety surveillance and responses to safety queries from Regulatory Authorities for their sponsored clinical trials.
Pharmacovigilance Safety Reporting. Institution and Investigator shall follow all pharmacovigilance requirements, as defined in the Protocol and by Applicable Law. 12.3
Pharmacovigilance Safety Reporting. Units Expedited Safety Report Submissions (assumes each expedited report requires 3 submissions) †† Services Included* * PVG safety reporting contracted services include set up and management, as applicable. Expedited and periodic safety report submissions. • Receive routine expedited safety reports from Galectin/third party (global safety reports relating to the concerned investigational medicinal product and comparator, regardless of originating protocol). • Coordinate submission of routine periodic safety reports to applicable regulatory authorities, ethics committees/institutional review boards/research ethics boards** and investigators, as indicated in the statement of services. ** Includes ethics committees, institutional review board and research ethics boards where Galectin has reporting responsibility. Assumptions • PPD has made standard general volume assumptions for budget purposes based on the North America region, not country-specific reporting requirements. Galectin will be invoiced based on actual submissions. • Costing includes the production of necessary cover letters, submission and tracking. • Pass-through charges will be incurred for postage/shipping/courier, third party electronic distribution tool transaction fees, translations, travel and meeting costs (e.g., teleconferences, materials), as applicable. • Galectin will grant PPD all necessary Power of Attorney to accomplish contracted safety reporting responsibilities. • PDF safety reports will be provided in Adobe format. • Unless otherwise directed by Galectin, all SUSARs will be deemed IND safety reports for the purposes of reporting within the US. • PPD utilizes a third-party, Web-based secure electronic distribution tool as the standard method for SUSAR reporting to investigator sites, providing enhanced security, traceability and efficiency over traditional distribution methods. The tool also has the flexibility to accommodate fax and e-mail distribution when required, for which additional pass-through charges may apply. • For efficiency, PPD submits reports remotely from central locations except in countries where this is not practical due to local regulatory requirements. In this situation, the submission will be made via a local PPD office or third-party vendor, incurring additional charges.
