PV003: SOP FOR SAFETY DATA EXCHANGE AGREEMENTS (SDEA) & PARTNER RESPONSIBILITIES
OBJECTIVE: To define the procedure for establishing, reviewing, approving, and maintaining Safety Data Exchange Agreements (SDEA) with all partners involved in safety-related activities. To ensure compliance with World Health Organization (WHO) and European Union Good Pharmacovigilance Practices (EU-GVP) requirements. To clearly define safety responsibilities between the company and external partners for the exchange, reporting, and […]