• Standard Operating Procedures
  • PV Training
  • PV Agreements

We establish and maintain quality-assured pharmacovigilance systems and solutions adapted to the Client’s organization that are in compliance with regulatory requirements and are designed to monitor the safety of products and detect any change to their risk-benefit balance. This includes the development and/or review of standard operating procedures and work instructions, compliance management, and record management.

Our experienced PV trainers help Clients achieve in-depth understanding and quality required for the conduct of pharmacovigilance processes by providing customized initial and continued on-site or remote training to their personnel.
service-icons-systems

Our experienced PV trainers help Clients achieve in-depth understanding and quality required for the conduct of pharmacovigilance processes by providing customized initial and continued on-site or remote training to their personnel. Staff directly performing pharmacovigilance activities are trained in applicable pharmacovigilance legislation and guidelines, as well as specific training in report processing activities. Training is also provided to other company personnel who have not been assigned any specific pharmacovigilance tasks and responsibilities but whose activities may have an impact on the pharmacovigilance processes within the company.

When a marketing authorization holder intends to establish a partnership with another company or organisation that has an impact on the pharmacovigilance system, our team develops and maintains a robust contractual agreement, ensuring that all provisions relevant to the global pharmacovigilance system of the partners are included in the agreement.