Pharmacovigilance System / Process Development & Training
Developing a pharmacovigilance system to meet global regulatory requirements can be a daunting prospect. Pharmacovigilance systems can involve multiple departments within an organisation, multiple vendors, and a complex network of distribution and licence partners.
Mapi’s pharmacovigilance team has extensive experience of working with clients to develop roadmaps for pharmacovigilance systems; often looking several years into the future as a company plans to expand, moving from development to marketing and expanding into different jurisdictions. We have also worked with companies after the acquisition of new products, and after acquisitions and mergers of organisations when multiple pharmacovigilance systems have to be merged.
We can assist with:
- Developing a strategy for the development and evolution of a pharmacovigilance system;
- Developing a SOP matrix;
- Preparation of SOPs;
- Managing the implementation of a new/revised pharmacovigilance system.
Critical to the development and maintenance of any pharmacovigilance system is a pharmacovigilance team who is fully trained for their roles and responsibilities. Mapi’s pharmacovigilance team has a long history of providing training in Good Pharmacovigilance Practices, including:
- Basic pharmacovigilance requirements for all employees and consultants, including the identification of adverse events and requirements to forward to the central pharmacovigilance contact point;
- Training in clinical trial adverse event management for clinical teams and investigators;
- Training on adverse event management in non-interventional studies for clinical teams and investigators;
- Pharmacovigilance requirements for sales representatives, medical science liaisons and marketing and market research teams;
- What a regulatory affairs professional needs to understand in relation to pharmacovigilance legislation;
- In-depth training on Good Pharmacovigilance Practices pre- and post-approval for the pharmacovigilance professional.
Mapi can provide training that is tailored to requirements and which can be provided by webinar or in-house. Examples of Mapi’s webinars can be found here.