Pharmacovigilance and Risk Management
Mapi provides a flexible, global pharmacovigilance service supporting regulatory compliance and management of patient safety issues. We offer a full suite of pre- and post-marketing solutions throughout the product lifecycle from phase I-III clinical trials to observational studies and all aspects of the post-marketing environment.
Our experienced pharmacovigilance professionals are located in Europe and North America and are accustomed to working across the global regulatory environment. Mapi’s pharmacovigilance group is supported by the wider further Mapi community, giving access to a broad range of regulatory experts, epidemiology experts and Late Phase study experts. This unique arrangement provides the opportunity for pharmacovigilance activities to be taken to the next level as regulatory agency demands increase to ever more challenging levels.
Mapi is very proud of the loyalty our clients demonstrate in our pharmacovigilance services, having worked with some clients for more than 10 years and with multiple contracts originating from client referrals. Mapi’s pharmacovigilance system is supported by a quality management system that is certified to ISO 9001:2008.
Our clients engage us in a variety of ways from outsourcing their entire pharmacovigilance system to asking us to provide key activities to supplement their in-house resources. Examples include:
- Providing partial or full processing and submission of Individual Case Safety Reports of adverse events from clinical trial, observational study or post-marketing sources;
- Registering for and maintaining registrations for E2B submissions, e.g. via EudraVigilance.
- Preparation and submission of aggregate/periodic safety reports in all formats;
- Preparation of risk management plans, negotiation of risk management strategy with regulatory agencies, and execution of risk management strategies including Late Phase studies;
- Providing medical information services;
- Conducting Good Pharmacovigilance Practice inspections, audits and gap analyses;
- Providing EEA Qualified Person for Pharmacovigilance services;
- Preparation and maintenance of Pharmacovigilance System Master Files;
- Assisting with the development of pharmacovigilance systems, SOPs, and providing training in Good Pharmacovigilance Practices;
- Conducting global and local searches of the medical literature for the identification of Individual Case Safety Reports and general safety information.
Our experience includes pharmaceuticals, biologics, medical devices, OTC products, natural health products and drug/device combinations.