New requirements for safety monitoring for pharmaceuticals introduced in recent years have added to the burden of compliance in terms of resources and expertise.
Pharmacovigilance Systems and Documentation
Pharmacovigilance has recently undergone significant legislative developments in the EU. Spectrum can help to ensure that pharmacovigilance (PV) systems are properly established and ensure that Marketing Authorisation Holders meet their obligations to monitor the safety of marketed products in this rapidly-changing arena. We can help upgrade existing systems to full compliance with the new legal requirements. Preparation of PV Standard Operating Procedures (SOPs) is a speciality.
Our services, in collaboration with our network of partners, include:
- Safety processes and SOPs
- QPPV and Deputy QPPV services for clients entering or currently working in the EU Zone
- Safety Data Exchange Agreements (SDEA), Risk Management Planning (RMP) and Consultancy
- Periodic Safety Update Reports (PSURs) / Periodic Benefit Risk Evaluation Reports (PBRERs) and related activities including PSUR harmonisation and legacy PSURs
- Signal detection and evaluation, and issue workups
- Benefit-Risk review and re-assessment
- Clinical Expert Statements
- Case narratives
- Weekly and bespoke literature searching using PUBMED, EMBASE, MEDLINE and other databases as required
- Review of literature to identify individual case safety reports (ICSRs) for inclusion in the PSUR
- Pre- and post-inspection support, including:
- Audit and inspection preparation
- Objective review of current systems, processes and documentation to identify weaknesses or gaps
- Implementation of corrective and preventative actions
To find out more about these and other services from Spectrum, please call us on +44 (0)1403 320280 or contact us by email.