Drug Safety and Pharmacovigilance Services

New requirements for drug safety monitoring introduced in recent years have added to the burden of compliance in terms of resources and expertise.

Spectrum Regulatory Solutions can help to ensure that pharmacovigilance (PV) systems, and procedures for new chemical entities, are properly established and that Marketing Authorisation Holders meet their obligations to monitor the safety of marketed products.

• Summary of Pharmacovigilance Systems (SPS), Detailed Description of Pharmacovigilance Systems (DDPS) Consultancy and report drafting
• Annual Safety Reports (ASRs) from ongoing clinical trials, as specified by the EU Clinical Trial Directive
• Periodic Safety Update Reports (PSURs) and related activities including legacy PSURs
• Signal evaluation and issue workups
• Benefit-Risk ratio review and assessment
• Harmonisation of CCDS/SmPC -International Birth Date (IBD) / Harmonised Birth Date (HBD)
• Harmonisation of PSURs
• Clinical expert statements
• Case narratives
• CIOMS IV benefit risk assessments
• Risk Management Planning
• Resolution and response to safety issues (e.g. Urgent Safety Restrictions [USRs])
• Weekly literature searching / Bespoke literature searching.

Useful links »