Aggregate Report Writing
Provision of wide range of pharmacovigilance aggregate report writing services, including:
PBRER (and response to PSUSA), PSUR, Addendum Clinical Overview, DSUR and RMP. All reports are drafted according to local applicable regulatory guidelines and regulations.
Tasks performed include report drafting, QC and formatting. Literature review and analysis, safety evaluations and risk-benefit assessments conducted as required. Submission via EMA repository if required.
Full product review and harmonisation projects. Creation of product-specific supporting documentation for maintenance and update of Company Core Data Sheet / local product updates / safety variations,
e.g. Clinical Overviews, Non-Clinical Overviews, Clinical Expert Statements, Synthesis documents. Responses to regulatory agency queries.
Tailor-made support packages designed for markets impacted as required.
Audit preparation and support for both internal and externally driven regulatory authority inspection
Generation of CAPA report post-audit and development of implementation timelines and plan
PV department set-up support to ensure compliance with regulatory requirements
Tailor-made training including pharmacovigilance procedures and processes, GVP modules, Aggregate Reports, RMPs, Literature review etc.
Ad-hoc consultancy requests based on client requirements
Signal management - signal assessments conducted for validation of potential signals as per GVP Module IX
Literature review and analysis in accordance with GVP Module VI - provision of classification, sorting of results and comprehensive overview of search results. In addition, screening of literature for aggregate report inclusion, signal assessment purposes, product reviews or for other ad-hoc requests can also be performed.
PSMF creation and maintenance as per GVP Module II
SOP/WIN/Template creation and / or review as required