Is there some area of pharmacovigilance where you lack resource or expertise? The DSSL team has experience of all aspects of pharmacovigilance and is able to assist or provide support in one or more areas…
Qualified Person for Pharmacovigilance (QPPV)
All Market Authorisation Holders are required to have a Qualified Person responsible for pharmacovigilance in the EEA. The QPPV must be experienced in all aspects of pharmacovigilance, live in the EEA and be available 24/7/365.
DSSL can offer fully experienced persons to act as the QPPV or deputy, providing a company with full support in order to meet the necessary requirements, from the first submission of a Market Authorisation and throughout the product lifetime.
Pharmacovigilance System Master File (PSMF)
At DSSL we have prepared the PSMF for many clients, whether or not we provide the pharmacovigilance service. We advise if you are unsure or do not have the time; alternatively we can prepare and / or maintain your PSMF.
Periodic Reports (DSURS, PSURS/PBRERS, Management Reports)
DSSL personnel have experience of writing and reviewing many periodic reports. We can co-ordinate and oversee the due dates of the above mentioned pharmacovigilance reports in order to efficiently allocate resource and ensure that the reports are submitted to the Regulatory Authorities within the legislated timelines.
Safety Monitoring and Signal Detection
Inadequate or lack of safety monitoring is a common finding on inspection. This can be the most difficult area of compliance for generic companies and those with mainly older or simple OTC products. Let us help you design comprehensive yet straight forward processes for reviewing the safety of your products and documenting the process and outcomes to achieve compliance.
Safety Data Exchange Agreements
It is a rare company that doesn’t have at least one partner company. Regulations require that companies have in place agreements that detail how they will share data and ensure that pharmacovigilance obligations of each are performed without duplication of reporting. We can help you by preparing a company standard Safety Data Exchange Agreement and work with your staff and partners to complete and implement these important documents, and also assist in managing and maintaining them.
Clinical Trials and SUSARS
With years of experience in clinical trial pharmacovigilance, DSSL can offer effective management of clinical trial SAEs from receipt and case assessment, through expedited and electronic reporting to the regulatory authorities and preparation of Development Safety Update Reports (DSURs) and reconciliation.