A team of experienced medical and pharmacovigilance experts can provide consultancy on a range of pharmacovigilance topics.
System Review and Optimisation
A comprehensive, compliant pharmacovigilance system to monitor benefit / risk profiles of medicinal products throughout development and post-marketing is a fundamental requirement for the protection of patients and public health. Indeed effective pharmacovigilance ensuring communication of the best ways to use medicinal products can protect the products from misuse and help keep them on the market.
Our experienced and expert consultants can review your system, identify any gaps and advise how to optimise your processes, so that the daily workflow allows accurate reporting within regulatory timeframes. We can help to implement necessary changes; draft and implement SOPs; monitor change control processes and provide all the necessary documentation to support and validate the changes.
Pharmacovigilance Audits and Inspection Preparedness
Companies are expected to routinely audit their system. Audits should extend to contractors and partners in Safety Data Exchange Agreements. In smaller companies, there may not be a Quality Assurance (QA) department, or perhaps your QA personnel do not have the experience or knowledge to carry out an in-house audit.
DSSL offers an external independent auditor to carry out routine audits, assist your QA staff or to perform pre-inspection audits of the company, sub-contractors and/or partners. We offer pre-inspection training (see TRAINING) to boost the confidence and performance of staff during inspections.
Finally, we can assist with preparation and implementation of the post-audit or post-inspection Corrective and Preventive Action Plan (CAPA).
As regulations change, then databases must change to stay in compliance. User requirements change, so then must databases change. Our team, with experience of various databases can help with the specification, validation and implementation of databases to support compliant pharmacovigilance systems.
Alternatively, we can accommodate your data in our own database, giving you access should you require it. We can offer a fully validated pharmacovigilance database (PV Works), thus taking all the hassle of set up, validation, maintenance and actual data entry off your shoulders.
“If it is not written down, it didn’t happen.” “If it’s not in an SOP it won’t happen.”
Standard Operating Procedures (SOPs) are an essential component of a compliant pharmacovigilance system, ensuring that regulatory obligations are fulfilled, that relevant personnel are performing the necessary tasks in a consistent manner and that compliance is measured and documented.
We can assist in preparation, implementation and training of your company SOPs. When it comes to assisting with specific pharmacovigilance tasks, then DSSL has a complete suite of SOPs covering all activities, that interface with the client SOPs and client specific SOPs detailing that interface.
Risk Management Plans
These specialist documents should conform to the template published by the EMA, however, a large number are still returned with many requests for update and expansion. DSSL can assist in preparation of these tricky documents, or with provision of the necessary data, may prepare a mature draft and lead the company through successful finalisation together with the relevant Regulatory Authority.