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There are legal and compliance issues at stake in the agreements between you and your suppliers, so good management of that process is critical.
Marketing Authorisation Holders (MAHs) bear full legal responsibility for the system they operate both for their already authorised medicinal products, or products in the application stage, but MAHs regularly contract parts of those obligations out to other parties, which can be for efficiency, expertise, speed etc., which is why the need for good Pharmacovigilance Partnerships Management becomes an essential operational necessity.
Pharmacovigilance Partnerships Management is an end-to-end process starting from collection of source data through drafting and negotiation of agreement to tracking and maintaining all agreements current and all team members informed about the responsibilities as these may differ from routine practice. Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs) are common legally binding industry wide formats used for this, clearly identifying who is responsible for what.
PVAs cover broad aspects of pharmacovigilance activities depending on particular business needs, are typically concluded between two parties, for example, product co-development with another Applicant/MAH, distribution agreements with vendors, or service-level commitments with expert PV providers like iVigee, but time to time may involve three (or even more) parties.
Whilst making it clear, that MAH retains the responsibility for the all pharmacovigilance system even if some activities are delegate, SDEAs are designed to guarantee the efficient exchange of many types of pharmacovigilance safety data which can include individual Case Safety reports (ICSRs), Aggregate Reports, Signal Management, Literature Monitoring and others. This data is of course critical for a MAH’s compliance with regulatory obligations and to maintain patient safety.
Drafting and negotiating PVAs and SDEAs in line with regulatory requirements and internal procedures (clients’ or iVigee’s).
A clear responsibility matrix.
The day to day management, tracking, and regular review of PVAs and SDEAs.
The distribution of key elements of a PVA or SDEA after sign-off to the PV team.
Training on the obligations and requirements of PVAs and SDEAs.
Establishing standard processes within the agreement's scope.
Pharmacovigilance auditing to ensure the compliance of partners with a PVA or SDEA.
iVigee has extensive experience with Pharmacovigilance Partnership Management, having collectively negotiated and agreed hundreds of effective PVAs and SDEAs for a broad range of requirements and international settings.
We have fully developed and proven PVA and SDEA templates which we can tailor to your specific situation.
Having clear and thorough partnership agreements is critical to the successful collaboration between businesses, and we use our depth of expertise and attention to detail to ensure your needs are fully met, even under extreme time-constraints.
Choosing iVigee for Pharmacovigilance Partnerships Management guarantees you’ll benefit from a professional team that creates innovation, sustainability, and trust across every aspect of the partnerships process.
