Hi All,
Let’s understand about Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEA).
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| Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEA) |
Pharmacovigilance Agreements (PVAs)
A pharmacovigilance agreement (PVA) is a written agreement between the marketing authorisation holder (MAH) and a third party (to which the MAH has shared or activities regarding or impacting pharmacovigilance), which outlines the responsibilities of each party with regards to pharmacovigilance.
The detailed procedure of PVA in European Union (EU) is provided in Good Pharmacovigilance Practices (GVP) Module 1.
Purpose of Pharmacovigilance Agreements
Pharmacovigilance Agreement means an agreement entered into by the Parties to set forth the protocols and procedures for reporting adverse events and complying with reporting requirements set forth by Regulatory Authorities.
Types of PV Agreements
- Co-development arrangements
- Co-Marketing and Licensing
- Distribution and Wholesaler Agreements
- Manufacturing arrangements
- Purchase agreements/tenders/charitable donations
- Service level agreements
- Business service providers for marketing related activities
- Service providers for delegated PV activities or PV supporting functions
- Collaboration arrangement with not-for-profit organisation
- Operational aspects
Safety Data Exchange Agreements (SDEA)
Safety Data Exchange Agreements (SDEA) are legal written contracts ensuring that all safety data regarding a licensed product makes its way quickly and reliably back to the marketing authorization holder (MAH) so that they may fulfill their legal obligations to aggregate safety data and to submit safety reports in a timely manner.
Key Aspects to be covered in SDEA
- Definition of different terminologies and language of communication
- Mode of communication
- Products and territory for agreement
- Exchange of medical or product enquiries and quality complaints
- Exchange of cases – timelines and responsibilities
- Exchange of aggregate reports – timelines and responsibilities
- Exchange of validated signals – timelines, responsibilities, information on communication to regulatory authority
- Information on pharmacovigilance management system
- Reconciliation method and frequency
- Safety database
- Responsibility during regulatory inspections and Audit for PV
- Data privacy and confidentiality clause
- Business continuity plan (BCP)
- Termination clause
- Revision details – when and how
- Contact details such as phone number, email ID for communication of safety related details
Webinar on Pharmacovigilance Agreements
