Safety Data Exchange Agreements
Bpharma supports the development, review and management of Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) to support compliant, efficient and secure exchange of safety information.
Clear Agreements. Compliant Safety Data Exchange.
Key points
Why are PVAs/SDEAs important?
Well-defined SDEAs are essential for maintaining a compliant, efficient and well-controlled pharmacovigilance system, particularly when safety responsibilities are shared between multiple organisations.
- Regulatory compliance
- Helps ensure pharmacovigilance responsibilities and safety data exchange processes meet applicable global and local regulatory requirements.
- Clear roles and responsibilities
- Defines who is responsible for each PV activity, reducing the risk of gaps, duplication, missed activities or delayed reporting.
- Timely safety data exchange
- Establishes clear timelines and pathways for exchanging Individual Case Safety Reports (ICSRs) and other safety information to support regulatory reporting obligations.
- Quality and oversight
- Creates a structured framework for reconciliation, compliance monitoring, escalation, audits and ongoing oversight between partners.
- Seamless collaboration
- Establishes effective interfaces between Marketing Authorisation Holders (MAHs), licence partners, distributors, affiliates, service providers and other stakeholders.
- Business and portfolio growth
- Enables compliant PV operations as partnerships evolve through licensing, co-development, commercialisation, acquisitions and expansion into new markets.
Process
Our approach
Assess
Understand the partnership model, products, markets and regulatory requirements.
Draft / Review
Prepare or review SDEAs/PVAs with clear, compliant and practical terms.
Align
Collaborate with your legal, business and pharmacovigilance teams to finalise agreements.
Implement
Support execution, onboarding and operational readiness.
Maintain
Ongoing review and updates to reflect regulatory changes, new products or business activities.