Pharma and Biotech organizations come in different shapes and sizes. We understand this reality, and more importantly, we shape our services for each client’s specific pharmacovigilance needs.
This is especially true with our Local QPPV Services solutions. We can provide local contact person for pharmacovigilance services to cover many continents, but more importantly, the planning and rollout of services is what allows our clients to see and feel the real value they will experience.
Rolling out a Local QPPV Services project has numerous variables. iVigee makes sure our clients are well-aware of these variables and the cost-reduction possibilities.
Some of the important cost-related variables:
- Which countries REQUIRE a local QPPV resource?
- Which countries DO NOT REQUIRE a local QPPV resource?
- What are the specific time periods when the MAH must have a resource registered with local authorities? (upon MAA submission, approval, or product launch)
Understanding local PV requirements, and optimizing your PV System to meet what is needed will ultimately reduce expenses significantly. (EU Specific QPPV Details - full PDF)
Coordinated Local QPPV Services Include:
- One point of contact (iVigee QPPV Services Project Manager)
- Seamless integration with your PV system
- Ready for CAP & NP products
- Fast and flexible implementation
- Local Literature search
- Affiliate service
Local QPPV Responsibilities Include:
- Registration with local regulatory authorities (being the primary contact point)
- Local regulatory intelligence monitoring
- Availability to the MAH (and EU QPPV for EU PV projects)
- Collection and forwarding of safety information
- Preparation of monthly reports
- Completion of project specific training(s)
- Audit support and participation
- Implementation of local risk minimization measures
- Case follow up attempts
- Local language translation of relevant documentation
- Deputy services
For more information about our local QPPV services, feel free to contact iVigee at email@example.com
You can download our Local QPPV & Deputy Services which is specific to the EU Region here.