Pharmacovigilance
Veterinary PV support
DADA also has extensive experience in the field of veterinary medicinal products (VMPs). Within the DADA PV department, we are offering a pharmacovigilance system for veterinary MAHs, as well as support in preparation for Competent Authority inspections.
Our PV system for VMPs is compliant with the new veterinary legislation and operates per specific procedures for veterinary products. We have a validated database for veterinary case processing. All our procedures, systems, and staff qualifications (including the (d)QPPV and our in-house veterinary doctor) are adequately described in the MAH-specific PV System Master File. Our staff has experience in the Union Product Database and the Union Pharmacovigilance database. We can conduct signal detection, evaluation and submit annual signal detection statements on your behalf. DADA can provide specific veterinary pharmacovigilance training including all changes with regards to the new legislation for employees of the client. Furthermore, we can support clients during audits or inspections or conduct a mock-inspection of your internal PV system.
Services
Other services in Pharmacovigilance
- Audits
- Communication with National Competent Authorities
- EU Qualified Person for Pharmacovigilance (QPPV)
- Expedited reporting
- Global and local literature screening and review
- ICSR/SUSAR processing
- Inspection readiness
- Local (QP)PV support and AE/MI/PQC processing
- Organisation set-up and changes
- Periodic safety reporting
- Post-Authorisation Safety Studies (PASS)
- PV SOPs and other controlled operating instructions
- PV System Master File (PSMF)
- Risk Management Plans (RMPs)
- Safety Data Exchange Agreements (SDEAs)
- Signal detection and evaluation – benefit/risk assessment in safety review meetings
- Training in pharmacovigilance
- XEVMPD population and maintenance
Business hours
- Monday – Friday
- 9am – 5pm
- Saturday
- Closed
- Sunday
- Closed