Pharmacovigilance
Audits
DADA can support you when preparing for an audit or inspection. DADA can also conduct pharmacovigilance audits for you, e.g., at your affiliates or partners, either remote or on site, or conduct a mock-inspection of your internal PV system. Activities include a risk-based assessment of the auditee, the conduct of the audit by experienced DADA staff members and the writing of an audit report with the findings identified.
Services
Other services in Pharmacovigilance
- 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
- Veterinary PV support
- XEVMPD population and maintenance
Business hours
- Monday – Friday
- 9am – 5pm
- Saturday
- Closed
- Sunday
- Closed