Exploitant - Pharmaceutical Establishment
Pharmacovigilance
Customized PR and RPV support
- For the head pharmacist (PR) for managing the local pharmacovigilance system and liaising with the parent company
- For the pharmacovigilance reference person (RPV) for performing his/her duties
- Advice on PV organization or harmonization as part of Exploitant opening, reorganization, merger/integration
- Argument on the Exploitant’s position regarding Corporates
- Analysis of the impact of new regulations on PV functional organizations
- Support in setting up local or global processes: local signal detection, …
Organization's vigilance - QMS and compliance: creation, set-up, follow-up and improvement
- Drafting of the PV section of Exploitant opening file
- Drafting or reviewing your PSMF (global, local)
- Pharmacovigilance quality management system:
- Drafting and reviewing procedures tailored to your organization and product portfolio
- Gap analysis of SOPs
- Analysis and advice on improving your managing tools or PV documentation (monitoring table, data collection form, signal detection report, etc.).
Audits and Inspection in Vigilances
- Training and/or coaching of teams in PV inspection readiness, mock interviews
- Pre-inspection, gap analysis of PV system
- Conduct of system audits and specific process diagnosis (Subsidiary, Corporate)
- Audit and inspection follow-up
- Findings and action plan analysis, and actions prioritization
- Assistance with implementing and monitoring CAPAs
- Supporting improvement of the PV system
Tailormade in-company training courses (for various profiles within companies)
- Clinical trial vigilance
- Post-marketing pharmacovigilance
- Sales force training
- Regulatory news and impact on organizations (global, local)
- Qualification of service providers (review of qualification questionnaires, audit)
- Audit of PV service providers
- Analysis of Exploitant/supplier interface
- Review of contracts and specifications
Consultancy on the regulation of post-marketing pharmacovigilance and clinical trials
Further information
Atessia will support you in your pharmacovigilance activities thanks to its extensive experience in both corporate and subsidiary organizations and through exclusive support for Head Pharmacists in both training and preparing inspections.