Audit pharmacovigilance programmes in practice, not only in policy.
Managing Pharmacovigilance Programmes
Turn pharmacovigilance programmes from a stated policy into a practice your organisation can evidence.
📍 Tunis🗓️ 5 training days📚 4 modules🎓 Accredited certificate
5intensive training days
4scientific modules
8training sessions
32detailed points
Course Overview
Clinical staff will work around a process for pharmacovigilance programmes that obstructs care, and they will be right to. In healthcare, a weakness in this strand of health and pharmaceutical services is eventually paid for by a patient. Applied research in health and pharmaceutical services consistently shows that early structure around the health and pharmaceutical services capability reduces downstream rework. The programme takes participants through pharmacovigilance programmes end to end, from framing the problem to closing it out. What blocks progress on the practice within health and pharmaceutical services is usually unclear ownership rather than unclear intent. Participants apply this aspect of health and pharmaceutical services to their own clinical service throughout, so the output is directly usable. They leave able to brief senior management on pharmacovigilance programmes in terms that support a decision. The material serves both public bodies and commercial organisations dealing with this part of health and pharmaceutical services. Participants finish with a short, specific brief on this strand of health and pharmaceutical services ready to put in front of a decision maker.
Expected Learning Outcomes
Agree the first three actions on pharmacovigilance programmes that will be taken on returning to work.
Build the quality indicators for pharmacovigilance programmes that reflect patient outcome, not activity.
Test the organisation's response to pharmacovigilance programmes under conditions that are less than ideal.
Measure patient experience of pharmacovigilance programmes and act on what it shows.
Distinguish the parts of pharmacovigilance programmes that must be standardised from those that require judgement.
Design medication and treatment safety controls within pharmacovigilance programmes.
Who Should Attend
Those responsible for briefing external stakeholders on pharmacovigilance programmes.
Analysts producing the data on which decisions about pharmacovigilance programmes rest.
Health information and records staff supporting pharmacovigilance programmes.
Infection prevention and control practitioners covering pharmacovigilance programmes.
Clinical department heads responsible for pharmacovigilance programmes.
Finance managers costing services delivered through pharmacovigilance programmes.
Course Modules
Pharmacovigilance programmes: quality indicators and patient outcome
2 sessions · 8 pointsSession 1Matching staffing on pharmacovigilance programmes to real demand
- Map the clinical workflow for pharmacovigilance programmes as it is actually performed.
- Confirm patient data handled within pharmacovigilance programmes meets confidentiality obligations.
- Reduce the variation in how pharmacovigilance programmes is carried out between teams.
- Close the loop: confirm changes to pharmacovigilance programmes improved the indicator they targeted.
Session 2Moving pharmacovigilance programmes from approval to execution
- Plan continuity of pharmacovigilance programmes during surge and outbreak conditions.
- Select quality indicators for pharmacovigilance programmes that measure outcome rather than activity.
- Rehearse the briefing on pharmacovigilance programmes that would follow an incident.
- Measure patient experience of pharmacovigilance programmes and feed it back to the team.
Pharmacovigilance programmes: staffing, capacity and demand
2 sessions · 8 pointsSession 1Testing pharmacovigilance programmes before relying on it
- Confirm licensing and regulatory requirements applying to pharmacovigilance programmes are met.
- Identify infection transmission risks created by pharmacovigilance programmes and control them.
- Draft the minimum viable clinical protocol for pharmacovigilance programmes.
- Cost pharmacovigilance programmes per episode and identify avoidable waste.
Session 2Where pharmacovigilance programmes typically breaks, and why
- Check that pharmacovigilance programmes still works when volumes rise unexpectedly.
- Identify where judgement in pharmacovigilance programmes is legitimate and where it is not.
- Reduce unwarranted variation in pharmacovigilance programmes between shifts and sites.
- Apply structured root cause analysis to the last adverse event involving pharmacovigilance programmes.
Pharmacovigilance programmes: cost, efficiency and sustainability of the service
2 sessions · 8 pointsSession 1What patients actually experience during pharmacovigilance programmes
- Assemble the accreditation evidence pack for pharmacovigilance programmes.
- Estimate the resource pharmacovigilance programmes requires to run as designed.
- Match staffing levels on pharmacovigilance programmes to measured demand across the week.
- Confirm competence and continuing development for staff delivering pharmacovigilance programmes.
Session 2Consent, confidentiality and ethics in pharmacovigilance programmes
- Establish the boundary of pharmacovigilance programmes and record what sits outside it.
- Build medication safety checks into pharmacovigilance programmes at the point of highest risk.
- Name a single owner for each element of pharmacovigilance programmes.
- Test the procedure for pharmacovigilance programmes against a realistic scenario.
Pharmacovigilance programmes: medication and treatment safety
2 sessions · 8 pointsSession 1Making incident reporting on pharmacovigilance programmes safe for staff
- Anticipate the objections pharmacovigilance programmes will raise and prepare the answers.
- Check that consent processes within pharmacovigilance programmes are genuinely informed.
- Build the competence framework that supports pharmacovigilance programmes.
- Arrange the handover of pharmacovigilance programmes so capability survives staff changes.
Session 2The evidence assessors will ask for on pharmacovigilance programmes
- Record the rationale for each significant choice made about pharmacovigilance programmes.
- Confirm that contractual obligations around pharmacovigilance programmes are understood.
- Rank the weaknesses in pharmacovigilance programmes by consequence rather than by ease of fixing.
- Collect evidence on the present handling of pharmacovigilance programmes before proposing changes.
Choose the package that suits you
Silver Package
At least 3 people
USD1,250
- Workshop or Program Participation
- Airport Transfers
- Customized Badge
- Expert Mentorship (Private Sessions)
- Supervision & Secretarial Services
- Accredited Certificate of Participation
- Complete Training Kit
- Coffee Break
- Closing Ceremony
Gold Package
At least 3 people
USD1,850
- 5-night stay in a 5-star hotel
- Workshop or Program Participation
- Airport Transfers
- Customized Badge
- Expert Mentorship (Private Sessions)
- Supervision & Secretarial Services
- Accredited Certificate of Participation
- Complete Training Kit
- Coffee Break
- Closing Ceremony
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