Audit pharmaceutical regulatory compliance in practice, not only in policy.
Compliance with International Pharmaceutical Regulatory Authority Requirements
A senior-level treatment of pharmaceutical regulatory compliance, focused on what changes outcomes.
📍 Tunis🗓️ 5 training days📚 4 modules🎓 Accredited certificate
5intensive training days
4scientific modules
8training sessions
32detailed points
Course Overview
The data supporting pharmaceutical regulatory compliance is usually present but rarely assembled into a decision. Accreditation bodies assess this part of health and pharmaceutical services on documented evidence of consistent practice. It suits anyone whose decisions touch this area of health and pharmaceutical services, in large organisations and small ones alike. The programme is built to be used, and every section of pharmaceutical regulatory compliance it covers ends in something applicable. Participants develop a defensible line of reasoning for the choices they make about this strand of health and pharmaceutical services. Ambition around this part of health and pharmaceutical services outruns capacity unless the sequencing is deliberate. Mature organisations treat pharmaceutical regulatory compliance as a standing capability rather than a project that finishes. Exercises escalate in difficulty, ending with the ambiguous situations that make the practice within health and pharmaceutical services hard in practice. The final module sets out how progress on this area of health and pharmaceutical services will be evidenced six months later.
Expected Learning Outcomes
Apply a repeatable review cycle to pharmaceutical regulatory compliance and act on what it produces.
Prepare a short, evidence-based briefing on pharmaceutical regulatory compliance for senior management.
Apply root cause analysis to adverse events involving pharmaceutical regulatory compliance.
Plan staffing and rota cover appropriate to demand in pharmaceutical regulatory compliance.
Manage the supply chain and cold chain supporting pharmaceutical regulatory compliance.
Build the internal capability for pharmaceutical regulatory compliance rather than depending on external support indefinitely.
Who Should Attend
Health information and records staff supporting pharmaceutical regulatory compliance.
Regulatory affairs specialists handling pharmaceutical regulatory compliance.
Pharmacists and pharmacy managers involved in pharmaceutical regulatory compliance.
Quality staff verifying that pharmaceutical regulatory compliance performs as designed.
Accreditation and compliance officers preparing evidence on pharmaceutical regulatory compliance.
Staff seconded into improvement work on pharmaceutical regulatory compliance.
Course Modules
Pharmaceutical regulatory compliance: confidentiality, consent and ethics
2 sessions · 8 pointsSession 1Where pharmaceutical regulatory compliance typically breaks, and why
- Estimate the resource pharmaceutical regulatory compliance requires to run as designed.
- Prepare the summary of pharmaceutical regulatory compliance that senior management will read.
- Review whether pharmaceutical regulatory compliance is aligned with the objectives of the clinical service.
- Confirm licensing and regulatory requirements applying to pharmaceutical regulatory compliance are met.
Session 2Auditing pharmaceutical regulatory compliance at the bedside, not in the binder
- Measure patient experience of pharmaceutical regulatory compliance and feed it back to the team.
- Agree the indicators that will show whether pharmaceutical regulatory compliance is improving.
- Write down the assumptions underpinning the approach to pharmaceutical regulatory compliance.
- Establish who is informed, consulted and accountable in pharmaceutical regulatory compliance.
Pharmaceutical regulatory compliance: clinical process design and workflow
2 sessions · 8 pointsSession 1Matching staffing on pharmaceutical regulatory compliance to real demand
- Assign responsibility for keeping documentation of pharmaceutical regulatory compliance current.
- Verify cold chain and storage conditions for materials used in pharmaceutical regulatory compliance.
- Plan the sequence in which improvements to pharmaceutical regulatory compliance will be introduced.
- Confirm competence and continuing development for staff delivering pharmaceutical regulatory compliance.
Session 2What has to be agreed before work on pharmaceutical regulatory compliance starts
- Apply structured root cause analysis to the last adverse event involving pharmaceutical regulatory compliance.
- Name a single owner for each element of pharmaceutical regulatory compliance.
- Build medication safety checks into pharmaceutical regulatory compliance at the point of highest risk.
- Identify the data already collected that bears on pharmaceutical regulatory compliance.
Pharmaceutical regulatory compliance: incident reporting, investigation and learning
2 sessions · 8 pointsSession 1Consent, confidentiality and ethics in pharmaceutical regulatory compliance
- Map the clinical workflow for pharmaceutical regulatory compliance as it is actually performed.
- Audit pharmaceutical regulatory compliance by observing practice, not by reading policy.
- Prepare the response for the most likely failure in pharmaceutical regulatory compliance.
- Identify where judgement in pharmaceutical regulatory compliance is legitimate and where it is not.
Session 2Choosing indicators for pharmaceutical regulatory compliance that reflect outcome
- Check that consent processes within pharmaceutical regulatory compliance are genuinely informed.
- Test the procedure for pharmaceutical regulatory compliance against a realistic scenario.
- Plan continuity of pharmaceutical regulatory compliance during surge and outbreak conditions.
- Verify six months later that changes to pharmaceutical regulatory compliance have held.
Pharmaceutical regulatory compliance: medication and treatment safety
2 sessions · 8 pointsSession 1The decisions in pharmaceutical regulatory compliance that cannot be delegated
- Reduce unwarranted variation in pharmaceutical regulatory compliance between shifts and sites.
- Select quality indicators for pharmaceutical regulatory compliance that measure outcome rather than activity.
- Agree the smallest change to pharmaceutical regulatory compliance that would be visibly useful.
- Confirm patient data handled within pharmaceutical regulatory compliance meets confidentiality obligations.
Session 2Infection risk created by pharmaceutical regulatory compliance
- Identify infection transmission risks created by pharmaceutical regulatory compliance and control them.
- Define escalation criteria for deterioration detected through pharmaceutical regulatory compliance.
- Compare the cost of pharmaceutical regulatory compliance with the cost of its absence.
- Confirm the incident reporting route for pharmaceutical regulatory compliance is quick and non-punitive.
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
Complete your registration
We will contact you within one business day to confirm.