Control cost per episode within regulatory dossier management without shifting risk to patients.
Managing Regulatory Dossiers for Generic and Innovative Medicines
A working programme in regulatory dossier management for managers who have to deliver with existing resources.
📍 Tunis🗓️ 5 training days📚 4 modules🎓 Accredited certificate
5intensive training days
4scientific modules
8training sessions
32detailed points
Course Overview
Accreditation bodies assess regulatory dossier management on documented evidence of consistent practice. Cost pressure and quality expectations on the health and pharmaceutical services discipline are rising at the same time. They gain the ability to sequence improvements to the health and pharmaceutical services capability in an order their organisation can absorb. The difficulty is not agreeing that regulatory dossier management matters — it is deciding what to stop doing to make room for it. It establishes a shared vocabulary for this area of health and pharmaceutical services so that teams can disagree productively about it. Participants apply the health and pharmaceutical services discipline to their own clinical service throughout, so the output is directly usable. Organisations that document regulatory dossier management properly resolve disputes about it far more quickly. The programme works equally well for those formalising the practice within health and pharmaceutical services for the first time and those improving an existing approach. Work concludes with a self-assessment of the wider health and pharmaceutical services agenda that participants can repeat annually.
Expected Learning Outcomes
Build a register of the risks attaching to regulatory dossier management and keep it current.
Design a process for regulatory dossier management that clinical staff can follow without obstructing care.
Design escalation for clinical deterioration detected through regulatory dossier management.
Apply a repeatable review cycle to regulatory dossier management and act on what it produces.
Establish what evidence would demonstrate that regulatory dossier management is under control.
Plan continuity of regulatory dossier management during surge, outbreak and emergency.
Who Should Attend
Nursing managers and clinical supervisors delivering regulatory dossier management.
Infection prevention and control practitioners covering regulatory dossier management.
Members of committees that take decisions affecting regulatory dossier management.
Managers with direct responsibility for regulatory dossier management within the clinical service.
Clinical department heads responsible for regulatory dossier management.
Finance managers costing services delivered through regulatory dossier management.
Course Modules
Regulatory dossier management: staffing, capacity and demand
2 sessions · 8 pointsSession 1Medication safety checkpoints inside regulatory dossier management
- Map the handovers in regulatory dossier management between functions and secure them.
- Map the clinical workflow for regulatory dossier management as it is actually performed.
- Confirm competence and continuing development for staff delivering regulatory dossier management.
- Define escalation criteria for deterioration detected through regulatory dossier management.
Session 2Reading the current state of regulatory dossier management honestly
- Confirm licensing and regulatory requirements applying to regulatory dossier management are met.
- Record the rationale for each significant choice made about regulatory dossier management.
- Audit regulatory dossier management by observing practice, not by reading policy.
- Confirm the incident reporting route for regulatory dossier management is quick and non-punitive.
Regulatory dossier management: incident reporting, investigation and learning
2 sessions · 8 pointsSession 1Making incident reporting on regulatory dossier management safe for staff
- Confirm patient data handled within regulatory dossier management meets confidentiality obligations.
- Confirm that those complying with regulatory dossier management understand why it exists.
- Anticipate the objections regulatory dossier management will raise and prepare the answers.
- Match staffing levels on regulatory dossier management to measured demand across the week.
Session 2Choosing indicators for regulatory dossier management that reflect outcome
- Arrange the handover of regulatory dossier management so capability survives staff changes.
- Select quality indicators for regulatory dossier management that measure outcome rather than activity.
- Set the review interval for regulatory dossier management and who attends.
- Identify infection transmission risks created by regulatory dossier management and control them.
Regulatory dossier management: quality indicators and patient outcome
2 sessions · 8 pointsSession 1The decisions in regulatory dossier management that cannot be delegated
- Rank the weaknesses in regulatory dossier management by consequence rather than by ease of fixing.
- Reduce unwarranted variation in regulatory dossier management between shifts and sites.
- Prepare the summary of regulatory dossier management that senior management will read.
- Check that consent processes within regulatory dossier management are genuinely informed.
Session 2Closing out regulatory dossier management and capturing what was learned
- Identify single points of dependency in regulatory dossier management and reduce them.
- Confirm that reporting on regulatory dossier management reaches the people who can act.
- Define the trigger that would require regulatory dossier management to be redesigned.
- Draft the minimum viable clinical protocol for regulatory dossier management.
Regulatory dossier management: infection prevention and patient safety
2 sessions · 8 pointsSession 1Consent, confidentiality and ethics in regulatory dossier management
- Plan continuity of regulatory dossier management during surge and outbreak conditions.
- Build the competence framework that supports regulatory dossier management.
- Close the loop: confirm changes to regulatory dossier management improved the indicator they targeted.
- Assemble the accreditation evidence pack for regulatory dossier management.
Session 2Auditing regulatory dossier management at the bedside, not in the binder
- Measure patient experience of regulatory dossier management and feed it back to the team.
- Distinguish symptoms from causes when regulatory dossier management underperforms.
- Compare the cost of regulatory dossier management with the cost of its absence.
- Plan the sequence in which improvements to regulatory dossier management will be introduced.
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.