Establish escalation routes for international research compliance that work outside normal hours.
Managing Regulatory Compliance for International Clinical Research
A working programme in international research compliance for managers who have to deliver with existing resources.
📍 Istanbul🗓️ 5 training days📚 4 modules🎓 Accredited certificate
5intensive training days
4scientific modules
8training sessions
32detailed points
Course Overview
The data supporting international research compliance is usually present but rarely assembled into a decision. Accreditation bodies assess this strand of health and pharmaceutical services on documented evidence of consistent practice. The content is relevant to those who own the health and pharmaceutical services capability and to those who are held accountable for its results. Discussion is anchored to worked examples of international research compliance rather than to abstract argument. The course sets out a working method for the practice within health and pharmaceutical services that participants can apply the week they return. The difficulty is not agreeing that this strand of health and pharmaceutical services matters — it is deciding what to stop doing to make room for it. Participants gain a realistic view of what international research compliance costs and what it returns. Field experience suggests that the barrier to better this area of health and pharmaceutical services is rarely technical. Participants finish with a short, specific brief on this part of health and pharmaceutical services ready to put in front of a decision maker.
Expected Learning Outcomes
Assess and control infection risk associated with international research compliance.
Distinguish the parts of international research compliance that must be standardised from those that require judgement.
Protect patient confidentiality and data within international research compliance.
Prepare the documented evidence accreditation assessors expect on international research compliance.
Apply root cause analysis to adverse events involving international research compliance.
Draw practical lessons from failures in international research compliance without assigning blame that suppresses reporting.
Who Should Attend
Nursing managers and clinical supervisors delivering international research compliance.
Quality and patient safety officers monitoring international research compliance.
Staff seconded into improvement work on international research compliance.
Medical directors overseeing clinical governance of international research compliance.
Regulatory affairs specialists handling international research compliance.
Analysts producing the data on which decisions about international research compliance rest.
Course Modules
International research compliance: quality indicators and patient outcome
2 sessions · 8 pointsSession 1The hard cases in international research compliance and how to reason about them
- Audit international research compliance by observing practice, not by reading policy.
- Plan the sequence in which improvements to international research compliance will be introduced.
- Match staffing levels on international research compliance to measured demand across the week.
- Remove steps in international research compliance that add effort without adding assurance.
Session 2Investigating an adverse event involving international research compliance
- Select quality indicators for international research compliance that measure outcome rather than activity.
- Reduce the variation in how international research compliance is carried out between teams.
- Define escalation criteria for deterioration detected through international research compliance.
- Agree what will be standardised in international research compliance and what will not.
International research compliance: regulation, licensing and accreditation evidence
2 sessions · 8 pointsSession 1Infection risk created by international research compliance
- Verify six months later that changes to international research compliance have held.
- Assemble the accreditation evidence pack for international research compliance.
- Apply structured root cause analysis to the last adverse event involving international research compliance.
- Plan continuity of international research compliance during surge and outbreak conditions.
Session 2Designing international research compliance so it helps rather than obstructs care
- Close the loop: confirm changes to international research compliance improved the indicator they targeted.
- Map the clinical workflow for international research compliance as it is actually performed.
- Reduce unwarranted variation in international research compliance between shifts and sites.
- Confirm the incident reporting route for international research compliance is quick and non-punitive.
International research compliance: cost, efficiency and sustainability of the service
2 sessions · 8 pointsSession 1Where international research compliance typically breaks, and why
- Check that consent processes within international research compliance are genuinely informed.
- Distinguish symptoms from causes when international research compliance underperforms.
- Verify cold chain and storage conditions for materials used in international research compliance.
- Compare the cost of international research compliance with the cost of its absence.
Session 2The evidence assessors will ask for on international research compliance
- Name a single owner for each element of international research compliance.
- Review whether international research compliance is aligned with the objectives of the clinical service.
- Draft the minimum viable clinical protocol for international research compliance.
- Build the internal briefing that explains international research compliance to those affected.
International research compliance: supply, cold chain and availability
2 sessions · 8 pointsSession 1Auditing international research compliance at the bedside, not in the binder
- Rank the weaknesses in international research compliance by consequence rather than by ease of fixing.
- Confirm competence and continuing development for staff delivering international research compliance.
- Cost international research compliance per episode and identify avoidable waste.
- Build medication safety checks into international research compliance at the point of highest risk.
Session 2Keeping international research compliance alive after the initial push
- Define acceptance criteria for international research compliance in advance.
- Record what was learned when international research compliance did not go as planned.
- Confirm that contractual obligations around international research compliance are understood.
- Identify the data already collected that bears on international research compliance.
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
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