Plan continuity of clinical trial phase planning during surge, outbreak and emergency.
Planning the Phases of Clinical Trials
Develop the judgement and the documentation needed to run clinical trial phase planning properly.
📍 Cairo🗓️ 5 training days📚 4 modules🎓 Accredited certificate
5intensive training days
4scientific modules
8training sessions
32detailed points
Course Overview
The data supporting clinical trial phase planning is usually present but rarely assembled into a decision. Cost pressure and quality expectations on phase planning are rising at the same time. Participants come from operational and oversight roles, and both perspectives on this part of health and pharmaceutical services are used deliberately. Most organisations already have a policy on clinical trial phase planning; far fewer can show it working. Cases are chosen to expose the trade-offs in the health and pharmaceutical services discipline rather than to illustrate ideal conditions. The most reliable predictor of sound phase planning is whether anyone reviews it when nothing has gone wrong. The course leaves participants able to diagnose weaknesses in clinical trial phase planning before they become incidents. Participants leave with a method for phase planning, not a set of opinions about it. The course ends by identifying what the participant will stop doing to make this strand of health and pharmaceutical services sustainable.
Expected Learning Outcomes
Translate policy on phase planning into procedures that hold up under day-to-day pressure.
Apply regulatory and licensing requirements governing clinical trial phase planning.
Prepare the documented evidence accreditation assessors expect on phase planning.
Assess and control infection risk associated with clinical trial phase planning.
Agree the first three actions on phase planning that will be taken on returning to work.
Prepare a short, evidence-based briefing on clinical trial phase planning for senior management.
Who Should Attend
Risk managers assessing the exposure created by clinical trial phase planning.
Regulatory affairs specialists handling phase planning.
Supply chain and biomedical staff supporting clinical trial phase planning.
Newly appointed managers taking on phase planning for the first time.
Clinical department heads responsible for clinical trial phase planning.
Medical directors overseeing clinical governance of phase planning.
Course Modules
Clinical trial phase planning: incident reporting, investigation and learning
2 sessions · 8 pointsSession 1Keeping supply and cold chain reliable for clinical trial phase planning
- Reduce the variation in how clinical trial phase planning is carried out between teams.
- Build the internal briefing that explains phase planning to those affected.
- Establish who is informed, consulted and accountable in clinical trial phase planning.
- Set escalation thresholds for phase planning that work out of hours.
Session 2The decisions in phase planning that cannot be delegated
- Close the loop: confirm changes to clinical trial phase planning improved the indicator they targeted.
- Confirm patient data handled within phase planning meets confidentiality obligations.
- Measure patient experience of clinical trial phase planning and feed it back to the team.
- Agree the indicators that will show whether phase planning is improving.
Phase planning: regulation, licensing and accreditation evidence
2 sessions · 8 pointsSession 1Investigating an adverse event involving phase planning
- Check that records of clinical trial phase planning answer the questions likely to be asked.
- Decide what will be stopped to create capacity for phase planning.
- Set the review interval for clinical trial phase planning and who attends.
- Agree the smallest change to phase planning that would be visibly useful.
Session 2The evidence assessors will ask for on phase planning
- Apply structured root cause analysis to the last adverse event involving clinical trial phase planning.
- Collect evidence on the present handling of phase planning before proposing changes.
- Match staffing levels on clinical trial phase planning to measured demand across the week.
- Estimate the resource phase planning requires to run as designed.
Phase planning: clinical process design and workflow
2 sessions · 8 pointsSession 1Infection risk created by phase planning
- Draft the minimum viable clinical protocol for clinical trial phase planning.
- Confirm licensing and regulatory requirements applying to phase planning are met.
- Confirm competence and continuing development for staff delivering clinical trial phase planning.
- Cost phase planning per episode and identify avoidable waste.
Session 2Consent, confidentiality and ethics in clinical trial phase planning
- Identify single points of dependency in clinical trial phase planning and reduce them.
- Anticipate the objections phase planning will raise and prepare the answers.
- Verify cold chain and storage conditions for materials used in clinical trial phase planning.
- Assemble the accreditation evidence pack for phase planning.
Phase planning: cost, efficiency and sustainability of the service
2 sessions · 8 pointsSession 1Comparing phase planning with recognised practice
- Define escalation criteria for deterioration detected through clinical trial phase planning.
- Build medication safety checks into phase planning at the point of highest risk.
- Identify infection transmission risks created by clinical trial phase planning and control them.
- Select quality indicators for phase planning that measure outcome rather than activity.
Session 2Making phase planning work when resources are constrained
- Check that consent processes within clinical trial phase planning are genuinely informed.
- Map the clinical workflow for phase planning as it is actually performed.
- Map the handovers in clinical trial phase planning between functions and secure them.
- Close out actions on phase planning rather than leaving them open indefinitely.
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.