Note: Provisional timetable, the actual schedule may vary depending on the situation.
Programme Day 1
09.00 - 09.15 h Welcome/Introduction
09.15 - 09.45 h
A first Case Study
09.45 - 10.15 h
Interface between GMP and GCP
- Clinical trials Phase I – III, Investigator-Initiated Trials and Pre-Approval Access to IMPs
10.15 - 10.30 h Break
10.30 - 11.30 h
Legislation related to Investigational Medicinal Products (IMPs)
- Legislation impacting IMP QPs
- New & upcoming regulations and guidance
- Other topics – within and outside the EU
11.30 - 12.00 h
Q&A Session 1
12.00 - 13.00 h Break
13.00 - 14.00 h
Packaging and Labelling of IMPs
- Blinding aspects in packaging
- Packaging technology
- Unblinding risks during packaging
- Just-in-time labelling
- Relabeling
- Reconstitution
14.00 - 15.00 h
Distribution of IMP Supplies
- Distribution concept and prerequisites
- IRT
- Temperature controlled shipments
- Temperature deviations
- Site transfer
- Depots
- Customs
15.00 - 15.15 h Break
15.15 - 16.15 h
Challenges from a CTS coordinators perspective
- Supply Chain Planning
- Comparators: selection, procurement, pedigree
- Blinding
- NIMPs
- Shelf-life assignment
- Outsourcing
16.15 - 17.00 h
Q&A Session 2
Programme Day 2
09.00 - 10.00 h
GCP/GMP Inspections
- The inspection and monitoring process
- Typical and recurrent compliance issues
- Typical issues at the interfaces
- Inspections findings
10.00 - 10.45 h
The Role of the QP in Clinical Trials
- When does the QP responsibility end?
- Dealing with deviations during distribution
- How to handle deviations at investigator sites
- Extension of shelf-life
- Oversight of distribution and transport
- The responsibility for comparators
10.45 - 11.00 h Break
11.00 - 12.00 h
Case Study: QP tasks and challenges in Clinical Trials
12.00 - 12.45 h
Q&A Session 3
12.45 - 13.45 h Break
13.45 - 15.15 h
GCP Aspects to Consider for IMPs
- Roles and responsibilities: Sponsor, CRA, Investigator
- ICH GCP
- Storage of IMPs
- Reconstitution
- Accountability and Reconciliation
- Sponsor: Achieving and Maintaining the Blind
- IMP return and destruction
- IMP related documentation
15.15 - 15.30 h Break
15.30 - 16.30 h
Contracts and Agreements in the Management of Clinical Trials
- Applicable law and jurisdiction
- Contractual partners and QP participation
- Contract concepts
- Typical building blocks
16.30 - 17.00 h
Q&A Session 4
Programme Day 3
08.30 - 09.15 h
Data (and Study) Integrity in Clinical Trials
- Responsibilities of investigator, sponsor and monitor
- Vendors and contractors of electronic systems:
- Considerations and pitfalls
- Why do we need an Audit Trail (Review)?
- Inspection findings
09.15 - 10.15 h
Handling IMPs at a Hospital Pharmacy
- The role of the hospital pharmacy: manufacturing, organisation, consultancy
- The interface of manufacturing IMPs at a Hospital pharmacy and the daily work
- Investigator-Initiated Trials (IITs)
- FAQs: things you need to consider
- Challenges and problem solving
10.15 - 10.30 h Break
10.30 - 11.30 h
Case Study on GCP Aspects: Handling IMPs at the Investigator’s Site
11.30 - 12.00 h
A last Case Study: How things can go wrong
- How would you have reacted?
12.30 - 12.30 h
Q&A Session 5