GMP meets GCP - Management, Supply and Quality Assurance of Clinical Trials
Heidelberg, Germany
Course No 16588
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Speakers
Inge De Meyer, Janssen Pharmaceutica NV
Rita Hattemer-Apostel, Verdandi AG
Ian Holloway, GMP/GDP/GCP Inspector, MHRA (invited)
Andreas Jungk, Lawfirm Jungk
Dr Claudio Lorck, AbbVie
Dr Andreas Schwinn, Roche Pharma
Dr Lenka Taylor, University Hospital of Heidelberg
Objectives
During this course, well-experienced specialists will share their expert knowledge about important aspects of IMP Supplies and the Management of Clinical Trials. Hear essential aspects about the organisation and management of the supplies, their distribution, things to consider during the study and learn how the various regulations lead the way. During this event, the important interfaces between GMP and GCP will be elaborated.
Background
In the development of new pharmaceutical products, it is a challenge to design and initiate sound and appropriate studies. Compliance with GMP and GCP regulations is mandatory. A prerequisite for a successful study is the thorough planning of the clinical trial supplies. Beginning with the order, the manufacturing and supply of the IMPs, an efficient study management and full compliance with applicable rules and regulation will lead to satisfactory results. GMP and GCP requirements need to be considered and understood from all parties involved.
Trials outside the EU and contracts and agreements are two other aspects which require particular attention.
This event has been designed by the ECA to enhance and broaden your knowledge and to consolidate the various aspects which need to be taken into account for an efficient management of clinical trials.
Target Group
Specialists, managers and executives from R&D dealing with the various aspects of IMP supply and clinical trial management. It addresses representatives from IMP manufacturing, packaging, QP certification and supply as well as from the study design and management and the respective Quality Assurance units. It is also directed to CROs and members of inspectorates and authorities.
Programme
Case Studies
How things can go wrong
Interfaces between GMP and GCP
Clinical trials Phase I – III, Investigator-Initiated Trials and Pre-Approval Access to IMPs
CTS Planning
- Supply Chain Planning
- Comparators: selection, procurement, pedigree
- Blinding
- NIMPs
- Shelf-life assignment
- Outsourcing
- IRT: Pros and Cons to use for a particular study
- Blinding aspects in packaging
- Packaging technology
- Unblinding risks during packaging
- Just-in-time labelling
- Relabeling
- Reconstitution
- Challenges in the initiation and conduct of Compassionate Use: Single-patient, Multi-patient (cohorts)
- Who is responsible in regard of GMP?
- Who is responsible in regard of GCP?
- The inspection and monitoring process
- Typical and recurrent compliance issues (regarding IMPs)
- Typical issues at the interfaces
- Inspections in Europe and beyond
- Distribution concept and prerequisites
- IRT
- Temperature controlled shipments
- Temperature deviations
- Site transfer
- Depots
- Customs
- 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
- When does the QP responsibility end?
- Dealing with deviations during distribution
- How to handle deviations at investigator’s site
- Extension of shelf-life
- Oversight of distribution and transport
- The responsibility for comparators
Evaluate and discuss with the other delegates and the speakers case studies on:
- Study Planning: Challenges from a CTS coordinators perspective
- Case Studies: Open Discussion of QP Tasks and Challenges in Clinical Trials
- GCP Aspects: Handling IMPs at the Investigator’s Site
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
- Applicable law and jurisdiction
- Representations and warranties
- Indemnification and liability
- Frequently asked questions
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