Sprecher
Brigitte Bastyns, Johnson&Johnson
Rita Hattemer-Apostel, Verdandi AG
Andreas Jungk, Lawfirm Jungk
Helena Lindberg, GCP Inspector, Swedish Medical Products Agency
Dr Claudio Lorck, AbbVie
Dr Andreas Schwinn, Roche Pharma
Lenka Taylor, University Hospital of Heidelberg
Maria Wängelin, GDP/GMP Inspector, Swedish Medical Products Agency
Zielsetzung
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
Hintergrund
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.
Zielgruppe
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.
Programm
Case Studies
How things can go wrong
Interface between GMP and GCP
Examples of why GMP and GCP do have an impact on what happens during clinical trials
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
Packaging and Labelling of IMPs
Blinding aspects in packaging
Packaging technology
Unblinding risks during packaging
Just-in-time labelling
Relabeling
Reconstitution
QC Aspects
CMC Aspects of comparator modifications
Comparative dissolution, Stability, BE studies
Shelf-life Assignment for Comparators
Stability concepts for comparator studies
Shelf-life Assignment
Assessment of temperature deviations
Mean kinetic temperature
QC approach for site transfer
GCP and GMP Inspections
The inspection and monitoring process
Typical and recurrent compliance issues
Typical issues at the interfaces
Inspections in Europe and beyond
Distribution of IMP Supplies
Distribution concept and prerequisites
IRT
Temperature controlled shipments
Temperature deviations
Site transfer
Depots
Customs
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
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’s site
Extension of shelf-life
Oversight of distribution and transport
The responsibility for comparators
Three Workshops on Case Studies
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
You will be able to attend all 3 workshops.
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
International Contracts and Agreements in the Management of Clinical Trials
Applicable law and jurisdiction
Representations and warranties
Indemnification and liability
Frequently asked questions
A last Case Study - how things can go wrong
How would you have reacted?
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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