Management, Supply and Quality Assurance of Clinical Trials
16-18 June 2026
Course No. 22303
Note: All times mentioned are CEST.
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.
Objectives
During this Live Online Training 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 regulations will lead to satisfactory results. GMP and GCP requirements need to be considered and understood from all parties involved.
This Live Online Training Course has been designed by the ECA to enhance and broaden your knowledge and to consolidate the various aspects which need to be considered for an efficient management of clinical trials.
Programme
Introduction to Revision 3 of ICH E6 GCP
Completely revised structure
Applicable to various trial designs and technology-friendly
Clarified roles and responsibilities of sponsors and Investigators
Enhanced Data Governance requirements
Legislation Related to Investigational Medicinal Products (IMPs)
Legislation impacting IMP QPs
New & upcoming regulations and guidance
Other topics – within and outside the EU
Q&A Session 1
Packaging and Labelling of IMPs
Blinding aspects in packaging
Packaging Technology
Unblinding risks during packaging
Just-in-time labelling
Relabeling
Reconstitution
Distribution of IMP Supplies
Distribution concept and prerequisites
IRT
Temperature controlled shipments
Temperature deviations
Site Transfer
Depots
Customs
Challenges of Clinical Trial Material Supply
Supply Chain planning
Comparators: selection, procurement, Pedigree
Blinding
NIMPs
Shelf-life assignment
Outsourcing
Q&A Session 2
Programme Day 2
Interface between GMP and GCP
Clinical Trial Ph I – III
Interaction and communication between sponsor and manufacturer / QP
Investigator Initiated Trials
Early access programme
Compassionate use
The Role of the QP in Clinical Trials
QP Declaration (QPD)
QP Obligations derived from the “new Annex 13” (C(2017) 8179 final)/ Annex 16, Annex 21 and Clinical Trials Regulation (EU) No 536/2014
Differences between ATMPs and non-ATMPs
Case Study: QP Tasks and Challenges in Clinical Trials
Q&A Session 3
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
Risk-Based, Proportionate Quality Management in Clinical Trials
Aligning Risk Based Quality Management (RBQM) and QbD from trial design to reporting
Continuous, dynamic risk Management
Risk-proportionate, tailored oversight across the trial LifeCycle
Extend RBQM beyond investigator sites to central facilities, and service providers
Effective sponsor oversight and cross-functional collaboration
Q&A Session 4
Programme Day 3
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
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
Case Study on GCP Aspects: Handling IMPs at the Investigator’s Site
A last Case Study: How Things can go wrong
How would you have reacted?
Further Information
Technical Requirements We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate plus VAT) ECA Members € 1,890 APIC Members € 1,990 Non-ECA Members € 2,090 EU GMP Inspectorates € 1,045 The fee is payable in advance after receipt of invoice.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Testimonials
