GMP meets GCP - Live Online Training

27-29 February 2024

Seminar-Nr. 21005


Patryk Jegorow

Patryk Jegorow


Ian Holloway

Ian Holloway

former GMP/GCP/GDP Inspector at MHRA

Note: All times mentioned are CEST.


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.


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.
Since 31 January 2022, the Clinical Trials Regulation 536/2014 (CTR) is applicable. This is followed by a consecutive Transition period of three years, during which both the contents of the CTR and the previous legislation on clinical trials will apply. Trials outside the EU and contracts and agreements are two other aspects which require particular attention. Especially, in regard of trials performed in UK after the Brexit.
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.


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.

Technical Requirements

We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/onlinetraining-technical-information you will find all the Information you need to participate in our trainings 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.


GMP meets GCP - Live Online Training

Gesamtes Programm als PDF herunterladen

Programme Day 1
A first Case Study
  • How things can go wrong
Interface between GMP and GCP
  • Clinical trials Phase I – III, Investigator-Initiated Trials and Pre-Approval Access to IMPs
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 from a CTS coordinators perspective
  • Supply Chain Planning
  • Comparators: selection, procurement, pedigree
  • Blinding
  • NIMPs
  • Shelf-life assignment
  • Outsourcing
Q&A Session 2
Programme Day 2
GCP/GMP Inspections
  • The inspection and monitoring process
  • Typical and recurrent compliance issues (regarding IMPs)
  • Typical issues at the interfaces
  • Inspections in Europe and beyond
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
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
  • Storage of IMPs
  • Reconstitution
  • Accountability and Reconciliation
  • Sponsor: Achieving and Maintaining the Blind
  • IMP return and destruction
  • IMP related documentation
Contracts and Agreements in the Management of Clinical Trials
  • Applicable law and jurisdiction
  • Contractual partners and QP participation
  • Contract concepts
  • Typical building blocks
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?
Q&A Session 5

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Teilnehmerstimmen - das sagen andere über unsere Seminare:

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023


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