Patryk Jegorow
Takeda
Referent:innen
Mag. Gabriela Schallmeiner
Inspection Ready Consulting, Austrian Qualified Person Association (aqpa)
Dr Alexander Bachmann
ATB Pharma Innovation
Dr. Thomas Becker
Dr. Thomas Becker Pharma & Biotech Consulting
Dr Lenka Taylor
University Hospital of Heidelberg
Ian Holloway
former GMP/GCP/GDP Inspector at MHRA
Gerlinde Schmitter
CureVac
Note: All times mentioned are CET.
Zielsetzung
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.
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 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.
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.
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.
Programm
Gesamtes Programm als PDF herunterladen
Programme Day 1
How Things can go wrong prior to IMP Application
- Deviation of transport and storage conditions
- Labelling issues
- Comparator sourcing
Interface between GMP and GCP
- Clinical Trial Ph I – III
- Interaction and Communication between sponsor and manufacturer / QP
- Investigator initiated Trials
- Early access program
- Compassionate use
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
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
GCP/GMP Inspections
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
- 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
GMP-related Quality Technical Agreements
- Legislation
- Contractual partners and QP participation
- Planning/ Concepts
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
| ECA-Member*: | € 2090,- |
| Non ECA Member*: | € 2290,- |
| EU/GMP Inspectorates*: | € 1145,- |
| APIC Member Discount*: | € 2190,- |
| QP Member Discount*: | € 2090,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Pharmaceutical Development Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Seminarprogramm als PDF
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