GMP meets GCP - Live Online Training

GMP meets GCP - Live Online Training

Course No 19179

This course is part of the GMP Certification Programme "ECA Certified Pharmaceutical Development Manager". Learn more.

Note: All times mentioned are CEST.

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Speakers

Sandra Blim, AbbVie
Dr Gundula Born, Sanofi-Aventis
Inge De Meyer, Janssen
Silja du Mont, GCP/GDP Inspector
Rita Hattemer-Apostel, Verdandi
Patryk Jegorow, Takeda
Dr Lenka Taylor, University Hospital of Heidelberg

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 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. Especially, in regard of trials performed in UK after the Brexit.
 
On 31 January 2022, the Clinical Trials Regulation 536/2014 (CTR) will become applicable. This will be followed by a consecutive transition period of three years, during which both the Contents of the CTR and the current legislation on clinical trials will apply.

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 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.

Technical Requirements

For our Live Online Training Courses/Conferences, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Note: Provisional timetable, the actual schedule may vary depending on the situation.
 
Programme Day 1
 
09.00 - 09.15 h Welcome/Introduction
 
09.15 - 09.45 h
A first Case Study
  • How things can go wrong
09.45 - 10.15 h
Interface between GMP and GCP
  • Clinical trials Phase I – III, Investigator-Initiated Trials and Pre-Approval Access to IMPs
10.15 - 10.30 h Break
 
10.30 - 11.30 h
Legislation related to Investigational Medicinal Products (IMPs)
  • Legislation impacting IMP QPs
  • New & upcoming regulations and guidance
  • Other topics – within and outside the EU
11.30 - 12.00 h
Q&A Session 1
 
12.00 - 13.00 h Break
 
13.00 - 14.00 h
Packaging and Labelling of IMPs
  • Blinding aspects in packaging
  • Packaging technology
  • Unblinding risks during packaging
  • Just-in-time labelling
  • Relabeling
  • Reconstitution
14.00 - 15.00 h
Distribution of IMP Supplies
  • Distribution concept and prerequisites
  • IRT
  • Temperature controlled shipments
  • Temperature deviations
  • Site transfer
  • Depots
  • Customs
15.00 - 15.15 h Break
 
15.15 - 16.15 h
Challenges from a CTS coordinators perspective
  • Supply Chain Planning
  • Comparators: selection, procurement, pedigree
  • Blinding
  • NIMPs
  • Shelf-life assignment
  • Outsourcing
16.15 - 17.00 h
Q&A Session 2
 
 
Programme Day 2
 
09.00 - 10.00 h
GCP/GMP Inspections
  • The inspection and monitoring process
  • Typical and recurrent compliance issues
  • Typical issues at the interfaces
  • Inspections findings
10.00 - 10.45 h
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
10.45 - 11.00 h Break
 
11.00 - 12.00 h
Case Study: QP tasks and challenges in Clinical Trials
 
12.00 - 12.45 h
Q&A Session 3
 
12.45 - 13.45 h Break
 
13.45 - 15.15 h
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
15.15 - 15.30 h Break
 
15.30 - 16.30 h
Contracts and Agreements in the Management of Clinical Trials
  • Applicable law and jurisdiction
  • Contractual partners and QP participation
  • Contract concepts
  • Typical building blocks
16.30 - 17.00 h
Q&A Session 4
 
 
Programme Day 3
 
08.30 - 09.15 h
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
09.15 - 10.15 h
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
10.15 - 10.30 h Break
 
10.30 - 11.30 h
Case Study on GCP Aspects: Handling IMPs at the Investigator’s Site
 
11.30 - 12.00 h
A last Case Study: How things can go wrong
- How would you have reacted?
 
12.30 - 12.30 h
Q&A Session 5

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