GMP meets GCP - Management, Supply and Quality Assurance of Clinical Trials

GMP meets GCP - Management, Supply and Quality Assurance of Clinical Trials

Berlin, Germany

Course No 15625


Costs

Non-ECA Members: EUR 1990,--
ECA Members: EUR 1790,--
EU GMP Inspectorates: EUR 995,--
APIC Members (does not include ECA membership): EUR 1890,--
QP Association Members: EUR 1790,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Brigitte Bastyns, Johnson&Johnson

Rita Hattemer-Apostel, Verdandi AG

Andreas Jungk, Lawfirm Jungk

Dr Anne Lewerenz, GMP/GDP/GCP Inspector, Local Authorities Leipzig, Germany

Dr Claudio Lorck, AbbVie

Dr Andreas Schwinn, Roche Pharma

Dr Lenka Taylor, University Hospital of Heidelberg

Objectives

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.

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.

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.

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.

Programme

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
Clinical Trials with Advanced Therapy Investigational Medicinal Products (ATIMPs): GMP-GCP- Interface Management
  • ATIMPs: Examples and Definitions
  • Legal Requirements and Specifics for ATIMPs
  • Traceability: Responsibilities of Manufacturer and Sponsor
  • Adverse Events: Responsibilities of Manufacturer and Sponsor
  • Inspection Findings
Distribution of IMP Supplies
    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
    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?
    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.

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