Whitepaper
21 Mar 2023

EU Clinical Trial Regulation 2022_ Understanding the impact on clinical research in Europe

PDF 4.5 MB

Eight years after its adoption, the EU Clinical Trial Regulation (CTR) 2022 has come into full application, radically altering the regulatory landscape for conducting clinical trials in EU member states and European Economic Area (EEA) countries. This whitepaper provides insight into the key changes introduced by the regulation and guidance for managing anticipated challenges, focusing specifically on the following considerations:

The impact of the new regulation on existing clinical trialsThe implications for good manufacturing practice (GMP) guidance and the Clinical Trial Application (CTA) processNew labelling requirements, the challenges they may pose, and potential solutionsThe UK’s approach to clinical trial regulation and the impact of the EU CTR changes on Qualified Person (QP) requirements and other legislation

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Thermo Fisher Scientific Inc.

  • US
  • 2015
    On CPHI since
  • 2
    Certificates
  • 5000+
    Employees
Company types
CMO/CDMO
Contract Research Organisation (CRO)
Manufacturer/Innovator
Primary activities
Clinical Research
Contract Manufacturer
Contract Research Organisation
Packaging & drug delivery
Supply Chain

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    Getting biological drug products to first-in-human (FIH) trials requires a deep and nuanced understanding of the scientific and regulatory challenges unique to these complex large molecule substances. Prioritizing regulatory CMC guidance and careful preparation of quality dossiers is integral to success from the very early stages throughout clinical development. This report identifies key strategies for developing a carefully executed, robust CMC dossier and avoiding common deficiencies that lead to clinical holds.
  • Whitepaper Switching delivery formats for sterile injectables

    Switching delivery formats can be an effective strategy to enhance they lifecycle of your drug. This whitepaper provides insight into the benefits and challenges of transferring a therapeutic compound from one aseptic injectable format to another, focusing specifically on the following:

    The material and process information and data needed to inform decision-makingTh...
  • Technical Data Four special fill/finish considerations for vaccine production

    Once your vaccine is ready for production, there are critical considerations needed in regard to the handling and process for fill/finish. The right choices can help ensure the stability and purity of your vaccine as well as limit unnecessary waste and cost. View the infographic for details on best practices for fill/finish.
  • Video The Road to Quality: Eliminating Supply Chain Blind Spots

    Managing the biopharma supply chain is a highly complex undertaking that is becoming ever more so as the number of new products rises and new process technologies are introduced. Moving with ease from one step to the next (R&D, production, distribution) while adhering to regulations and meeting customer demands involves managing many moving parts. It also requires managing a growing number of channels through which data needs to be sent, received, and tracked. Awareness and oversight over every activity and relationship along the continuum is critical for avoiding disruptions that can negatively influence distribution processes This presentation will provide insight into some of common blind spots that threaten supply chain quality, including: Supply chain vulnerabilities Insufficient demand signals Under-nurtured supplier relationships Supply chain network customization Attendees will learn about the measures that should be embedded throughout the supply chain, from procurement through last-mile delivery, to avoid these blind spots and build customer trust and confidence
  • Whitepaper Evolving solutions to optimize clinical trial decentralization

    The benefits offered by decentralized trials are driving wider adoption of this approach to clinical research. The introduction of novel solutions to facilitate adherence can support decentralized trials and mitigate potential concerns surrounding reduced patient-physician touchpoints.

    This whitepaper highlights Thermo Fisher's solutions to drive high adherence in decentralized trials.

  • Technical Data Cold chain services for clinical trial success

    This interactive infographic highlights Patheon’s capabilities for maintaining cold chain integrity across the supply chain. Utilizing our global network and expertise, our end-to-end cold chain management services can support your advanced clinical trial needs with:
    Cold chain storage and distributionGlobal CryoHubsSecondary packaging and labelingKit productionLaboratory services
  • Technical Data Interactive Clinical Trial Services Infographic

    This interactive infographic provides a summary of Patheon's end-to-end clinical trial service capabilities. You can click on any service line pod and it will dynamically display information related to that service line. This is inclusive of clinical supply planning and project optimization, clinical ancillary supplies sourcing and management, comparator and co-medication sourcing, cold and ultracold clinical supply chain management, global clinical packaging and labeling, storage, distribution, and clinical logistics management, and decentralized trial capabilities.
  • Whitepaper Prepping for commercialization through supply chain logistics

    With the rapid expansion of the cell and gene therapy market, innovators will require reliable supply chain solutions to enable the sage and efficient transportation of products to patients in need. 
    The following article highlights several industry challenges and key considerations as clients prepare for commercialization of advanced therapy products including:
    Ultra-low temperature controlManagement of stringent timelinesDocumentation and tracking requirementsScale-up capabilitiesCommunication strategy