Good Clinical Practice for ATMPs

This interactive course provides an advanced, practical detailed interactive review of the organizational fundamentals of Good Clinical Practice (GCP) specific to ATMPs. This course also covers the EMA’s and FDA’s requirements for the conduct of clinical trials with Advanced Therapy Medicinal Products.

During this interactive workshop, we will discuss in what way clinical research team members can apply and comply with the expected requirements of GCP specific to ATMPs. Specific attention will be given to how quality systems effect overall data integrity, patient clinical risk and respective regulatory risk for clinical trials conducted on ATMPs.

ATMPs are complex and inventive products that may pose specific challenges to the design and conduct of clinical trials. The challenges stem from various aspects of ATMPs such as (but not limited to) :

• Manufacturing constraints and the short shelf-life of the product may necessitate the application of rigid controls on logistical procedures to administer the product.
• Likewise, the mode of application may render very difficult the use of placebo controls and/or may require specific training.
• Furthermore, the long-term effects of the product may involve specific arrangements for long-term follow-up of trial subjects.
• Additionally, it is acknowledged that it may not always be feasible to generate related non-clinical data before the product is tested in humans.

Albeit the broad tenets of GCP set out in ICH Guidelines are applicable to clinical trials with ATMPs, in some cases, it may be necessary to adapt those to the specific characteristics of ATMPs (e.g. regarding retention of samples). The application of extra procedures may also be needed (e.g. traceability requirements for ATMPs that contain cells or tissues of human origin, follow-up of patients after end of the clinical trial, training on upstream intervention of subjects and/or administration procedures).

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This course is recommended for all organisations and professionals, Clinical Research Organizations (CROs), and academic Institutions conducting clinical trials on ATMPs. Professionals who wish to consolidate their learning to date with experiences gained from experts, advance their practical knowledge in this area. Including professionals from pharmaceutical, biotech, and medical device companies as well as CROs and eTMF/TMF service providers having or seeking responsibilities in the following areas, w.r.t planning and conduct of clinical trials with ATMPs, for example; Clinical Operations, Clinical Project Managers, CRAs, CTAs, Investigators, Research Nurses, Study Site Coordinators and managers.

This covers the following topics :

• Clinical Trial Design
• Non-clinical studies
• Quality of the investigational ATMPs
  • General considerations
  • Tissues and cells of human origin
  • Medical devices
  • Reconstitution
• Safe conduct of the clinical trial
• Information on the product
• Handling of the investigational ATMP
• Risk-minimisation measures
• Upstream interventions on subjects and administration procedures
  • Upstream interventions on subjects
  • Administration procedures
• Traceability
• Retention of samples
• Protection of clinical trial subjects
  • Informed consent
  • Long-term follow-up
  • Administration of out of specification products
• Safety Reporting
• Monitoring