Good clinical practice for ATMPs

1 Day/s

CPD Hours: 7

Online, in-house

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.

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

    By the end of the course, you will have learned :

    • Special legislation and guidance relating to the conduct of clinical trials with ATIMPs
    • Specific regulatory requirements
    • Pragmatic implications for clinical trials

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Meet the tutors

Amer Alghabban

"Amer Alghabban, a clinical pharmacologist by training, is a senior executive with over 30 years’ experience within pre-& clinical R&D, pharmacovigilance and GxP (GLP, GCP, GCLP, GMP & GVP) QA. Invited speaker at over 130 conferences, the author of The Pharmaceutical Medicine Dictionary, The Dictionary of Pharmacovigilance, and others. Previous positions; VP QA Compliance & Training at Karyopharm, Global Head QA at Merck Serono, Global Head GxP QA at Arpida, Clinical QA Manager at Novartis, and first Pharmacovigilance Compliance Officer of the MHRA, Assistant Editor for 11 medical journals and Course Director-RQA Pharmacovigilance Auditing Course."

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