Clinical Trials with Advanced Therapy Medicinal Products (ATMPs/ATIMPs) are by definition more complex and have additional regulatory requirements compared to other types of IMP. This course, which can in integrated into a general GCP Update or Refresher course, covers this additional complexity.
Who is it suitable for?
This course is suitable for anyone involved in planning or implementing clinical trials with ATIMPs, for example: Clinical Operations, Clinical Project Managers, CRAs, CTAs, Investigators, Research Nurses, Study Site Co-ordinators, R&D managers.
This course refers to EMA and FDA guidance and legislation on Advanced Therapy Medicinal Products and clinical trials.
To provide delegates with an understanding of:
- Specific legislation and guidance covering clinical trials with ATIMPs
- Recent and forthcoming changes in regulatory requirements
- Practical implications for clinical trials
Delivery of the course will consist of a combination of presentations by the trainer, group discussion and case studies. This course will also be supported by additional resources available from our website.
This course can be run as a stand alone course or webinar in around half a day, or incorporated into a full day GCP Update or Refresher course.
What is an ATIMP – definitions and categories
First In Human Trials
- EMA guidance on first in human trials
- Dose selection and escalation
- GCP considerations
GCP for ATIMPs
- Clinical Trial Design
- GMP for ATIMPs
- Safe conduct of the trial
- Interventions and administration of product
- Informed Consent
- Safety Reporting
- Record keeping and archiving
Long Term Follow up
- EMA and FDA expectations and requirements
- Design and duration of Long Term Follow Up
- Implementation of Long Term Follow Up
- Remote follow up
Please contact me for more information and to organise your course.
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