Further Information

Further Information

Further in-depth reading on the classifications of ATMP/GM can be found in Directive 2001/83/EC, Annex I, Part IV and Regulation (EC) 1394/2007, Article 2 1(b).

GMO guidance:

HSE guidance is accessed here: https://www.hse.gov.uk/biosafety/gmo/index.htm.

Guidance from the Scientific Advisory Committee on Genetic Modification is accessed here: The SACGM Compendium of guidance (hse.gov.uk) (Part 6 refers to the use of GMOs in a clinical setting)

Advanced Therapies:

General ATMP education and training resources are available on the ATTC Network Advanced Therapies NHS Readiness Toolkit: https://www.theattcnetwork.co.uk/toolkit_section/education-and-training-resources

Clinical trials:

European Commissions: Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Product https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-10/atmp_guidelines_en.pdf

European Medicines Agency: Guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products