The accreditors of this session require that you periodically check in to verify that you are still attentive.
Please click the button below to indicate that you are.
ICH Q9(R1) – Quality Risk Management (QRM) is currently being revised, and step 2 is expected to be reached by end of 2021. The update of this guideline is anticipated to benefit ATMP by fostering increased use of science based QRM activities. Advanced therapy medicinal products (ATMPs) are medicines that include a wide range of different products. Due to their complexity, the approaches used in the development, manufacture and control of well characterised biological products may not be fully applicable. A pro-active risk-based approach is essential to drive the product development and determine the extent of quality, non-clinical and clinical data required. This session will provide an update on ICH Q9 development and discuss the importance of Risk based approaches and QRM in the development of ATMP.
The EU Medical Device Regulation (MDR), which came into full effect in May 2021, has brought in new requirements for drug delivery devices often used for biologic products…
Efforts are underway to update and expand the applicability of ICH Q2(R1), Validation of Analytical Procedures, the authoritative guidance on analytical method validation…