|? CAR T cells – the new aspirin? Cell based therapies have been offered as IMPs for many years. It is only quite recently that such therapies have been approved for commercial use.|
? FDA released a summary of HCT/P inspectional findings from 2014 – 2018
? In 2018 alone, FDA released SIX new guidances on gene therapy
? Several warning letters have been issued to institutions manufacturing cell based products and gene therapy products
? Many guidances have been released
q Brainstorm risks associated with ATMPs/ HCT/Ps
q Viral vectors vs live bacteria vs minimal manipulation – can they share a facility?
q Warning letters: “for research use only” reagents; EM programs; manual operations
q EU ATMP GMPs – a review and comparison with Annex 1
q FDA HCT/P guidance and how to stay up to date
q Cell based QC assays, reproducibility, OOS, OOT and deviations handling
q USP Chapters for Cell Gene and Tissue Based Products
? <1043> Ancillary Materials [e.g. “for research use only”]
? <1046> Cellular and Tissue Based Products
? <1047> Gene Therapy Products
q FDA guidance for cellular and gene therapy products
q EMA guidances for ATMPs
q Outsourcing, CDMOs and working with hospital based facilities
q Other resources
Objective: Become familiar with the regulations and guidance for cell, tissue and gene therapies and learn what resources are available to manage this rapidly developing area of therapeutics. Over the past 10 years, this area of drug products has produced more therapies for unmet need than classical pharmaceuticals and it would seem this is the future.
Benefits Participants will become familiar with the risks specifically associated with the production, handling and supply of ATMP products; learn about the available resources, the GMP guidance and have an opportunity to benchmark best practices.
This course is suitable for:
Anyone developing, manufacturing, overseeing the manufacture of and QPs releasing ATMPs/ HCT/Ps. Anyone involved in clinical trials, regulatory affairs and registration of INDs, IMPDs for these types of products will also find the course useful.
This course will be presented Karen Ginsbury, of PCI Pharmaceutical Consulting Israel. Karen has over 30 years’ experience of quality systems in the pharmaceutical industry. Karen has several clients with ATMP products and has successfully navigated them through complex and in-depth regulatory inspections. Come and hear some of the issues that are troubling the inspectors about the facilities and institutions manufacturing or offering contract manufacture services for ATMPs
As a past member of PDA’s Regulatory Affairs and Quality Advisory Board, Karen Ginsbury was and remains actively involved in commenting groups on EU, US and worldwide changes to GMPs and guidances as well as interpretation.
|24-09-2019 kl.:09.00 til kl.:16.00|
Symbion, Fruebjergvej 3, 2100 København Ø
Der vil være morgenmad fra kl. 8.30
|Max antal deltagere: 70, der er 67 pladser tilbage|