by Fajar Dumadi, BSc Regulatory Program Specialist ISCT Head Office This draft guidance provides recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy (CGT) product. This draft guidance document, when finalized...
On December 8, 2023, ISCT successfully hosted the landmark 20th FDA Cell Therapy Liaison Meeting (CTLM), a closed gathering strategically designed to facilitate discussions between the cell and gene therapy (CGT) community and the FDA. The primary goal of the CTLM is to address specific concerns...
Fajar Dumadi, BSc Regulatory Program Specialist ISCT Head Office . The second biannual Cell and Gene Therapy Global Regulatory Report from ISCT and Citeline will be released soon. Following the successful release of the inaugural report in June 2023, ISCT is delighted to...
Gabrielle O’Sullivan PhD MPH (Hons) Executive Officer, Royal Prince Alfred Hospital Institutional Biosafety Committee, Royal Prince Alfred Hospital, Australia . AUSTRALIAN AND NEW ZEALAND REGULATORY UPDATES Australian Government response to the House of Representatives...
Laura Mendieta, PhD - Senior Scientific and RA Officer Project Manager ISCT Legal and Regulatory Affairs Committee: Europe Asphalion Barcelona, Spain Alejandro Barquero, MPharm, MSc - CMC Manager ISCT Legal and Regulatory Affairs Committee: Europe DanausGT Biotechnology...
Aisha Khan, PhD University of Miami United States The Clinical Trials Transformation Initiative (CTTI), in collaboration with the U.S. Food and Drug Administration (FDA), presents this report. It focuses on the critical role of ClinicalTrials.gov as a primary information source...
by Fajar Dumadi, BSc Regulatory Program Specialist ISCT Head Office ISCT hosted the 20th FDA CTLM on December 8, 2023 with over 45 participants, comprised of representatives from AABB, ASFA, ASTCT, CAP, CBA, FACT, FDA/CBER/OTP/OCTHT/OGT/OCBQ/OCOD, ISCT, NHLBI, NMDP, SITC, USP, WMDA. ...
by Gabrielle O’Sullivan PhD MPH (Hons) 1 1Executive Officer, Royal Prince Alfred Hospital Institutional Biosafety Committee, Royal Prince Alfred Hospital, Australia . AUSTRALIAN AND NEW ZEALAND REGULATORY UPDATES Medsafe Medsafe has updated its Guidelines on the Regulation of...
Summary of Session 5 : Regulatory Updates 17 August 2023 Gabrielle O’Sullivan and Craig Wright, Session Co-Chairs Royal Prince Alfred Hospital, Sydney TGA Presentation: Regulation of cell and tissue therapies, an update Dr Glenn Smith, Director Biological Science Section,...
Ashley Krull, Ph.D. Associate Director, Cell Therapy Manufacturing and Engineering James Cancer Hospital Cellular Therapy Laboratory Assistant Professor, Hematology The Ohio State University Columbus, Ohio, United States On March 14th, 2023, the FDA held an engaging virtual...