IMPACT-CGT- ISCT Joint Session: A Roadmap for Accelerating Access to Life-Saving Therapies in South and Central America Author: Maroun Khoury, PhD IMPACT, Center for Interventional Medicine for Precision and Advanced Cellular Therapy Chile Editor(s): Fernando E. Figueroa, MD,...
Author: Alejandro Barquero, MPharm, MSc DanausGT Biotechnology Ltd. Madrid, Spain Committee of Advance Therapy (CAT) Minutes of the meetings Minutes for the meeting on 14-16 February 2024 https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-14-16-february-2024 en...
Giulia Giunti, PhD 1 1 Regulatory Affairs Manager, BioOra Ltd, New Zealand AUSTRALIAN AND NEW ZEALAND REGULATORY UPDATES AOTEAROA – NEW ZEALAND In May 2024, the New Zealand Government published the 2024 Budget, which outlines the government’s goal and allocates spending and...
Alejandro Barquero, MPharm, MSc CMC Manager ISCT Legal and Regulatory Affairs Committee: Europe DanausGT Biotechnology Ltd. Madrid, Spain Laura Mendieta, PhD Senior Scientific and RA Officer Project Manager ISCT Legal and Regulatory Affairs Committee: Europe Asphalion ...
Co-Authors : Sita Somara, PhD RTI International Durham, NC United States Aisha Khan, PhD University of Miami Miami, FL United States The U.S. Food and Drug Administration (FDA) has recently authorized the State of Florida’s Agency for Health Care...
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 Co-Author: Martin Hernán Bonamino, PhD Instituto Nacional de Câncer Brazil Maroun Khoury, PhD IMPACT, Center for Interventional Medicine for Precision and Advanced Cellular Therapy Chile Editor: Fernando E. Figueroa, MD, FACP Universidad de los Andes School of Medicine Chile ...
by J. Kaitlin Morrison, PhD Executive Director Clinical Research, UNC Lineberger Comprehensive Cancer Center Assistant Professor of Medicine- Hematology, University of North Carolina- Chapel Hill Editor(s): Joseph Schwartz, MD, MPH Moffitt Cancer Center and Research Institute...