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...
by Laura Mendieta, PhD ISCT Legal and Regulatory Affairs Committee: Europe Asphalion Spain Alejandro Barquero, MPharm, MSc ISCT Legal and Regulatory Affairs Committee: Europe DanausGT Biotech Ltd. Spain . Committee of Advance Therapy (CAT) Minutes of the meetings ...
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...
by Author: Darshan Patel, MS Fred Hutch Cancer Center United States Editor(s): Joseph Schwartz, MD, MPH Moffitt Cancer Center and Research Institute United States Crystal Ruff, PhD, MBA Takeda United Kingdom FDA CDER’s...