Sita Somara, PhD, MBA RTI International United States FDA has recently shared the news that it is taking steps to help gene therapies get accelerated approval. According to Dr. Marks, the director of FDA's Center for Biologics Evaluation and Research, "the FDA views gene...
Updates and regulatory news Health Canada What’s new in Biologics, radiopharmaceuticals and genetic therapies can be found at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radio-pharmaceuticals-genetic-therapies/what-new-biologics...
Alejandro Barquero, MPharm, MSc ISCT Legal and Regulatory Affairs Committee: Europe DanausGT Biotech Ltd. Spain Laura Mendieta, PhD ISCT Legal and Regulatory Affairs Committee: Europe Asphalion Spain Committee of Advance Therapy (CAT) Committee for Advanced Therapies (CAT): Work...
Gabrielle O’Sullivan PhD MPH 1 and Giulia Giunti PhD 2 1 Executive Officer, Royal Prince Alfred Hospital Institutional Biosafety Committee, Royal Prince Alfred Hospital, Australia 2 Quality Manager, M alaghan Institute of Medical Research, Wellington, New Zealand ...
by Fajar Dumadi, BSc Regulatory Program Specialist ISCT Head Office . The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) hosted a virtual town hall to answer stakeholder questions related to the clinical development of...
North America Legal and Regulatory Affairs Watchdog Update August 2022 Kevin Bosse, PhD, RAC Elizabeth George, MS Nationwide Children's Hospital Columbus, OH, United States Co-Editors: Yossi Schwartz MD, MPH Mount Sinai Health System New York NY, United States Crystal Ruff...
Europe Legal and Regulatory Affairs Watchdog Update August 2022 By: Hind Al Belushi, PhD Royal Hospital Sultanate of Oman Committee of Advance Therapy (CAT) 1. Minutes of the meetings a. Minutes of the meeting (15-17 June 2022) https://www.ema.europa.eu/en/documents...
Australia and New Zealand Legal and Regulatory Affairs Watchdog Update August 2022 By: Gabrielle O’Sullivan PhD MPH Executive Officer, Royal Prince Alfred Hospital Institutional Biosafety Committee, Royal Prince Alfred Hospital Australia Giulia Giunti PhD ...
North America Legal and Regulatory Affairs Watchdog Update June 2022 By: Kaitlin Morrison, PhD Director of UNC Lineberger Sponsored Clinical Research, UNC Lineberger Comprehensive Cancer Center Assistant Professor of Medicine- Hematology, University of North Carolina- Chapel...
Europe Legal and Regulatory Affairs Watchdog Update June 2022 By: Hind Al Belushi, PhD ISCT Legal and Regulatory Affairs Committee: Europe Royal Hospital Sultanate of Oman Committee for Advanced Therapies (CAT) CAT is the European Medicines Agency's (EMA)...