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 ...
Alejandro Barquero, MPharm, MSc ISCT Legal and Regulatory Affairs Committee: Europe DanausGT Biotech Ltd. Spain Hind Al Belushi, PhD ISCT Legal and Regulatory Affairs Committee: Europe Royal Hospital ...
FDA Approves First Gene Therapy to Treat Adults with Hemophilia B: Most Expansive Drug in the World Aisha Khan, PhD Legal and Regulatory Affairs Committee: North America University of Miami ...
The Challenge of Unregulated Regenerative Medicine – A Latin American Perspective by M. Ignacia Cádiz, MsC Fernando Figueroa, MD Universidad de los Andes Santiago, Chile Over the past decades, ...
by Gabrielle O’Sullivan PhD MPH 1 1 Executive Officer Royal Prince Alfred Hospital Institutional Biosafety Committee Royal Prince Alfred Hospital Australia Giulia Giunti PhD 2 2 Quality ...
North America Legal and Regulatory Affairs Watchdog Update October 2022 By Guest Contributor: Mackenna Roberts, MA Choice Telemed London, United Kingdom Co-Editors: Crystal ...
Australia and New Zealand Legal and Regulatory Affairs Watchdog Update October 2022 By: Gabrielle O’Sullivan PhD MPH 1 and Giulia Giunti PhD 2 1 Executive Officer, Royal Prince ...
Europe Legal and Regulatory Affairs Watchdog Update October 2022 Hind Al Belushi, PhD ISCT Legal and Regulatory Affairs Committee: Europe Royal Hospital Sultanate of Oman Committee ...
Information for Practitioners- FDA’s Regulatory Oversight of Regenerative Medicine Products Webinar The FDA’s Center for Biologics Evaluation and Research (CBER) is hosting a public webinar on ...
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: ...
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 ...
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 ...
ISCT Preparing to Submit Comments on Consultations from ICH, European Commission, and FDA The ISCT Global Regulatory Committees and Lab Practices Committees will be responding to the following ...
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 ...
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 ...
Australia and New Zealand Legal and Regulatory Affairs Watchdog Update June 2022 By: Gabrielle O’Sullivan PhD MPH Executive Officer, Royal Prince Alfred Hospital Institutional ...
The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT) launches new webpage, Interactions with Office of Tissues and Advanced Therapies | FDA ...
ICH Consultations Open Until July and August 2022 ISCT Global Regulatory Committees and the Lab Practices Committee will be responding to these ICH Draft Guidances: ICH Q2(R2) Validation of ...
Europe Legal and Regulatory Affairs Watchdog Update April 2022 By: Hind Al Belushi, PhD ISCT Legal and Regulatory Affairs Committee: Europe Royal Hospital Sultanate of Oman Committee ...
Australia and New Zealand Legal and Regulatory Affairs Watchdog Update April 2022 By: Gabrielle O’Sullivan PhD MPH Executive Officer, Royal Prince Alfred Hospital Institutional ...
North America Legal and Regulatory Affairs Watchdog Update April 2022 By: Sowmya Viswanathan, PhD University Health Network and University of Toronto, Toronto CANADA Health Canada ...
NEW - ISCT South & Central America (SCA) Legal & Regulatory Affairs (LRA) Comittee ISCT SCA LRA The South & Central America Regional Executive Committee are pleased to announce the launch ...
FDA Draft Guidances Released March 2022 Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products - Draft Guidance for Industry - LINK Human Gene Therapy Products Incorporating ...
ISCT Responds to TGA Consultation on Priority Review pathway for biologicals: feasibility, potential eligibility criteria and determination process Closed March 28, 2022 ISCT Regulatory Committees ...
North America Legal and Regulatory Affairs Watchdog Update February 2022 By: Mo Heidaran, PhD Head of Translational and Regulatory Strategy, GC Therapeutics Joseph (Yossi) Schwartz, ...
Europe Legal and Regulatory Affairs Watchdog Update February 2022 By: Hind Al Belushi, PhD ISCT Legal and Regulatory Affairs Committee: Europe Royal Hospital Sultanate of Oman Committee ...
Australia and New Zealand Legal and Regulatory Affairs Watchdog Update February 2022 By: Gabrielle O’Sullivan PhD MPH Executive Officer, Royal Prince Alfred Hospital Institutional ...
ISCT Supports Therapeutic Goods Administration (TGA) Adoption of certain international scientific guidelines in Australia Closed February 20, 2022 ISCT Regulatory Committees (ANZ LRA, EU LRA, ...
ISCT provided comments for WHO Considerations on Regulatory Convergence of Cell and Gene Therapy Products Closed 24 January 2022 ISCT Regulatory Committees (ANZ LRA, EU LRA, NA LRA, SCA LRA, GRTF), ...