Regulatory Watchdog

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  • 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 ...

  • 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Guidances Released March 2022 Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products - Draft Guidance for Industry - LINK Human Gene Therapy Products Incorporating ...

  • 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 ...

  • 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), ...

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