Write-up on a Roundtable Session: “Regulating MSC Clinics: Are we doing enough to protect patients” at the ISCT 2023 Annual Meeting in Paris Sowmya Viswanathan, PhD University Health Network Canada The roundtable session on “Regulating MSC Clinics: Are we doing enough...
Alejandro Barquero, MPharm, MSc DanausGT Biotech Ltd. Spain Simona Stankeviciute, MD, MSc Parexel Lithuania Committee of Advance Therapy (CAT) Minutes of the meetings Minutes of the meeting on 19-21 April 2023 https://www.ema.europa.eu/en...
Michelle Hudson 1 and Kasey Kime 2 1 Clinical Trials Practice Educator, Parkville Cancer Clinical Trials Unit, Australia 2 Director of Regulatory Affairs, Thermo Fisher Scientific, New Zealand . NEW CELL AND GENE THERAPIES APPROVED INTERNATIONALLY It has been a busy two months...
Ashley Krull, Ph.D. Associate Director, Cell Therapy Manufacturing and Engineering James Cancer Hospital Cellular Therapy Laboratory Assistant Professor, Hematology The Ohio State University Columbus, Ohio, United States On March 14th, 2023, the FDA held an engaging virtual...
Darshan Patel, MS Fred Hutch Cancer Center United States FDA Seeks Input on Boosting Data and Technology Capabilities: The US Food and Drug Administration (FDA) is requesting stakeholders’ inputs on how it can advance its data and technology capabilities under the...
Alejandro Barquero, MPharm, MSc DanausGT Biotech Ltd. Spain Simona Stankeviciute, MD, MSc Parexel Lithuania . Committee of Advance Therapy (CAT) Minutes of the meetings: Minutes of the meeting on 18-19 January 2023 https://www.ema.europa.eu/en/documents/minutes/minutes...
Michelle Hudson 1 and Kasey Kime 2 1 Clinical Trials Practice Educator, Parkville Cancer Clinical Trials Unit, Australia 2 Director of Regulatory Affairs , Thermo Fisher Scientific, New Zealand . NEW CELL AND GENE THERAPIES APPROVED INTERNATIONALLY: ...
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...
Fajar Dumadi Regulatory Program Specialist ISCT Head Office The TGA's Good Manufacturing Practice (GMP) Forum was held in Sydney on 21 March 2023 at the International Convention Centre in Darling Harbour. The GMP Forum 2023 provided participants with the opportunity to connect with the TGA...
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...