Developing a quality control program for advanced therapy medicinal products in Europe
Published: October 2, 2019
Regulatory considerations for decentralized manufacture of ATMPs
Published: October 2, 2019
Health Technology Assessment of Gene Therapies in Europe and the USA: Analysis and Future Considerations
Published: September 4, 2019
The diversity in regenerative medicines regulations in Europe, USA and Japan
Published: September 4, 2019
Value demonstration and advanced therapies: the ARM perspective
Published: September 4, 2019
Addressing challenges in meeting chemistry, manufacturing and control regulatory requirements for gene therapy products
Published: July 24, 2019
Should cell- and gene-therapy developers engage with regulatory authorities?
Published: July 22, 2019
Need for regulatory compliance in research: what is Good Laboratory Practice and what is a validated assay?
Published: July 22, 2019
Strategic & regulatory insights for gene therapy preclinical-clinical translation in CNS
Published: July 22, 2019
Preclinical considerations for assessment of cellular & gene therapy products: FDA perspective
Published: July 22, 2019
Facilities for the future: design & qualification of aseptic manufacturing facilities for cell and gene therapy
Published: June 25, 2019
EU market authorisation strategy: lessons from the first 22 ATMP submitted to the EMA
Published: June 25, 2019
Experiences from Japan: conditional and time-limited approval – an early approval scheme for regenerative medical products
Published: June 24, 2019
US FDA goals and priorities for cell & gene therapy regulation
Published: June 24, 2019
Gene therapy success: how to keep its promises and improve – a regulatory perspective
Published: June 24, 2019
The impact of regulatory strategy on business goals: uniQure’s Phase 3 product optimization for hemophilia B
Published: June 24, 2019
Korea’s evolving regulatory landscape for cell & gene therapies
Published: June 24, 2019
European developments in ATMP Regulation
Published: June 24, 2019
Update on the regulatory environment for ATMPs in Israel
Published: June 24, 2019
Using patient outcomes data to inform and advance the development of emerging cell and gene therapies
Published: June 3, 2019
Process validation for recombinant adeno-associated virus vectors in rare diseases: challenges for MAAs
Published: May 16, 2019
Preparing to navigate European regulatory requirements for gene therapy process validation
Published: May 16, 2019
Planning for Success: Emerging GMP-Grade Raw Materials & Technologies for Cell Therapy
Published: April 15, 2019
Cell Therapy Quality/CMC & Analytics – Full Spotlight
Published: February 21, 2019
European regulator’s perspective: best practice & future directions in cell therapy CMC
Published: February 15, 2019
Commercial Lessons for Clinical Success
Published: February 4, 2019
Management of ‘out of specification’ commercial autologous CAR-T cell products
Published: December 17, 2018
Joined-up thinking: success criteria for tomorrow’s viral vector production platforms
Published: December 3, 2018
New Gene Therapy CMC Guidance from the FDA – A Breakthrough in Regulation or Something More Generic?
Published: August 15, 2018
Accelerated Access of Advanced Regenerative Therapies: an Industry Perspective
Published: August 6, 2018
