This book is intended as a one-stop resource for availability of state-of-the-art information related to cell and gene therapy products for researchers, scientists, management and other academic and research institutions working in the field.
This book is intended as a one-stop resource for availability of state-of-the-art information related to cell and gene therapy products for researchers, scientists, management and other academic and research institutions working in the field.
History of Gene Therapy Products Overview of technologies applied to gene therapy products History of Cell Therapy Products Overview of technologies applied to cell therapy products - what it entails Gene Therapy Manufacturing- an Overview on Viral Vectors and Plasmid Manufacturing, Does it suffice Basic considerations - Manufacturing Processes: - Cell therapy products Analytical Methods Facility and equipment considerations Control of adventitious agent contamination during manufacture of cell and gene therapy products Quality Considerations from Clinical to Commercial Manufacturing Regulatory Compliance and Approval CMC Submissions Validation, Verification and Qualification Considerations Clinical development of cell and gene therapies -from first-in-human to postmarketing studies Risk-based approach in the development of cell and gene therapy products Current global regulatory landscape Comparison of EU and US Regulatory Requirements Regulatory Landscape for Gene and Cell Therapies Canada China Regulation of cell product and gene therapy South Asia Countries Japan Regulatory Pathway for Cell, Tissue and Gene Therapy Products in Singapore Regulatory Pathway for Cell and Gene Therapy Products in Malaysia The Regulation of Cell and Gene Therapy Products in Australia and New Zealand Pricing and market access: the market access hurdle Training Approaches to Build Cell and Gene Therapy Workforce Capacity Lessons Learned - Successes and Pitfalls Pitfall Avoidance through Cross-Functional Development Approach
History of Gene Therapy Products Overview of technologies applied to gene therapy products History of Cell Therapy Products Overview of technologies applied to cell therapy products - what it entails Gene Therapy Manufacturing- an Overview on Viral Vectors and Plasmid Manufacturing, Does it suffice Basic considerations - Manufacturing Processes: - Cell therapy products Analytical Methods Facility and equipment considerations Control of adventitious agent contamination during manufacture of cell and gene therapy products Quality Considerations from Clinical to Commercial Manufacturing Regulatory Compliance and Approval CMC Submissions Validation, Verification and Qualification Considerations Clinical development of cell and gene therapies -from first-in-human to postmarketing studies Risk-based approach in the development of cell and gene therapy products Current global regulatory landscape Comparison of EU and US Regulatory Requirements Regulatory Landscape for Gene and Cell Therapies Canada China Regulation of cell product and gene therapy South Asia Countries Japan Regulatory Pathway for Cell, Tissue and Gene Therapy Products in Singapore Regulatory Pathway for Cell and Gene Therapy Products in Malaysia The Regulation of Cell and Gene Therapy Products in Australia and New Zealand Pricing and market access: the market access hurdle Training Approaches to Build Cell and Gene Therapy Workforce Capacity Lessons Learned - Successes and Pitfalls Pitfall Avoidance through Cross-Functional Development Approach
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