CTT
- Paula Salmikangas
- Co-ordinating Senior Researcher (Fimea) and CAT Chairperson (EMA) Department of Marketing Authorizations, Finnish Medicines Agency and CAT/EMA
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Day 1 > Plenary Lecture 1 (Speaker)
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Day2 > Special Topic 2 (Speaker)
- Critical Attributes of Starting and Raw Materials for the
- Quality of Cell-based Products
- Srinivasan N Kellathur
- Head Advanced Therapy Products Unit, Health and Sciences Authority
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Day 1 > Introduction (Speaker)
- Overview of Cell- and Tissue-based Therapeutic Product Roadmap
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Day2 > Special Topic 4 (Chair)
- Recommendations and Closing Remarks (Speaker)
- Judith Arcidiacono
- International Regulatory Expert and Standards Development Liaison Office of Cellular, Tissue and Gene Therapy, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
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Day 1 > Introduction (Speaker)
- Introduction and Outline of International Pharmaceutical Regulators Forum ？ Cell Therapy Group
- Regulatory Update Session 1 (Speaker)4_2014 AHC-HSA CTT Workshop_Judith Ardiacono US FDA:PDF file download U.S. FDA Regulatory Innovation for Cell Therapy Products
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Day2 > Special Topic 2 (Chair)
- Yoshiaki Maruyama
- Principal Reviewer Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency
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Day 1 > Regulatory Update Session 1 (Speaker)
- Regulatory Framework for Regenerative Medicine in Japan
- Constanze Fritsche
- Case Manager and Regulatory Reviewer Division Authorizations, Department Inspectorate, Unit of Transplant Products, Swiss Agency for Therapeutic Products, Swissmedic
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Day 1 > Regulatory Update Session 1 (Speaker)
- Recent Developments in Transplant Product Approvals and Clinical Trial Authorization
- Geeta Jotwani
- Deputy Director General Basic Medical Sciences, Indian Council of Medical Research
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Day 1 > Regulatory Update Session 1 (Speaker)
- Regulation of Cellular Therapies in India
- Yao-Chang Chen
- Professor Department of Hematology, National Taiwan University Hospital
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Day 1 > Regulatory Update Session 2 (Chair)
- Liz Anne Gillham-Eisen
- Acting Director Office of Policy and International Collaboration Biologics and Genetic Therapies Directorate, Heath Products and Food Branch, Heath Canada
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Day 1 > Regulatory Update Session 2 (Speaker)
- Developments and Future Considerations for Regulating Cellular Therapies in Canada
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Day 2 > Special Topic 1 (Chair)
- Wei Wei
- Reviewer Office of Biological Products of Center for Drug Evaluation, China Food and Drug Administration
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Day 1 > Regulatory Update Session 2 (Speaker)
- Introduction of China’s Provisions and Guidelines on Human Stem Cell-based Medicinal Products
- Yi-Chu Lin
- Associate Researcher Division of Medicinal Products, Taiwan Food and Drug Administration
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Day 1 > Regulatory Update Session 2 (Speaker)
- Regulation of Cell Therapy Products in Taiwan
- William Hwang
- Head, Senior Consultant and Associate Professor Singapore General Hospital, SingHealth; Duke-NUS Graduate Medical School and Singapore Cord Blood Bank
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Day 1 > Plenary Lecture 2 (Speaker)
- Cell Therapy: Singapore Style
- Mickey Koh
- Senior Consultant and Senior Lecturer, Department of Haematology, St George's Hospital and Medical School
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Day 1 > Plenary Lecture 2 (Chair)
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Day 2 > Plenary Lecture 3 (Speaker)
- Searching for solutions: Cell Therapy Medical Tourism
- Ramamoorthy Arivazhagan
- Senior Manager Quality Assurance, Lonza Biosciences
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Day 2 > Special Topic 1 (Speaker)
- Challenges During set-up of GMP manufacturing - Cell therapy Products
- Ian Harris
- Senior Director Cell Therapy, Jansen R&D
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Day 2 > Special Topic 1 (Speaker)
- Industry Perspectives on Manufacturing Facilities for Allogeneic and Autologous Cell Therapy Products
- Antonio S J Lee
- CEO and Managing Director MEDIPOST America Inc.
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Day 2 > Special Topic 1 (Speaker)
- Commercial manufacturing of allogeneic cell therapy product with BLA: 2 years of market experience from Korea
- Yosuke Ozawa
- President and CEO Japan Tissue Engineering Company Ltd.
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Day 2 > Special Topic 1 (Speaker)
- Challenges of Japan, Forum for Innovative Regenerative Medicine and J-TEC
- Steven S Oh
- Team Leader, Device and Combination Product Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
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Day 2 > Special Topic 2 (Speaker)
- Manufacturing Cellular Products: US FDA Perspectives
- Won Shin
- Director Cell and Gene Therapy Products Division, Biopharmaceuticals and Herbal Medicine Evaluation Department, Ministry of Food and Drug Safety
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Day 2 > Special Topic 2 (Speaker)
- Microbiological Considerations in Manufacturing Cell Therapy Products
- Charlotte Morgan
- Head of Manufacturing Regeneus Pty Ltd
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Day 2 > Special Topic 2 (Speaker)
- Tissue Procurement for Cell-based Therapies
- Kazuhiro Takekita
- Reviewer Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency
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Day 2 > Special Topic 3 (Speaker)
- Regulatory perspective for ensuring quality and safety of cellular and tissue-based products in Japan
- Yong Man Kim
- Scientific Director and Chief Researcher Stem Cell Research Center, Pharmicell Company Ltd.
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Day 2 > Special Topic 3 (Speaker)
- Introduction to the product testing of bone marrow stromal stem therapy product Cellgram-AMI.
- Jod Mehta
- Senior Consultant and Head Duke-NUS Graduate Medical School and Singapore National Eye Centre
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Day 2 > Special Topic 3 (Speaker)
- Tissue Engineering Cell-based Therapy in Corneal Reconstruction
- Maria Cristina Galli
- Senior Researcher and GMP Inspector Department of Cell Biology and Neurosciences, Istituto Superiore di Sanita
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Day 2 > Special Topic 4 (Speaker)
- GMP Requirements for Cell-Based Medicinal Products: Critical Issues
- Choon Wee Goh
- Regulatory Consultant Audits Branch, Audit and Licensing Division, Health Products Regulation Group/Health Sciences Authority
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Day 2 > Special Topic 4 (Speaker)
- What is to be Expected in GMP Inspection for Cell- and Tissue-based Therapeutic Products?: From Singapore Perspective
