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Paula Salmikangas

  • Paula Salmikangas
  • Co-ordinating Senior Researcher (Fimea) and CAT Chairperson (EMA) Department of Marketing Authorizations, Finnish Medicines Agency and CAT/EMA
    • Day 1 > Plenary Lecture 1 (Speaker)
    • Day2 > Special Topic 2 (Speaker)
      • Critical Attributes of Starting and Raw Materials for the
      • Quality of Cell-based Products

Srinivasan N Kellathur

  • Srinivasan N Kellathur
  • Head Advanced Therapy Products Unit, Health and Sciences Authority
    • Day 1 > Introduction (Speaker)
      • Overview of Cell- and Tissue-based Therapeutic Product Roadmap
    • Day2 > Special Topic 4 (Chair)
      • Recommendations and Closing Remarks (Speaker)

Judith Arcidiacono

  • 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
    • 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
    • Day2 > Special Topic 2 (Chair)

Yoshiaki Maruyama

  • Yoshiaki Maruyama
  • Principal Reviewer Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency
    • Day 1 > Regulatory Update Session 1 (Speaker)
      • Regulatory Framework for Regenerative Medicine in Japan

Constanze Fritsche

  • Constanze Fritsche
  • Case Manager and Regulatory Reviewer Division Authorizations, Department Inspectorate, Unit of Transplant Products, Swiss Agency for Therapeutic Products, Swissmedic
    • Day 1 > Regulatory Update Session 1 (Speaker)
      • Recent Developments in Transplant Product Approvals and Clinical Trial Authorization

Geeta Jotwani

  • Geeta Jotwani
  • Deputy Director General Basic Medical Sciences, Indian Council of Medical Research
    • Day 1 > Regulatory Update Session 1 (Speaker)
      • Regulation of Cellular Therapies in India

Yao-Chang Chen

  • Yao-Chang Chen
  • Professor Department of Hematology, National Taiwan University Hospital
    • Day 1 > Regulatory Update Session 2 (Chair)

Liz Anne Gillham-Eisen

  • Liz Anne Gillham-Eisen
  • Acting Director Office of Policy and International Collaboration Biologics and Genetic Therapies Directorate, Heath Products and Food Branch, Heath Canada
    • Day 1 > Regulatory Update Session 2 (Speaker)
      • Developments and Future Considerations for Regulating Cellular Therapies in Canada
    • Day 2 > Special Topic 1 (Chair)

Wei Wei

  • Wei Wei
  • Reviewer Office of Biological Products of Center for Drug Evaluation, China Food and Drug Administration
    • Day 1 > Regulatory Update Session 2 (Speaker)
      • Introduction of China’s Provisions and Guidelines on Human Stem Cell-based Medicinal Products

Yi-Chu Lin

  • Yi-Chu Lin
  • Associate Researcher Division of Medicinal Products, Taiwan Food and Drug Administration
    • Day 1 > Regulatory Update Session 2 (Speaker)
      • Regulation of Cell Therapy Products in Taiwan

William Hwang

  • William Hwang
  • Head, Senior Consultant and Associate Professor Singapore General Hospital, SingHealth; Duke-NUS Graduate Medical School and Singapore Cord Blood Bank
    • Day 1 > Plenary Lecture 2 (Speaker)
      • Cell Therapy: Singapore Style

Mickey Koh

  • Mickey Koh
  • Senior Consultant and Senior Lecturer, Department of Haematology, St George's Hospital and Medical School
    • Day 1 > Plenary Lecture 2 (Chair)
    • Day 2 > Plenary Lecture 3 (Speaker)
      • Searching for solutions: Cell Therapy Medical Tourism

Ramamoorthy Arivazhagan

  • Ramamoorthy Arivazhagan
  • Senior Manager Quality Assurance, Lonza Biosciences
    • Day 2 > Special Topic 1 (Speaker)
      • Challenges During set-up of GMP manufacturing - Cell therapy Products

Ian Harris

  • Ian Harris
  • Senior Director Cell Therapy, Jansen R&D
    • Day 2 > Special Topic 1 (Speaker)
      • Industry Perspectives on Manufacturing Facilities for Allogeneic and Autologous Cell Therapy Products

Antonio S J Lee

  • Antonio S J Lee
  • CEO and Managing Director MEDIPOST America Inc.
    • Day 2 > Special Topic 1 (Speaker)
      • Commercial manufacturing of allogeneic cell therapy product with BLA: 2 years of market experience from Korea

Yosuke Ozawa

  • Yosuke Ozawa
  • President and CEO Japan Tissue Engineering Company Ltd.
    • Day 2 > Special Topic 1 (Speaker)
      • Challenges of Japan, Forum for Innovative Regenerative Medicine and J-TEC

Steven S Oh

  • 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
    • Day 2 > Special Topic 2 (Speaker)
      • Manufacturing Cellular Products: US FDA Perspectives

Won Shin

  • Won Shin
  • Director Cell and Gene Therapy Products Division, Biopharmaceuticals and Herbal Medicine Evaluation Department, Ministry of Food and Drug Safety
    • Day 2 > Special Topic 2 (Speaker)
      • Microbiological Considerations in Manufacturing Cell Therapy Products

Charlotte Morgan

  • Charlotte Morgan
  • Head of Manufacturing Regeneus Pty Ltd
    • Day 2 > Special Topic 2 (Speaker)
      • Tissue Procurement for Cell-based Therapies

Kazuhiro Takekita

  • Kazuhiro Takekita
  • Reviewer Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency
    • Day 2 > Special Topic 3 (Speaker)
      • Regulatory perspective for ensuring quality and safety of cellular and tissue-based products in Japan

Yong Man Kim

  • Yong Man Kim
  • Scientific Director and Chief Researcher Stem Cell Research Center, Pharmicell Company Ltd.
    • Day 2 > Special Topic 3 (Speaker)
      • Introduction to the product testing of bone marrow stromal stem therapy product Cellgram-AMI.

Jod Mehta

  • Jod Mehta
  • Senior Consultant and Head Duke-NUS Graduate Medical School and Singapore National Eye Centre
    • Day 2 > Special Topic 3 (Speaker)
      • Tissue Engineering Cell-based Therapy in Corneal Reconstruction

Maria Cristina Galli

  • Maria Cristina Galli
  • Senior Researcher and GMP Inspector Department of Cell Biology and Neurosciences, Istituto Superiore di Sanita
    • Day 2 > Special Topic 4 (Speaker)
      • GMP Requirements for Cell-Based Medicinal Products: Critical Issues

Choon Wee Goh

  • Choon Wee Goh
  • Regulatory Consultant Audits Branch, Audit and Licensing Division, Health Products Regulation Group/Health Sciences Authority
    • Day 2 > Special Topic 4 (Speaker)
      • What is to be Expected in GMP Inspection for Cell- and Tissue-based Therapeutic Products?: From Singapore Perspective