Gene and Cell Therapy: Regulatory CMC, Quality Development and Manufacturing
23-23

June 2020

ONLINE

TBA

About

Preserving rapidly increasing complexity and growing concerns related to cell & gene therapies, and meeting emerging challenges in the process development, quality / CMC (Chemistry Manufacturing and Controls) technical and regulatory requirements for CGT, best practices to be assessed, novel approaches to be taken, and new paths to be defined. Gene and Cell Therapy LIVE webinar on 4 June 2020, affiliated with the 2nd Gene and Cell Therapy: Quality Developments to Commercialization Summit, leading by experts with many years of experience in ATMP...

Preserving rapidly increasing complexity and growing concerns related to cell & gene therapies, and meeting emerging challenges in the process development, quality / CMC (Chemistry Manufacturing and Controls) technical and regulatory requirements for CGT, best practices to be assessed, novel approaches to be taken, and new paths to be defined. Gene and Cell Therapy LIVE webinar on 4 June 2020, affiliated with the 2nd Gene and Cell Therapy: Quality Developments to Commercialization Summit, leading by experts with many years of experience in ATMPs, will deliver an interactive approach to: • learn from subject-specific case studies, • exchange professional knowledge and expectations, featuring cell & gene therapy medicinal products, • get guidance and competent advice, addressing critical issues and uncertainty in development, manufacturing and control of CGT, as well as clarification of regulatory guidelines. Join virtually an interactive discussion and practical presentations, exploring industry standards and advancements to: • accelerate gene and cell product development, • get more gene and cell therapy products successfully approved, • have a controlled manufacturing process, • deliver safe and commercially viable CGT products. After the event, you will receive a digital certificate of attendance.

more info
Who Should Attend

Chief Executives, Vice Presidents, Directors, Heads, Leaders and Managers specialising in:

  • Advanced Therapy Medicinal Product (ATMP)
  • Bioprocessing
  • CAR-T
  • Cell Therapy
  • Cellular Therapy
  • Chemistry, Manufacturing, and Control (CMC)
  • Gene Therapy
  • Gene Therapy Medicinal Products (GTMPs)
  • Immuno-Oncology
  • Immunology Chemistry
  • Legal/IP
  • Market Access
  • Oncology
  • Production Engineering
  • Quality Control
  • Regenerative Medicine
  • Safety
  • Stem Cell
  • Analytical
  • Biotherapeutics
  • Cell Engineering
  • Cellular Immunotherapy
  • Clinical Development
  • Compliance
  • GMP
  • Cell-Based Medicinal Products (CBMPs)
  • Immunology
  • Immunotherapy
  • Manufacturing
  • Medical Affairs
  • Process Development
  • Quality Assurance
  • Research and Development (R&D)
  • Regulatory
  • Sales
  • Supply Chain
Key Practical Learning Points of the Summit

CMC technical and regulatory compliance to empower cell and gene therapy products development roadmap
Optimised cell and gene therapies process development, manufacturing, cost and quality efficiency
Speakers
Dr. James Wang, US

Global Quality Auditor, Cell & Gene Therapy

Novartis

Dr. Axel Ståhlbom, SE

Principal Consultant / Biologics & Preclinical

ProPharma Group

Dr. Christiane Niederlaender, UK

Director

AMBR Consulting Ltd

Karen Magers, US

Head of Regulatory Affairs, Cell and Gene Technologies

Lonza Pharma Biotech & Nutrition

Dr. Rajesh Thangapazham, US

Head of Regulatory Strategy & Innovation, Cell & Gene Technologies

Lonza Pharma Biotech & Nutrition

Dr. Ali Mohamed, US

VP CMC

Immatics Biotechnologies

Dr. Alessandra Gatti, IT

Cell Process Development Manager

MolMed

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