Workshop “GMP for Advanced Therapy Medicinal Products (ATMP)

Workshop “GMP for Advanced Therapy Medicinal Products (ATMP)

Heidelberg, Germany

Course No 15199


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Andrea Hauser, Jose-Carreras Center, University Hospital Regensburg
Dr Ralf Sanzenbacher, Paul-Ehrlich-Institut; German Federal Agency for Vaccines and Biomedicines
Dr Ohad Karnieli, Karnieli Ltd
Jan-Oliver Karo, PEI, German Federal Agency for Vaccines and Biomedicines

Objectives

This Workshop aims to provide an insight view in the
regulatory requirements on ATMP with a focus on GMP aspects during development and manufacturing of
Advanced Therapy Medicinal Products. Representatives from authority, consulting as well as from science and manufacturers will share their experiences with you and give you the possibility to discuss intensively the special challenges for ATMPs.

Background

Advanced therapy medicinal products (ATMP) are a emerging class of innovative biopharmaceutical medicines , summarizing gene therapy, somatic cell therapy and tissue-engineered products. With the adoption of the ATMP regulation EC 1394/2007, ATMPs are regarded as medicinal products and must consequently comply with current EU drug legislation including GMP. Although pharma industry recently increased their activities to this new area , but the development of these complex products is still focused at universities, hospitals and spin off companies derived thereof (small medium enterprises, SME). This implicates special challenges for compliance these SME with regulatory requirements on marketing authorization and GMP.

Target Group

This course is advisable to people who
Are involved in basic or translational research on cell-based therapy concepts with the perspective of clinical application Are responsible on quality aspects on ATMP
Implement GMP in ATMP manufacturing
Are involved in regulatory inspections of ATMP
Are responsible for GMP requirements during
pre-approval phases

Programme

Tissues, Tissue Preparations and ATMPs: Introduction
Overview on Products and Therapies: Reality and Future
Legal Framework in EU and Germany
CTA, Hospital Exemption and Marketing Authorisation: Steps to Consider in the Development of ATMPs
Ralf Sanzenbacher

Regulatory and Practical Aspects for ATMPs -
Requirements for QPs
Starting materials for ATMPs
Raw/ancillary materials for production
Specifics for process validation and quality control of ATMPs
Responsibilities of the QP - what is different for ATMPs
Dr Andrea Hauser

Requirements on Manufacturing of Cell-based
products under GMP
Important Aspects for Characterisation and Control
Quality of Reagents and Materials
Relevant guidance documents
Inspection Experiences and Findings
Common Deficiencies in Clinical Trial Applications
Ralf Sanzenbacher

GMP-Aspects for ATMPs
GMP background
Impact of Revised GMP Annex 2
Inspections
Case Studies
Dr Hiltrud Horn

Case Study – Manufacture of an ATMP for a phase I/II clinical trial in an academic setting
Installation of a clean room facility for manufacture
of ATMPs in an academic setting
Establishment and validation of the manufacturing process with special focus on GMP-compliant FACS sorting
Application for a phase I/II investigator initiated
clinical trial
Dr Andrea Hauser

GMP Implementation - Practical Industrial
Experiences/ Common pitfalls and issues
Aseptic challenges in cell therapy from media
preparation to final product.
Dealing with research grade raw materials in a
cGMP environment.
Closing the critical gaps in open manipulations
of cell therapy.
Autologous verses Allogeneic cGMP cell therapy
challenges
Cell Therapy specific cGMP challenges and possible solutions.
Ohad Karnieli

Microbiological Safety of ATMPs
Challenges and Critical Aspects
Relevant Guidance Documents
Modern Microbiological Safety Concepts
Case Studies from Microbiological Assessment
Jan Oliver Karo

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