GMP for Advanced Therapy Medicinal Products (ATMP)
Im Auftrag der ECA Academy

21-22 June 2018

Berlin, Germany

Seminar Nr. 16648

Unser Seminarservice

Kosten

Die Veranstaltung hat bereits stattgefunden. Suchen Sie nach Wiederholungsterminen und weiteren, themenbezogenen Seminaren auf der Seite GMP Seminare/-Konferenzen nach Thema.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Rainer Gnibl, Government of Upper Bavaria
Dr Andrea Hauser, Jose-Carreras Center, University Hospital Regensburg
Dr Hiltrud Horn, Horn Pharmaceutical Consulting
Jan-Oliver Karo, PEI, German Federal Institute for Vaccines and Biomedicines
Dr Matthias Renner, Paul-Ehrlich-Institut; German Federal Institute for Vaccines and Biomedicines
Niina Taylor, Pfizer

Zielsetzung

Relating to the fact of the new GMP Guidelines on GMP requirements for ATMP and the ongoing scientific developments, this Workshop aims to provide an insight view in the regulatory requirements on ATMP with a focus on GMP aspects. During development as well as during manufacturing of Advanced Therapy Medicinal Products for clinical trials and on industrial level. 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.

Hintergrund

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 academic/medical roots of these SME implicates generally special challenges to stay in compliance with regulatory requirements on marketing authorization and GMP. Especially open manipulations of cells and tissues on medical level necessitate adapted procedures.With the publishing of the new stand-alone guidance document on the GMP requirements in November 2017, EMA tried to define the expected standards for this special kind of medicinal products.

Zielgruppe

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

Programm

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

The New EU-GMP Guideline for ATMP (Part I)

Guideline Overview
ATMPs & Quality Risk Management
Zone-Concept for ATMP Facility
Focus: Qualification & Monitoring

The New EU-GMP Guideline for ATMP (Part II)

Focus: Process-Validation & Media Fill
Focus: Documentation
How to certify/release an ATMP Batch
Specific Products/Processes

GMP for ATMP – Considerations to European and US Requirements from industrial point of view

Essential Effects of the New Guideline
Challenges in Practice
US Requirements

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

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

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

GMP Implementation - Practical Industrial Experiences

Challenges in aseptic manufacturing
Dealing with research grade raw materials in a cGMP environment
Dealing with Contract Manufacturing organisations
Specific cGMP challenges and possible solutions

Microbiological Safety of ATMPs

Challenges and Critical Aspects
Relevant Guidance Documents
Modern Microbiological Safety Concepts
Case Studies from Microbiological Assessment

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GMP for Advanced Therapy Medicinal Products (ATMP)Im Auftrag der ECA Academy