Live Online Conference: Quality, Safety and GMP for Advanced Therapy Medicinal Products (ATMPs)
Im Auftrag der ECA Academy

Live Online Conference: Quality, Safety and GMP for Advanced Therapy Medicinal Products (ATMPs) Im Auftrag der ECA Academy

Seminar Nr. 18397

All times mentioned are CET.

Kosten

Für dieses Online Training ist keine Aufzeichnung verfügbar. Habe Sie Interesse an einem kommenden Live Online Training zu diesem Thema teilzunehmen? Wünschen Sie individuelle Beratung zu unserem Schulungsangebot? Dann kontaktieren Sie uns.

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

Sprecher

Dr Rüdiger Alt, Novartis
Dr Hans-Georg Eckert, Valicare
Dr Elena Ferber, Labor LS
Dr  Jessica Horbelt, Fraunhofer Institute for Manufacturing Engineering and Automation
Dr Anette Jork, BioNTech
Dr Christoph Peter,  BioNTech
Dr Christoph Prinz, BioNTech
Dr Christianne Reijnders, The Dutch Health and Youth Care Inspectorate 
Dr Ralf Sanzenbacher,  PEI, German Federal Agency for Vaccines and Biomedicines
Mag. Gabriela Schallmeiner, Inspection Ready
Prof. Michael Schmitt, University Hospital Heidelberg
Dr Jan Schrooten, Antleron
Dr Astrid Schwantes, PEI, German Federal Agency for Vaccines and Biomedicines

Zielsetzung

This Live Online Conference provides a comprehensive overview of the current regulatory requirements for the development, manufacture and approval of Advanced Therapy Medicinal Products (ATMP). Representatives of regulatory authorities, experts from small-scale and large-scale production, QC laboratories and consultants will report on their practical experiences. From the construction of a new production facility to the introduction of a quality system and the final sterility test, all relevant topics directly related to ATMPs will be covered.

Hintergrund

Modern systems of regenerative medicines, especially ATMPs (gene therapeutics, somatic cell-based products and tissue-based products) represent an innovative group of drugs that is becoming increasingly important. With the introduction of several regulatory guidelines e.g. of the European Directive EC 1394/2007 for ATMP, such products were classified as medicinal products and must therefore comply as such with the EU requirements for medicinal products. Although the biopharmaceutical industry has considerably intensified its activities in this field, many of these products are developed and manufactured at universities, hospitals and in small- and medium-sized companies. These university or medical origins result in special challenges for the respective institutions as well as for the regulatory authorities in fulfilling the compliance requirements for quality, safety and GMP aspects and approval. This is also underlined by commonly occurring operating conditions, e.g. the open manipulation of cells and tissues, which are necessary for obtaining such products on a medical/surgical level or by the short shelf life of the obtained final product.

This results in a whole range of extraordinary requirements:
  •  the consideration of later requirements during development and in clinical phases
  •  the implementation of quality assurance requirements during aseptic production
  •  the use of alternative methods for analysis and microbiological control and the demonstration of comparability with conventional methods
  •  the handling of out of specification (OOS) / and out of limit (OOL) results during product testing and the possibility of batch release

Zielgruppe

This Live Online Conference is aimed at all persons who
  •  are involved in basic or translational research on cell-based therapy concepts with the perspective of clinical application,
  •  are involved in the extraction and manufacture of cells, tissues and ATMPs,
  •  are responsible for quality assurance and control of cells, tissues and ATMPs,
  •  are responsible for microbiological or analytical testing,
  •  perform inspections or audits of ATMP facilities,
  •  are responsible for GMP requirements during pre-approval phases,
  •  deal with authorisation.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

Programme Day 1
Provisional timetable, the actual schedule may vary depending on the situation.

09.00 -09.15 h Welcome and Organisationals

09.15 – 10.15 h
Regulatory Developments
  •  New and revised  guidelines
  •  Other relevant documents
  •  Current experiences and expectations
10.15 – 11.15 h
Development of an adaptable, modular strategy for quality control of cell-based therapies
  • Evaluation of existing technologies for quality control of ATMP
  •  Development of new technologies and diagnostics for the quality control of various cell therapeutics
  •  Automation and modular integration of the different methods/products/processes and their adaptation for high throughput
11.15 – 11.30 h  Break

11.30 – 12.30 h
Risk-based Approach and Evaluation is the Leading Tool towards Manufacturing Authorization for iATMPs
  • European GMP guideline Part IV:GMP for ATMPs
  • Gaining flexibility by professional risk reduction  time to manufacturing authorization
12.30 – 13.00 h 
Questions and Answers

13.00 – 14. 00 h  Break

14.00 15.00 h
Cell by Design®, a Quality-Focused Process Development Roadmap for ATMP
  •  Software for risk-based ATMP process development and data driven decision making
  •  Quality by design principles coupled to ATMP legislations, standards and guidelines
  •  Master quality, manufacturability and scalability of ATMP product and process
  •  Enable QC cost-effectiveness by parametric release
15.00- 16.00 h
A Case Study  - Optimizing Manufacturing
  •  Patient individualized cancer treatment using targeted RNAs
  •  The challenges of patient individualized medicines
  •  The challenge of small batches in combination with large batch numbers
  •  How to establish high throughput manufacturing - Dos and Don’ts
16.00 – 16.15 h Break

16.15 - 17.15 h
In-house Production of CAR-T Cells
  •  Requirements for hardware and procedures,
  •  Regulatory affairs (with local/federal authorities
17.15 – 18.00 h 
Questions and Answers
 
Programme Day 2

08.30 – 09.15 h
ATMP Challenges for a QP
  •  A glimpse on the legal framework
  •  The complexity
  •  ATMP specific challenges
  •  What you should know about working with a QP
09.15 – 10.00 h
ATMP GMP Inspection Experiences
  •  Findings
  •  Pitfalls
  •  Hospital Exemption
10.00 – 10.15 h  Break

10.15 – 11.00 h
Process Optimization for Individualized ATMPs - a Modern Aseptic Filling for Small Batches
  • Hygiene monitoring in closed Isolators required?
  •  Regulatory challenges
11.00 – 11.45 h
Strategies for Validating Nucleic Acid-based Techniques for Testing for the Absence of Mycoplasma
  •  NAT-Techniques
  •  Strategies for validation/suitability tests
  •  Pitfalls and practical examples
11.45 – 12.15 h 
Questions and Answers

12.15 – 13.15 h  Break

13.15 – 14.00 h
Virus Safety Concepts for ATMPs
  •  Safety of raw and starting materials
  •  Serum and serum replacement(s) for cell based products
  •  Testing methodologies (NGS?)
  •  Virus inactivation and removal
14. 00 – 15.00 h
Treating Patients with OOS Batches - when Physicians Request Non-Conforming ATMPs
  •  Regulatory Framework
  •  Perspective and Expectations from Patients, Physicians, Sponsors, Manufacturers, QPs, Authorities - EU vs. US
  •  Batch Control, Review and Release Process
15.00 – 15.15 h  Break

15.15 – 16.15 h
Exceptional Provision of ATMPs Affected by OOS Results
  •  Regulatory Framework
  •  OOS investigation and risk assessment
  •  Risk / benefit evaluation and exceptional provision request
  •  Exceptional batch supply and Health Authority notifications
16.15 – 17.00 h 
Questions and Answers

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