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Webinar: GMP regulations in Advanced Therapy Medicinal Products

Spezial Webinar, August 25, 2021

Dealing with European and American regulations for ATMP manufacturing

The current guide for ATMPs, EU GMP guide Part IV ‘GMP for ATMPs’, will be discussed in detail in this course.
The available EMA/FDA regulatory authority guidance documents for ATMPs will be thoroughly presented and discussed.
PTS WebinarSpezial

Informationen

amAugust 25, 2021
ThemengebietThemengebiet: GMP
PTS-IDPTS-ID: 4245
TeilnehmergebührTeilnehmergebühr: 260,- Euro
BildungspunkteBildungspunkte: 125
SpracheSprache: EN

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What are ATMPs?


Advanced therapy medicinal products (ATMP) are gene therapy, somatic cell therapy or tissue-engineered products regulated under (EC) No. 1394/2007 to guarantee the highest level of health protection for patients.

ATMPs are often developed in an academic or hospital environmental setting under quality systems different to those typically required for the manufacture of conventional medicinal products. There has been a surge in development of Advanced Therapy Medicinal Products (ATMPs) in the EU and the USA. Many start-ups have entered into manufacturing of ATMPs.

Which GMP regulations apply?


The basic rules for Good Manufacturing Practices (GMPs) and quality of traditional pharmaceutical manufacturing are well established, however, for ATMPs these are still new and under development. The current guide for ATMPs, EU GMP guide Part IV ‘GMP for ATMPs’, will be discussed in detail in this course.

The manufacturing of ATMP presents challenges in ensuring product quality, such as the safety and the variability of the starting materials, the quality of the raw materials, contamination during the entire manufacturing cycle, the limitations of the analytical methods available to characterize therapy products.

The environment of the ATMP-Manufacturing needs to be well understood, controlled and adapted by common sense GMP and quality principles. The available EMA/FDA regulatory authority guidance documents for ATMPs will be thoroughly presented and discussed in the course.

The GMP regulations support the biotechnological and medical development in the field of ATMPs (i.e. gene therapies, somatic cell therapies and tissue engineered products) though guidelines such as manufacturing of autologous products, automated production, outsourced reconstitution, and gene editing such as CRISPR and immunomodulators. Currently, these biotechnologies must comply with the general GMP guidelines set out by the FDA and EMA.

Evaluation of risks in ATMP manufacturing


Both European and US-American guidelines follow a risk-based approach which encourages manufacturers to design organizational, technical and structural measures appropriate to the specific risks of the product and the used manufacturing processes. The evaluation of risks and effectiveness of the manufacturing processes, including the controls and mitigation measures, should be based on current scientific knowledge and the manufacturer’s accumulated experience.

They define a number of precautions and checks to improve the safety of the finished product. The specified guidelines should simplify the detection of nonconformity that affects product safety and efficacy. For example, the manufacturers should establish specifications for the starting materials which should be agreed with the safety data determined scientifically. These specifications should cover aspects of the production, testing and control, storage, and other aspects of handling and distribution as appropriate.

ATMP manufacturing should comply with the basic GMP principles such as having an adequate number of personnel with appropriate qualifications and adequate practical experience relevant to the intended operations. The guidelines require ATMP manufacturers to ensure that premises are designed to minimize the opportunity for cross-contamination, the risk of errors and adverse effects on the product quality. Furthermore, equipment must be fit for the intended purpose and documentation systems must be designed to control, monitor and record all activities which may affect the quality of the ATMPs.

Programme

Pharmaceutical Quality System of advanced therapy medicinal products
  • personnell
  • premises
  • equipment
  • documentation

Objectives

The course trains the attendees on dealing with the European and the American regulations for ATMP manufacturing. The attendees will be able to identify the EMA and the FDA regulations regarding GMP manufacturing of ATMPs. The attendees will learn how to implement the GMP basics in the manufacturing of biopharmaceuticals and ATMPs.

Who should attend

This course is designed for those involved or interested in the manufacturing, quality and GMP compliance of ATMPs, including start-up founders, ATMP scientists, Qualified Persons, directors and managers/supervisors, senior managers, QA/QC, regulatory, manufacturing and process development personnel.

Specifics

Interactive presentation Experience exchange among attendees Individual questions can be discussed with other attendees or the speaker

Industry sectors

Manufacturers of ATMPs Start-ups with or without own manufacturing facility Consultants for ATMP development and clinical research Scientist who are planning to move their product from animal model to patient Clinical study organizations specialized in ATMPs research

Informationen

Was ist ein PTS Webinar?
Ein Webinar ist ein interaktives, web-basiertes live Seminar. Sie sehen den Referenten im Video und verfolgen gleichzeitig die Präsentation.

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Dauer
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Dokumentation
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Bonusmaterial: Bücher und Produkte gratis
Teilnehmer dieser Veranstaltung erhalten exklusiv und gratis diese Bücher und Produkte
Zu diesem Angebot liegen keine kostenlosen Produkte vor.
Hier finden Sie weiterführende Informationen
This webinar introduces you to dealing with European and American regulations for ATMP manufacturing; EU GMP guide Part IV and EMA/FDA regulations.

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Termin

am: August 25, 2021,
Beginn: 11:00 Uhr, Ende: ca. 12:30 Uhr

Teilnahmegebühr

260,- € zzgl. aktuell gültiger Mehrwertsteuer
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