2024-12-21 2024-12-21 , online online, 390 € zzgl. MwSt. Dr. Beatrix Metzner https://www.forum-institut.de/seminar/25122496-e-learning-stability-testing-in-the-ich-region/referenten/25/25_12/25122496-e-learning-stability-testing-in-the-ich-region_metzner-beatrix.jpg e-Learning: Stability Testing in the ICH Region

This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.

Topics
  • Module 1: Regulatory requirements
  • Module 2: Factors that influence stability testing
  • Module 3: Stability test requirements
  • Module 4: Bracketing and matrixing
  • Module 5: Shelf life and extrapolation - Challenges
  • Module 6: Impact of changes on stability
  • Module 7: Challenges for biotechnological products


Who should attend
This e-Learning programme addresses the needs of those working in the pharmaceutical industry. It will particularly benefit those needing a good understanding of the requirements, data and challenges of stability testing.
Aims and objectives
This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.
This e-Learning will provide you with:
  • knowledge of regulatory frameworks in Europe, the ICH region and the US;
  • an understanding of the chemical, physical and microbiological factors influencing stability testing, as well as container closure systems and the transportation;
  • in-depth knowledge of stability study requirements;
  • the ability to apply bracketing and matrixing;
  • knowledge of the data needed for extrapolation and defining the shelf life of a product;
  • an understanding of the impact of changes on stability; and
  • knowledge of the stability specifics of biological products.
This e-Learning was developed in January 2018.
Your benefit

The e-learning format allows you to create your own schedule, pause and rewind the video at any time, and avoid being pressed for time. You will benefit from the long-term experience of the expert Dr Beatrix Metzner and gain a good overview on the important aspects that concern the challenges of stability testing in practice. Feel free to pose questions while completing each single or after having completed all seven videos.

e-Learning: Stability testing in the ICH-region

e-Learning: Stability
Testing in the ICH Region

- e-Learning -

Benefits
  • Up-to-date expert knowledge
  • Flexibility in location and timing
  • You establish your own learning speed
  • Tests and feedback

Webcode 25122496

Jetzt buchen

JETZT Buchen
Referent

Dr. Beatrix Metzner

Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss

Global Head of CMC Management Biopharma Dr. Beatrix Metzner studied chemistry at the University of Regensburg and Freiburg, Germany, specializing in biochemistry. Her professional career began at MediGene AG. In 2005, she joined Merck KGaA, where she worked as Director Global Regulatory Oncology until November 2013. At Boehringer Ingelheim, she held various management positions. Since January 2023 she acts as Global Head of CMC Management Biopharma. Dr Beatrix Metzner is a highly accomplished professional with more than 20 years experience in the CMC regulatory field of new biological entities (NBEs) and biosimilars.

Alles auf einen Blick

Termin

anytime

anytime

Zeitraum

Veranstaltungsort

online

online

Downloads
PROSPEKT
PROSPEKT
Gebühr

Veranstaltung - 390 € zzgl. MwSt.
The fee for a single account that is valid for 90 days is €390 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end. Our general terms and conditions (dated 1 Juni 2024) apply and are available upon request. We can send them to you anytime or you can find them on the internet at www.forum-institut.com/t&c. Please refer to the section 'Special terms and conditions for online offers'.


SPECIAL OFFERS
GMP-Aufbauwissen für Qualitätsmanager
16.01.2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.200,00 €
CMC Writing
18/02/2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.240,00 €
APIs in Regulatory Affairs
19. - 20.02.2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.640,00 €
GMP essentials for quality management
25-26/02/2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.940,00 €
GMP-Daten für CMC/Regulatory Affairs kompetent aufbereiten
06.02.2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.240,00 €
Biotechnologie: Grundlagen, Herstellungs- und Zulassungsanforderungen
25. - 26.02.2025, Heidelberg
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
2.140,00 €
Toxicology and beyond: Safety assessment in drug development
17-18/02/2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.940,00 €
CMC requirements in Asia, Japan and Eastern Europe
04-25/03/2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.300,00 €
Der CMC-Manager in Regulatory Affairs
29. - 30.04.2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.940,00 €
Pharmazeutische Wirkstoffe: Von der Syntheseentwicklung zum CMC Dossier
08.05.2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.240,00 €
Pharmazeutische Entwicklung
03.06.2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.240,00 €
Biopharmaceuticals
03-05/06/2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.240,00 €
Key Topics der CMC-Dokumentation: Vom GMP- zum RA-Dokument
10.07.2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.240,00 €
Prozessvalidierung - Anforderungen an CMC-Daten
26.08.2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.240,00 €
CMC Management in Regulatory Affairs
22-23/05/2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.940,00 €

Veranstaltung - 390 € zzgl. MwSt.
The fee for a single account that is valid for 90 days is €390 (excluding German VAT). You can access the modules as often as you want during this time. You will be awarded a certificate of completion at the end. Our general terms and conditions (dated 1 Juni 2024) apply and are available upon request. We can send them to you anytime or you can find them on the internet at www.forum-institut.com/t&c. Please refer to the section 'Special terms and conditions for online offers'.

SPECIAL OFFERS
GMP-Aufbauwissen für Qualitätsmanager
16.01.2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.200,00 €
CMC Writing
18/02/2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.240,00 €
APIs in Regulatory Affairs
19. - 20.02.2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.640,00 €
GMP essentials for quality management
25-26/02/2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.940,00 €
GMP-Daten für CMC/Regulatory Affairs kompetent aufbereiten
06.02.2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.240,00 €
Biotechnologie: Grundlagen, Herstellungs- und Zulassungsanforderungen
25. - 26.02.2025, Heidelberg
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
2.140,00 €
Toxicology and beyond: Safety assessment in drug development
17-18/02/2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.940,00 €
CMC requirements in Asia, Japan and Eastern Europe
04-25/03/2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.300,00 €
Der CMC-Manager in Regulatory Affairs
29. - 30.04.2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.940,00 €
Pharmazeutische Wirkstoffe: Von der Syntheseentwicklung zum CMC Dossier
08.05.2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.240,00 €
Pharmazeutische Entwicklung
03.06.2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.240,00 €
Biopharmaceuticals
03-05/06/2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.240,00 €
Key Topics der CMC-Dokumentation: Vom GMP- zum RA-Dokument
10.07.2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.240,00 €
Prozessvalidierung - Anforderungen an CMC-Daten
26.08.2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.240,00 €
CMC Management in Regulatory Affairs
22-23/05/2025, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
1.940,00 €

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.

Topics

  • Module 1: Regulatory requirements
  • Module 2: Factors that influence stability testing
  • Module 3: Stability test requirements
  • Module 4: Bracketing and matrixing
  • Module 5: Shelf life and extrapolation - Challenges
  • Module 6: Impact of changes on stability
  • Module 7: Challenges for biotechnological products


Who should attend
This e-Learning programme addresses the needs of those working in the pharmaceutical industry. It will particularly benefit those needing a good understanding of the requirements, data and challenges of stability testing.

Aims and objectives

This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.
This e-Learning will provide you with:

  • knowledge of regulatory frameworks in Europe, the ICH region and the US;
  • an understanding of the chemical, physical and microbiological factors influencing stability testing, as well as container closure systems and the transportation;
  • in-depth knowledge of stability study requirements;
  • the ability to apply bracketing and matrixing;
  • knowledge of the data needed for extrapolation and defining the shelf life of a product;
  • an understanding of the impact of changes on stability; and
  • knowledge of the stability specifics of biological products.
This e-Learning was developed in January 2018.

Your benefit

The e-learning format allows you to create your own schedule, pause and rewind the video at any time, and avoid being pressed for time. You will benefit from the long-term experience of the expert Dr Beatrix Metzner and gain a good overview on the important aspects that concern the challenges of stability testing in practice. Feel free to pose questions while completing each single or after having completed all seven videos.

Programm

Modul 1 Regulatory requirements (approx. 10 minutes)
  • ICH guidelines
  • WHO guidelines
  • Additional stability guidance documents
After having passed this module you know the regulatory requirements on stability testing by ICH, WHO and other specific guidelines.

Modul 2 Factors that influence stability testing (approx. 10 minutes)
  • Climatic zones
  • 'Quality by Design' - Influencing factors
  • Stability studies - Possible changes
  • Container closure - Impermeable vs semipermeable
  • Transport
  • End user
After having passed this module you have a deep understanding of how climatic conditions, product parameters, changes, container closure systems and the end user can influence the stability testing.

Modul 3 Stability test requirements (approx. 15 minutes)
  • Long-term, accelerated, stress testing
  • Photostability
  • In-use stability
  • Stability throughout life cycle
After having passed this module you know which tests and test-paramenters are required and you have received tips from practice.

Modul 4 Bracketing and matrixing (approx. 10 minutes)
  • Designs
  • Bracketing
  • Matrixing
After having passed this module you can define bracketing and matrixing and have received examples to the designs.

Modul 5 Shelf-life and extrapolation - challenges (approx. 10 minutes)
  • Definition of the shelf life
  • Data required
  • Extrapolation
  • Text conditions
  • Post approval
After having passed this module you can define shelf-life and have an understanding of the necessary data and the extrapolation-requirements.

Modul 6 Impact of changes on the stability (approx. 10 minutes)
  • Relevant guidelines
  • Kinds of changes
  • Stability-indicating parameters
  • Examples
After having passed this module you are familiar with the regulatory background and have deepened your understanding of different kinds of changes and their influence on the stability.

Modul 7 Challenges for biotechnological products (approx. 15 minutes)
  • Relevant guidelines
  • Challenges
  • Batch selection
  • Forced degradation studies
  • Extrapolation
  • Additional challenges
After having passed this module you know the specific regulatory stability-requirements of biotechnological products in contrast to chemicals.

Trailer

e-Learning: Stability Testing in the ICH Region

Here you can get a brief insight into the e-Learning Stability Testing in the ICH Region.

Principles

Principles

The e-learning programme 'Stability testing in the ICH-region' comprises seven didactic modules that include videos in which the expert Dr Beatrix Metzner shares her expertise with you (each about 10-15 minutes duration time). You can also download and print the corresponding presentation documents. Each module comprises additional documents (links, guideline texts, etc.) as well as interactive exercises and questions, which help you practise and apply your newly gained knowledge. Each module ends with an online-test. Once you have completed the seven modules and passed all the tests, you will be awarded a certificate, which you can print out directly.The e-learning programme should be completed within three months. Try our e-learning programme for free and familiarise yourself with our learning environment.

How does it work?

1. Register for an e-learning programme on our website. 2. You will receive an email with your login data for our learning platform. 3. Log in to start your e-learning programme. 4. Complete your e-learning modules at your own pace. 5. Finalise the modules with a multiple-choice test. 6. Once you have successfully completed the test, you will be awarded a certificate, which you can print out. Please try out the demo versions of our e-learning programmes free of charge to get an idea of our learning environment.

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Modules

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