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Stability & Shelf Life of Biologics

This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.

  • Dates – not available
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Online Live Stream

Stability & Shelf Life of Biologics

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Training features

Interactive discussions and Q&A sessions
Individual discussion & consultancy with the trainer
Case studies from the trainer's experience

Certificate of completion issued by the trainer

Comprehensive course documentation
Fully online

All sessions of this unique course online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

meet the training leaders
Joerg Engelbergs | Fleming
Linkedin
Dr. Jörg Engelbergs
Regulatory-Scientific Expert and Assessor
Paul-Ehrlich-Institute, PEI
View trainer bio
Robert Zoubek | Fleming
Linkedin
Dr. Robert E. Zoubek
Executive Consultant
Granzer Regulatory Consulting & Services, Germany
View trainer bio
training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

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Stability & Shelf Life of Biologics online live training organized by Fleming_Agenda Cover
Stability & Shelf Life of Biologics online live training organized by Fleming_Agenda Cover
Stability & Shelf Life of Biologics online live training organized by Fleming_Agenda Cover
key training

Topics

Guidance and regulation for stability of biologics with focus on biotech products

Advantages and limitations of accelerated and stress stability assessment

Biologics degradation by chemical, physical and microbiological factors

Biochemical and kinetic approaches to product stability

Analytical methodology for stability assessment

The role of excipients in stability of biologics

Transport and shipping impact on stability and shelf-life

Benefits of attending

  • Understand

    • How to apply accelerated and stress stability assessment to support your filing
    • How to improve the stability by picking the right excipient
    • Degradation of biologics by chemical, physical and microbiological factors
    • Bracketing and matrixing to cover your product stability

  • Learn

    • About guidance and regulatory expectations for product stability protocol
    • To identify proper analytical methods for stability assessment
    • What to consider for the correct packaging for biologics
    • About acceptation of reduced stability data for new formulations

  • Gain

    • A comprehensive overview on stability and shelf-life regulatory landscape
    • Harmonized ICH stability guidelines: Q1A-F and Q5C
    • Requirements for stability testing for biologics for clinical development and MAA
    • A contact with key leaders and regulatory authority to build up your network
Registration

Training tickets

This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.

Online Live Stream
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1596€
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Delegate Fee
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2396€
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Contact us

Andrea Weber | Marketing Manager | Fleming
Linkedin
Andrea Weber
Sr. Manager for Pharma
Phone: +421 257 272 100
Email: event.inquiries@fleming.events

Put me on the waiting list

DOWNLOAD THE BROCHURE AND REVEAL THE FULL PROGRAM DETAILS

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