Pharma

Training Courses | ClassroomTraining

Stability & Shelf Life of Biologics

Days

Hours

Minutes

Seconds

Stability & Shelf Life of Biologics

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

meet the training leaders

Dr. Jörg Engelbergs

Paul Ehrlich Institute (PEI), Germany

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Dr. Robert E. Zoubek

Executive Consultant

Granzer Regulatory Consulting & Services, Germany

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training

Brochure

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

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
- Contact with key leaders and regulatory authority to build up your network

Testimonials

This training was exactly what I needed. It covered all aspects of stability studies: what is needed, which method use, how to set a shelf-life, how to extrapolate... The regulatory part is very interesting. I learnt a lot and strongly recommend this masterclass!

Registration

Training tickets

Delegate Fee

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2396€

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Online Live Stream

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1396€

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Contact us

Andrea Weber

Sr. Manager for Pharma

Phone: +421 257 272 100

Email: event.inquiries@fleming.events

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Stability & Shelf Life of Biologics

Stability & Shelf Life of Biologics