- email:registration@pti-europe.co.uk
- phone:+44 (0) 20 7017 7481
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An Introduction to Immunogenicity
5 - 6 November 2013 , Radisson Blu Edwardian Grafton
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TAUGHT SESSIONS
This 2-day course shows you how to detect, reduce and characterise unwanted immunogenicityINTERACTIVE TASKS
Discuss the advantages/disadvantages of various assay platforms used to detect and characterise unwanted immunogenicityCASE STUDIES
...and interactive sessions to provide hands-on experiencePRACTICAL EXERCISES
Assay development – practical aspects using ELISA as an example
An Introduction to Immunogenicity
Course Objectives
Early detection of immunogenicity reactions is a key component of a drug development programme.
This 2-day course shows you how to detect, reduce and characterise unwanted immunogenicity, interpret the latest EMA and FDA regulatory guidelines and formulate a winning strategy that you can implement into your business immediately.
Most of the sessions comprise a formal presentation followed by facilitated break-out groups where delegates will be given the opportunity to apply some of the principles from the taught sections. The break-out sessions will be fully supported with background documentation and experts will be available to facilitate and guide the groups during these sessions.
What Will You Learn?
Dates and Venues
05 Nov 2013 - 06 Nov 2013
Radisson Blu Edwardian Grafton
Critical steps to detect and characterise unwanted immunogenicity
- Understand the basic principles behind immunogenicity
- Detect, minimise, and identify the root cause of protein immunogenicity as early as possible
- Discuss the advantages/disadvantages of various assay platforms used to detect and characterise unwanted immunogenicity
- Appreciate the impact of immunogenicity on PK, efficacy, and safety
- Interpret the latest EU and US regulatory guidelines
- Discover successful strategies for validating immunogenicity assays for both pre-clinical and clinicalstudies
- Incorporate neutralising antibody assays into your overall immunogenicity assay programme
Who Should Attend?
Those working in:
• Biotech R&D Staff
• Bioanalytical Scientists
• Clinical Research Associates
• Validation Specialists
• Project Management
• Regulatory Affairs
• QA/QC
Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals
