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Forced Degradation 18-19 January 2012

Don’t miss Europe’s only dedicated stress testing event! Plus in 2012 we have co-located Forced Degradation for Pharmaceuticals with Forced Degradation for Biologics to allow you the unique opportunity to meet and network with colleagues working in large molecules and share common experiences.


Featuring authors from the new Pharmaceutical Stress Testing: Predicting Drug Degradation, second edition, we bring you key industry thought-leaders, including speakers from Pfizer, Eli Lilly, Merck, GSK and AstraZeneca.

Addressing current topics and recent developments in the field, featured sessions include:

  • Reviewing advances in knowledge of drug degradation chemistry and pathways
  • Assessing the similarities and differences in developing a forced degradation strategy for large and small molecules
  • Applying genotoxic impurity guidelines to forced degradation studies
  • Application of forced degradation studies in drug discovery and sharing lessons learnt
  • Case studies in optimizing physical and chemical stability to ensure drug product performance
  • Drug Substance Degradation Studies
  • Drug Product Degradation
  • Assessing the predictive nature of compatibility studies and effect of excipients on degradation pathways to optimise formulation development

 

Who You Will Meet...

Who You Will Meet...

David Elder Product Development Director GlaxoSmithKline

Axel Becker Scientist, Central Analytical Services Department Merck KGaA, Germany

Karen Alsante Research Fellow Pfizer, USA

Harm Niederländer Bio-Analytical Project Leader, Synthon Netherlands

Carsten Worsøe Principal Scientist Novo Nordisk A/S

Markus Zimmer Head of Analytical Development Unit Sanofi-Aventis



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NEW for 2012! Pre-conference workshop

Best practices in analytical method development for forced degradation studies
Led by: Harm Niederländer, Bio-Analytical Project Leader, Synthon, The Netherlands

Selection of techniques and methodology, including:

  • Defining endpoints in assessment of the impurity profile, including:
  • Setting up studies to be timely and cost effective, as well as comprehensive and predictive
  • Feeling confident with automated data processing and interpretation of results
  • Judging results from sample testing for representativeness under real-world conditions (over - and under estimation)

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Not to be missed! Discussion of ASAP!

Using scientific methods to predict shelf-life
Led by: Ken Waterman, Research Follow, Pfizer, USA 

  • Forced degradation studies as a tool for setting stability-indicating methods
  • Accelerated Stability Assessment Programme (ASAP)
  • Feedback from the stability department

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Exclusive for 2012

Forced Degradation for Pharmaceuticals will be co-located with Forced Degradation for Biologics. For more details visit www.informa-ls.com/forceddegbio

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Dates and Venues

18 Jan 2012 - 19 Jan 2012

etc venues - Dexter House, London, UK

Reviews

"Covers the major topic related to forced degradation studies"
Chesi Pharmaceutica
"Good content, knowledgeable speakers, good discussions, excellent networking opportunity (Baertschi, Lilly)"
Eli Lilly
"The focus on forced degradation provided the focal point for sharing knowledge. Outstanding"
RAI

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