E-Mobility Reinvented

Key takeaways

  • How to apply ASA to predict your product stability
  • How to improve the stability by picking the right excipient
  • Degradation of biologics by chemical, physical and microbiological factors
  • Bracketing and matrixing to improve your product stability


  • About guidance and expectations for product stability protocol
  • To identify proper analytical methods for stability assessment
  • How to find the correct packaging for biologics with low stability
  • About acceptation of reduced stability data for new formulations


  • A comprehensive overview on stability and shelf-life regulatory landscape
  • Harmonized ICH stability guidelines: Q1a-F and Q5C
  • Requirements for stability testing in Climatic Zones i-iV
  • A contact with key leaders and regulatory authority to build up your network

Training Features

  • Interactive way through stimulation of discussions and giving the participants an opportunity to advance their ideas.
  • Individual case by case consultancy with the trainers
  • All delegates will receive comprehensive course documentation
  • Certificate of Completion issued by the Trainers
  • 5H+ of networking with other industry experts
  • Case studies from the trainer’s experience

Start Time

9:00 am

September 20, 2018

Finish Time

5:00 pm

September 21, 2018


Cologne, Germany

Our Facilitator