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12 - 13 September 2017
Clarion Congress Hotel,

Improving Reliability and Efficiency of Product Analysis and Stability Testing Through New Analytical Methods and Technology

Thank you to everyone who attended this year's Analytical Summit


We would like to extend a very big thank you to everyone who attended this year's Analytical Summit. In the heart of Berlin, analytical experts gathered to discuss the latest developments for analytical methods and stability testing. 

Stability Testing for Pharmaceuticals and Biologics delved into global stability protocols, the latest approaches for shelf-life prediction, regulatory acceptance of risk based assessments and QbD, best practices for conducting extractable and leachable testing, working towards improved efficiency throughout the product lifecycle and lots more.

Analytical Method Developments, Validation and Transfer gave valuable insight into the most appropriate approaches to continuous performance monitoring from a lifecycle management perspective, practical applications of the ICH Q3D guideline on elemental impurities, the integration of software into analytical method development and alternatives to HPLC methods, Regulatory Authority guidance on AQbD (MHRA) and the FDA CDER/CBER Guidancewith (FDA). 

It was great seeing so many familiar faces, as well as meeting lots of new ones. 

Mark your calendar - The dates for our 2017 meeting have been released and we are delighted to announce that next year we will be in Prague at the Clarion Congress Hotel on 12-13 September 2017. We look forward to seeing you there.

Implementation Strategies Across All Aspects of Stability Testing and Analytical Method Development, Validation and Transfer

Stability Testing for Pharmaceuticals and Biologics
  • Global stability protocols - how are companies overcoming country specific requirements?
  • What are the latest approaches for predicting shelf-life in early phase development, authority accepted models and application of ASAP?
  • Regulatory acceptance of risk based assessments - can QbD and analytical methods reduce costs and timeframes?
  • Stability studies throughout the product lifecycle - what are company strategies for effective change control management?
  • What are the best practices to successfully conduct extractable and leachable testing?
Analytical Method Development, Validation and Transfer
  • MHRA guidance on AQbD - how can enhanced approaches be applied to compendial methods?
  • FDA feedback - what are the key take home messages from the FDA CDER/CBER Guidance?
  • Continuous performance monitoring from a lifecycle management perspective - what are the best strategies?
  • What are the practical applications of ICH Q3D Guideline on elemental impurities?
  • How are companies integrating software into analytical method development?
  • Non-HPLC methods - what alternative techniques are companies using?
All Access at No Additional Cost to Other Events at the Analytical Summit

Aside from stability testing and analytical method development, benefit from additional learning opportunities in the same venue, on the same dates:

Network with 350+ analytical, quality and formulation decision makers

Companies from the Pharmaceutical and Biopharmaceutical Industries
Top Global Pharmaceutical Companies

Analyse, Interpret, Improve

Knowledge Exchange
  • Thought Leaders Discussion Panels 
  • Interactive Flash Presentations
  • Case Studies and Roundtable Discussions on Complex Products including Biologics, Inhaled and Combination Products
  • Live Labs Tour
  • Ask the Experts: Pain Points Discussions
Peer to Peer Networking & Partnering Opportunities
  • Event App: Browse the delegate list, access speaker presentations, set up 1-to-1 meetings, view the latest agenda and vote on industry hot topics 
  • Drinks Reception and Social Evening
  • Informa Treasure Hunt
  • 5 Conferences in 1 Location

Associate Sponsor

Pharmaceutical Training International | PTI

PTI is a global interactive training partner committed to the personal progression of aspiring life science professionals. We deliver CPD certified training on a wide range of topics including R&D, pre-clinical, clinical, manufacturing, regulatory affairs, pharmacovigilance, biotech, business strategy and soft skills. Our courses are delivered in a variety of formats such as public face-to-face, customised in-house, webinars, eBooks and online academies.