Royal Pharmaceutical Society: Stabili...
Home  »  Community News  »  Royal Pharmaceutical...
May
31
sandeepsd
Royal Pharmaceutical Society: Stability Testing of Pharmaceuticals
Upcoming Events & Interviews
0
, ,

Date: 15 – 17th June 2015

Venue: Holiday Inn – Reagent’s Park London

Join us on our annual residential course designed to provide participants with a detailed appraisal of the rationale and techniques associated with the stability testing of pharmaceuticals and related products.

This course is suitable for specialists involved in stability testing of pharmaceuticals, formulation or analytical scientists, those working in regulatory affairs or recent graduates working in an R&D environment.

Delegates will:

  • Be introduced to the physiochemical basis of stability and learn how to predict and mitigate stability issues;
  • See Accelerated Stability Assessment Programme (ASAP) based stability prediction in action through real life scenarios;
  • Learn about the essential steps in the development of clinical and registration stability testing protocols through practical examples;
  • Learn how to maximise the approvability of your stability data, including appropriate statistical strategies;
  • Discuss the guidelines for stability testing within the EU, Japan and US, introduced through the International Conference on Harmonisation (ICH);
  • Gain a broad understanding of the stability “lifecycle” from development through to post approval and learn about aspects of stability testing, including:
    – the criteria for product stability
    – the challenges associated with specific product types, including biotechnology products/devices
    – the application of statistical tools for stability assessment
    – the design, application and limitations of stability test procedures

There will be Q&As, interactive workshops and problem solving sessions with industry and regulatory experts where you will be able to discuss problems encountered in your day-to-day practice. There will also be opportunities for networking with peers.



Leave a reply

You must be logged in to post a comment.