Pharmaceutical reference standards play a vital role in the development and production of medicines and are essential for their quality control. This symposium will bring together stakeholders involved in the manufacture, characterisation and use of reference standards to exchange their views and opinions on the different issues related to the subject.
The programme will cover the use and establishment of reference standards, including reference standards for new and complex biologicals and small molecules, and regulatory expectations and harmonisation across the regions.
The symposium will have a particular focus on compendial standards, their intended use and the expectations of users and stakeholders. It will also review recent developments and examine possible solutions to the challenges associated with specific areas such as impurities, antibiotics, microbiological assays, gene therapy products and botanical standards. In addition, the content of various Ph. Eur. and USP chapters and their application using real-life case studies will be presented.
Participants will have a unique opportunity to interact with key stakeholders and organisations from around the world that are involved in reference standard development, manufacture, distribution and use. Each session will be followed by a discussion where participants can ask questions and talk issues over with the presenters.
Who should attend?
This symposium should be of interest to professionals from the pharmaceutical industry, regulatory agencies, medicines control laboratories and academic institutions.