Venue: EDQM Premises, 7 allée Kastner, 67081 Strasbourg, France
Working language: English
The EDQM’s International Symposium on Microbiology will cover recent developments and future changes to the European Pharmacopoeia (Ph. Eur.) in the field of microbiology.
The first part of the Symposium will be devoted to the requirements, development and validation of sterilisation methods and related Biological Indicators (BIs). Participants will learn about the revised Ph. Eur. chapters entitled Methods of preparation of sterile products (5.1.1) and Biological indicators and related microbial preparations used in the manufacture of sterile products (5.1.2).
Focus will be given to:
- the main changes in these revised chapters and their impact on microbiological control
- the implementation of sterilisation processes for medicinal products: validation and practical issues
- role of biological indicators in sterilisation validation
The second part of the Symposium will cover Rapid Microbiology Methods. Participants will learn about:
- the new structure and content of the revised Ph. Eur. chapter Alternative methods for control of microbiological quality (5.1.6)
- the regulatory framework
- validation of Rapid Microbiology Methods (RMMs) and the role of statistics, with specific sessions on validation of RMMs for the control of cell therapeutic products and microbiological control of pharmaceutical water
- new trends and perspectives
During these two days Symposium, participants will have the opportunity to listen to presentations and meet the specialists involved in the elaboration of these Ph. Eur. chapters.
Participants are invited to attend a social event taking place at the end of the first day on the EDQM premises. This will be a great opportunity to share experiences with other participants.
Download the detailed programme.
During the Symposium, a poster session will be organised on the topics covered.
A call for the submission of abstracts to be selected for a poster is open until 30th June. Please note that abstracts can only be taken into consideration if the author or a presenter is attending the Symposium.
For more information, please find:
- Instructions for abstract submission
- Poster abstract submission form (to fill in and return by 30 June 2017)
Send Us Your Questions in Advance
If you would like to submit a question or a topic of interest related to microbiology ahead of the event, please complete the Question Form and send it to the EDQM.
Who should attend?
The EDQM’s International Symposium on Microbiology is of interest to staff members of national regulatory bodies and scientists involved in the development, manufacturing, quality control, quality assurance and licensing of medicinal products.