PDA Discussion Forum: Implementing Rapid Microbiology Methods (PDA Discussion Forum)
Venue: Sheraton Offenbach Hotel
|Event Date/Time: Sep 21, 2009||End Date/Time: Sep 21, 2009|
|Registration Date: Sep 21, 2009|
|Early Registration Date: Aug 21, 2009|
|Abstract Submission Date: Jul 21, 2009|
|Paper Submission Date: Aug 21, 2009|
â€¢ Implementing Rapid Microbiology Methods (RMMs) is a complex regulatory scenario.
â€¢ It can become very costly, if Variations to Marketing Authorisations (MAs) are involved.
â€¢ Also, the time horizon to get approval for implementation might be unpredictable, especially if the product or products concerned possess heterogeneous MAs.
â€¢ Discussions with regulators on scientific and practical questions seem not to be endorsed before a formal application is submitted, leaving the risk of missing aspects crucial to the authorities and related delays to the applicant. In essence the process seems not well understood.
The European regulators agreed to dedicate a Discussion Forum to these very practical questions. The meeting will develop around questions put forward but not limited to the following topics:
â€¢ Variations and Rapid Microbiology Methods: Successful Ways to Implementation and Issues
In this discussion, the regulators are willing to share their views and give examples of what will result in a transparent process, get timely approval as well as how to choose a cost effective strategy. New developments and existing options in the regulatory framework will be explained. Emphasis will be given to regulatory options available and the scientific basis to build on.
â€¢ Scientific Advice
Although FDA offers discussions on â€œcomparability protocolsâ€ to enhance implementing RMMs, such an instrument does not exist in the jurisdiction of the EU. However, Regulators will highlight the regulatory support any interested organisation might be able to get from international as well as national Competent Authorities in Europe.
â€¢ Issues on Validation, Transition, Use and Documentation of RMMs
The focus will be on practical problems to implemented RMMs to enhance and/or substitute conventional Environmental Monitoring, In-Process and Finished Product Testing. It will be discussed how to demonstrate equivalence or superiority to traditional methods employed. Furthermore aspects of transition specifically for level/limit definitions, trending, data evaluation, release decisions and methods to be applied during stability studies or in case of dispute are discussed.
Send Your Questions in Advance
You are encouraged to participate and send in specific questions or issues, to make sure, the regulators can prepare for concise and to the point answers. There are no limitations to the topics to be asked for in the context of RMMs. PDA guarantees anonymity and confidentiality, if case studies or other sensitive data is put forward to be discussed.