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| Begins |
September 21, 2009
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| Category |
Science: Technology
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| Category 2 |
Health: Medicine
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| Category 3 |
Health: Pharmacy
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| Contact |
Adalbertstr. 9
16548 Glienicke / Berlin
Germany
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| Description |
European regulators agreed to dedicate a Discussion Forum to practical questions about implementation of RMMs as the process seems not well understood. It appears that
- Implementing Rapid Microbiology Methods (RMMs) is a complex regulatory scenario.
- It can become very costly, if Variations to Marketing Authorisations (MAs) are involved.
- Also, the time horizon to get approval for implementation might be unpredictable, especially if the product or products concerned possess heterogeneous MAs.
- 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.
The meeting will develop around questions put forward but not limited to the following topics:
- Variations and Rapid Microbiology Methods
- Scientific Advice
- Issues on Validation, Transition, Use and Documentation of RMMs
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.
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