News 2013

31.01.2013
EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
- Deadline for coming into operation: Jan. 31, 2013 - On Sept. 9, 2012 the European Commission published the revised GMP Annex 2: Manufacture of Biological Medicinal Substances and ... More
26.07.2013
News on Change Control/Variations:
New Guidelines applicable as of Aug. 4, 2013 covering updated Classifications and Procedural Aspects The European Variations Regulations were updated and will also apply to nationally ... More

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CMC – GMP – Regulatory Affairs
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03.-04.11.2021
Berlin: How to provide process validation data in regulatory submission
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09.-11.11.2021
Live Online Training: Regulatory Compliance Expert - Arzneimittelzulassung für Mitarbeiter aus dem GMP-Umfeld
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09.-10.11.2021
Live Online Training: Procurement and Purchase meet GMP
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29.10.2020
Latest Guidances regarding Nitrosamine Impurities
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18.05.2020
Impact of COVID-19 pandemic on Pharma: GMP and Regulatory Flexibility
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26.03.2020
New Deadline for Nitrosamine Impurities
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