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 authorized ... More

HORN Pharmaceutical Consulting
CMC – GMP – Regulatory Affairs
Dr. Hiltrud Horn
Am Alten Schloß 1
D-76646 Bruchsal
Germany

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Fax: +49 (0) 7251/305 528
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e-mail: info@horn-pharma.de
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29.08.2019
Frankfurt: Prozessvalidierung - Aktuelle Anforderungen für CMC
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17.-18.09.2019
Copenhagen: Drug Master File Procedures in the EU, the US and Japan
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27.09.2019
Frankfurt: Regulatorische Anforderungen an Primärpackmittel
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10.03.2017
News for the Industry
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26.07.2013
News on Change Control/Variations:
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31.01.2013
EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
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