News 2021

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

Phone: +49 (0) 7251/305 527
Fax: +49 (0) 7251/305 528
Mobile: +49 (0) 160/5834 213
e-mail: info@horn-pharma.de
Internet: www.horn-pharma.de

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Events

09.-10.02.2021
Live Online Seminar: GMP-gerechter Prozess-Transfer
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16.-17.03.2021
Live Online Training: Annex 2 & Co - GMP Compliance for Biopharmaceuticals
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14.-15.04.21
Live Online Training: Handling Changes and Variations
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News

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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EU: New Variation System in force as of Jan 1, 2010. Filing of variations will be faster, easier, and more flexible. Have you considered that your Change Control System needs to be updated accordingly?

EU: Centralised Marketing Authorisation Procedure for ATMPs needed Have you already filed your application? The time clock is ticking. Transitional periods will be over soon.