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

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

Company Industries Consulting Project Management GXP Training Information Imprint Privacy Policy
© 2022 Horn Pharmaceutical Consulting, produced by ISI

Home Contact Imprint

HOTLINE

+49 (0) 7251/305 529
Fax

+49 (0) 7251/305 528
Mail

20.-21.06.2022
Online Seminar: Der Regulatory Affairs Manager
More
23.-24.06.2022
Online Seminar: APIs in Regulatory Affairs
More
25.08.2022
Online Seminar: Prozessvalidierung - Aktuelle Anforderungen an CMC-Daten
More

Get all events

16.05.2022
New Clinical Trials Regulation and new IMPD-Guidelines in place
More
29.10.2020
Latest Guidances regarding Nitrosamine Impurities
More
18.05.2020
Impact of COVID-19 pandemic on Pharma: GMP and Regulatory Flexibility
More