News 2010

11.03.2010
EU: IMPD requirements for the Quality part of biological/biotechnology derived substances defined
- Draft out for comments until Aug. 31, 2010 - On March 11, 2010 the European Medicines Agency published the draft guideline on the requirements for quality documentation concerning biological ... More
19.04.2010
EU: GMP-Annex 2 revised - Details defined for biological products including ATMPs
- Draft out for comments until July 15, 2010 - On April 19, 2010 the European Commission published the revised draft of GMP Annex 2: Manufacture of Biological Medicinal Substances and ... 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
© 2024 Horn Pharmaceutical Consulting, produced by ISI

Home Contact Imprint

HOTLINE

+49 (0) 7251/305 529
Fax

+49 (0) 7251/305 528
Mail

Get all events