50th anniversary of GMP - How U.S. FDA has celebrated the Kefauver Harris Amendments (and themselves): youtube.com/watch?v=B9u424…

NEU in Kraft ab 2013-01-02: § 52 c AMG - AM-Broker dürfen Tätigkeit erst nach Anzeige bei zuständiger Behörde und Registrierung aufnehmen.

#India is a major source of food and drugs for the U.S. Two #FDA India offices ensure products are safe: go.usa.gov/gJTP.

Liste der zugelassenen Orphan Drugs um ein Präparat erweitert. Jetzt 67 Medikamente gegen seltene Erkrankungen in EU: vfa.de/de/arzneimitte…

We now have a web client available for all electronic applications for human medicines #eSubmission: bit.ly/Xb7USy

We've published guidance for companies on how to prepare and review summaries of product characteristics (#SmPCs): bit.ly/YiVNJo

We've put in place a framework for close collaboration with #Israel: bit.ly/V1pA2S

GMP News: Revision of the EU GMP Guide: EU Commission Publishes Proposals for Chapters 3, 5, 6 and 8 gmp-compliance.org/ecanl_0_0_news…

Neue EU GDP-Leitlinien auch auf Deutsch: eur-lex.europa.eu/LexUriServ/Lex…

Fecc congress aim to drive innovation lnkd.in/EMSA_h

If you are keen to know what we have to face during to audits, you should read the new quarterly column of our boss: bit.ly/1tGzRTS

One week left to comment on draft pharmacopoeial texts bit.ly/1mgMbKX #Pheur #european #pharmacopoeia #pharmeuropa

We've published an @ICH_news #guideline on assessment and control of DNA reactive impurities in medicines: bit.ly/1sXtp9e

Gender equality is not a women's issue, it's a human rights issue. HeForShe bit.ly/1r1V2jA

Die 'Blaue Hand' - ein neues Logo kennzeichnet von BfArM und/oder PEI genehmigtes Schulungsmaterial bfarm.de/SharedDocs/Dow… #GVP #IB

Despite #Trump: Major step towards real #MRA between U.S. FDA and Erin-News: ema.europa.eu/ema/index.jsp?…

Intetesting blog from the MHRA: Do wholesale distributors require pharmacovigilance agreements? mhrainspectorate.blog.gov.uk/2017/07/25/do-… Consider carefully!

23 cities offer to host UK-based EU agencies europa.eu/!Jm98Kt

Passwort-Pionier ist's peinlich: AY-37!?XL* - Sorry für den Wahnsinn | tagesschau.de tagesschau.de/ausland/passwo…