Profile cover photo
Profile photo
hjs consulting
1 follower
1 follower
About
hjs consulting's posts

Post has attachment
hjs consulting takes part at the MedPharmPlast Europe Conference 2015; speaker: Dr. Oliver Okle; Endocrine Disruptors: Definitions & Regulatory Thresholds

Post has attachment
hjs consulting

Post has attachment
hjs consulting will take part at the 9th Congress of Turkish Society of Toxicology and Helenic Society of Toxicology (21th - 24th of October 2015)

Post has attachment
hjs diagnostics, eine Abteilung der hjs consulting, ist zuständig für die Sales und Marketing Aktivitäten sowie den Vertrieb der SafeFine Insulin-Pen-Nadelboxen der Firma Pharmadia

Post has attachment
Themen des 12. BioValley Stammtisch Neuenburg:

1. Wirtschaftsfaktor Gesundheit und Life Sciences - von "BioValley" bis "HealthRegion Freiburg".
Referent: Herr Dr. Bernd Dallmann, Hauptgeschäftsführer der Wirtschaftsförderung Region Freiburg e.V.

2. Primäre Barrieren im menschlichen Organismus: Welche Chancen und/oder Probleme entstehen dadurch bei der Medikamentenentwicklung?
Referentin: Frau Dr. Eleonore Haltner, CEO der Firma Across Barriers GmbH

ÖPNV und Parken:Kostenlose Parkplätze sind am Rathaus und in der Umgebung vorhanden

Post has attachment
Genotoxic Impurities – the ICH M7 Guideline
 
The ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) has published the finalized M7 guideline dealing with the determination and the control of DNA reactive (mutagenic) impurities in medicinal products. The guideline is entitled: "Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk". The guideline also offers guidance on analysis of structure activity relationships (SAR) for genotoxicity.
 
The M7 guideline reached step 4. That means the M7 guideline must now be implemented into the national guidelines of the ICH regions (Europe, America, Japan) (step 5). BUT the Ames test, mentioned in the M7 guideline, must be conducted according to M7 with immediate effect.
 
The Ames MPF kit, provide by hjs consulting, can be used for the determination of impurities. The requirement of test substance is 4 times less compared to the traditional Ames test and is therefore the predestinated test system if compound quantity is limited. This miniaturized assay, explicitly mentioned in Note 2 of the M7 guideline, has a proven high concordance.
 
If you have any questions concerning the Ames MPF Kit and its use for the determination of impurities, please do not hesitate to contact use.
 
A specific seminar "Genotoxische Verunreinigungen in Arzneimitteln - Regulatorische Anforderungen und Qualifizierungsstrategie“ will be held in Leipzig, 11th of September 2014.

Post has attachment

Post has attachment
Themen des 12. BioValley Stammtisch Neuenburg:

1. Wirtschaftsfaktor Gesundheit und Life Sciences - von "BioValley" bis "HealthRegion Freiburg".
Referent: Herr Dr. Bernd Dallmann, Hauptgeschäftsführer der Wirtschaftsförderung Region Freiburg e.V.

2. Primäre Barrieren im menschlichen Organismus: Welche Chancen und/oder Probleme entstehen dadurch bei der Medikamentenentwicklung?
Referentin: Frau Dr. Eleonore Haltner, CEO der Firma Across Barriers GmbH

Post has attachment
Das Seminar richtet sich an Mitarbeiter der pharmazeutischen Industrie, insbesonders aus den Bereichen Zulassung, F&E, Qualitätssicherung, Qualitätskontrolle und Analytik sowie von Behörden in Bund und Ländern.
Wait while more posts are being loaded