The European Medicines Agency has published a

Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells Draft (EMA/CHMP/GTWP/671639/2008)

Please use the Template for your comments and provide them to 

 jan.doran(at)roche.com by 15 September 2010

The European Medicines Agency has published a

Draft guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture (EMA/CHMP/BWP/68803/2010).

Please use the Template for your comments and provide them to 

 jan.doran(at)roche.com by 10 August 2010

The European Medicines Agency has published a

draft Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA

Draft 26 May 2010 EMA/7123 European Medicines Agency Working Group on Third Country Clinical Trials

Please use the Submission of Comments Template and provide them to

 jan.doran(at)roche.com by 15 August 2010

The European Medicines Agency has published a

Submission of comments on 'Guideline on Validation of Bioanalytical Methods' (EMA/CHMP/EWP/192217/2009)

Comments from European Quality Assurance Confederation (EQAC)

GUIDANCE DOCUMENT

Non Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice

Health Canada has announced the release for the 30 April 2010

This guidance applies to all sponsors who submit non-clinical study data from a Clinical Trial Application (CTA), CTA Amendment (CTA-A), Drug Identification Number (DIN) Application and applications to support a post-DIN change, New Drug Submission (NDS), Abbreviated New Drug Submission (ANDS) and submissions to support a post-Notice of Compliance (Post-NOC) change, that is, Supplement to an NDS (SNDS), Supplement to an ANDS (SANDS), and Notifiable Change (NC). Non-clinical studies include all in vitro and in vivo testing, not involving human subjects, performed to determine the safety of human drugs .

Questions and Answers to: Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice

Link to the website:

http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201004&RIN=0910-AG47

SPAQA Vorstand

Liebe Mitglieder und Nicht-Mitglieder, wir freuen uns ihnen mitteilen zu können, dass es seit dem 4. Mai 2010 einen neu zusammengesetzten Vorstand gibt.

FDA Issues Proposed Rulemaking Impacting Sponsors

The proposed rule would require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor.

http://edocket.access.gpo.gov/2010/2010-3123.htm

Fragen & Antworten Behördendiskussionsrunde 2009

Die Fragen & Antworten der Behördendiskussionsrunde 2009 sind unter Downloads/Behörden Diskussionsrunde 2009 verfügbar.

FDA Warning Letter wegen Verstösse gegen GLP

FDA's Center for Biologics Evaluation and Research versendete am 17. August 2009 einen Warning Letter wegen zahlreicher Verstösse gegen die GLP-Vorschriften im Code of Federal Regulations. 
FDA Warning Letter (GLP) 17-Aug-2009