WSQMS Homepage

 

Jun 7, 2018

 
US FDA issues Institutional Review Board (IRB) Written Procedures
Final Guidance for Institutions and IRBs effective May 2018

This guidance has been prepared jointly by the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). To enhance human subject protection and reduce regulatory burden, OHRP and FDA have been actively working to harmonize the Agencies’ regulatory requirements and guidance for human subject research. This guidance document was developed as a part of these efforts.

Read more online



USFDA issue new Guidance on Clinical Trial Imaging Endpoint Process Standards
Final Guidance for Industry effective April 2018

The purpose of this guidance is to assist sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of drugs and biological products.2 This guidance focuses on imaging acquisition, display, archiving, and interpretation process standards that we regard as important when imaging is used to assess a trial’s primary endpoint or a component of that endpoint.

Read the pdf



EMA draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice
EMA asks for comments on the new guideline by end of August 2018

The guideline lays down the principles for the two-step release and shipping of the investigational medicinal products by the qualified person and the sponsor. The guideline also describes the areas of interface between the manufacturer and the sponsor and the required contractual agreements.

Read more online



Pediatric investigation plans: questions and answers
Detailed guidance for sponsors applying for a pediatric investigation plan (PIP)

This page provides detailed guidance for companies intending to apply for a pediatric investigation plan (PIP), waiver, deferral or product-specific waiver, as well as for companies that already have an agreed PIP. The information is available as questions and answers, which the European Medicines Agency (EMA) revises as necessary.

Read more online



Informed Consent for Pediatric Clinical Trials in Europe 2015 - Updated
Update from May 2018 detailing procedures in all member states

The working group on Ethics has issued a new version of the document with links to all local sources.

Read the pdf

 

You receive this newsletter, because you have subscribed to it.
If you no longer want to receive this newsletter, you can easily leave the list at this Website.You can't view the images in this e-mail? Click here to open it in your browser.

Widler & Schiemann AG - Weinberghöhe 10 B - CH 6300 Zug, Switzerland - VAT number: CHE-472.215.777 MWST - Public Limited Company according to Swiss Common Law - Managing Partner: Dr. Beat Widler, Dr. Peter Schiemann - +41 41 558 9193 - info@wsqms.com - http://www.wsqms.com