Tuesday, 8 December 2009

EMEA and FDA strengthen collaboration on inspections

The FDA (US) and the EMEA (EU) have started a Bilateral GCP Initiative as of September 1st, 2009. This program has been enabled by confidentiality arrangements between the EU and the FDA which deals with GCP-related information contained in applications for scientific advice, orphan medicines designation, pediatric investigational plans and marketing authorisation or postauthorisation activities of significant public health interest.

The intention of this Joint Inspection Program is that it will help to protect clinical trial subjects in the growing globalisation of clinical research. Most of the time, the same trials are used for Marketing Authorisation Applications (MAA) both in the US and in the EU. This initiative intents to ensure that those trials are executed uniformly, appropriately and ethically.

It concerns a pilot phase of 18 months, after which a joint assessment will lead to modifications and amendments to the scope and process, as needed.

The key objectives are:
 - To conduct periodic information exchanges on GCP-related information
 - To conduct collaborative GCP inspections
 - To share information on interpretation of GCP

The two regulators are currently inviting companies who are planning to submit applications fairly simultaneously to both regulatory authorities between September 2009 and September 2010, to volunteer to partner in this pilot. wow gold

Tuesday, 10 November 2009

FDA 1572's continued use, though expired

The FDA 1572 form has an official Expiration Date: May 31, 2009. Almost 6 months ago!

However the FDA is reporting on their website that "FDA has OMB approval to use the form until 8/31/2011".

This means that the form will not be updated, it will continue to be used in it's current form, sporting the current expired expiration date, until end of summer 2011.

Though being an FDA, therefore US form, this form is widely used outside of the US, even though, by signing it, non-US investigators are agreeing to work in accordance with the US Code of Federal Regulations (specifically 21 CFR parts 50, 56, 312.62, 312.64, 312.68 and 312 as a whole).

At audits and inspections, by the way, still often a 2 page version of the 1572 is found, with an original signature. This form needs to be double sided, signature on the back, not enabling changes to the details on the front without having to sign again. In May 2010, the FDA stated that either a double sided 1572 or a two-page document "is acceptable; however, FDA recommends that a two-page document be stapled so that there is no question about what form the investigator signed."
 Any updates warrant a new FDA 1572 to be created, and newly signed and dated.wow gold

Welcome to Clinical Research Weekly!

Today is the birth of this new blog.

This blog is started to share little bits of Clinical Research news on a weekly basis.

Everyone working in Clinical Research (CR) is just too busy to keep up with what's going on in the rest of the world. This blog is the outcome! Just a couple of minutes read every week gets you a bit of news, a reminder, or just an interesting little tidbit.

My name is Eric. I've been working in CR for over 15 years, having done jobs like data manager, CRA, Clinical Team Leader, Clinical Research Trainer, Medical Advisor, etc.

The intention of the writings is to be educational and/or informative.

Please leave comments as you see fit, I'm very open to suggestions or comments.

Welcome, and here's to a successful blog!
Eric wow gold