Leah_Kleylein's blog

The Swiss Health Authority Swissmedic will accept applications in eCTD format starting in January 2010.  They have an announcement for all this on their website, but it doesn't do you much good unless you read German, which sadly, I cannot. 

http://www.swissmedic.ch/aktuell/00003/00870/index.html?lang=en

A step in the right direction.....codes for RPS have been posted on the NCI website.  It's not pretty yet, but it's there.  However, right now, the codes provided are only the table of contents sections for ICH’s Common Technical Document (Modules 2-5) and the US FDA’s regional table of contents (Module 1).

There is a nice brief discussion of what a 483 is (in case you are dying to know) at the path below, along with a link to some suggestions that FDA has put out there on how to respond to one if you get one.

http://www.eyeonfda.com/eye_on_fda/2009/02/fda-presentation-on-responses-to-483s.html

CDER has put out their list for 2009 of planned guidances.  The few that relate directly (or indirectly) to Regulatory Operations are:

Australia has put out some updated guidance and draft guidance on eCTD.  There is now a version 2.1 of the AU Module 1 Specification, and a draft version 1.5 of their guidance on submissions in eCTD format.  Both can be found on the TGA's website, the link is below.  Happy reading!

http://www.tga.gov.au/docs/html/eugctd.htm

Welcome back to work everyone!!!  I hope that you all enjoy a happy and prosperous 2009, we certainly all deserve it I think after that mess of a last year.  Anyway, back to work....

This is my favorite time of year, I admit it. I love Christmas and the holidays, garlands and lights on everything, sugary snacks and liquor abounding.

I thought a good place to start would be introductions. Hi, my name is Leah Kleylein and I work for Octagon Research Solutions, Inc. My role here is Product Strategist for the ViewPoint team. In other words, I am a lonely SME surrounded by oodles of techie people who use incomprehensible acronyms and made-up words. I’m pretty sure they talk about me while I’m in the room, but I just can’t understand them.