One Response to “New Newsgroup on Drug Regulations”

1. admin says:

   January 29, 2010 at 3:24 pm

   - Hide quoted text — Show quoted text -

   Les Thomas <ltho…@sirius.com> wrote:
   

   >Please note that new group has been formed to discuss subjects related to
   >the regulation of drugs, biologics and medical devices.  This group
   ><alt.pharm.reg-affairs> has been created to enhance the dissemination of
   >information concerning the regulation of pharmaceutical products by
   >various government agencies – such as the US Food and Drug Administration
   >(FDA), The European Agency for the Evaluation of Medicinal Products
   >(EMEA), and the Japanese Ministry of Health and Welfare (MHW).  While
   >this group was formed by regulatory professionals primarily for the use
   >by others in industry and government, the general public is welcome to
   >post questions in this forum.

   >–
   >Les Thomas
   >XOMA Corporation – Department of Regulatory Affairs
   >ltho…@sirius.com

   Les,

   Great to hear something like this has been set up. I don’t have it yet
   on my service providers newsfeed but i’m sure I will soon.

   I am in Regulatory with Zeneca pharmaceuticals myself and am finding
   the Internet incresingly useful in my job – especially with EMEA
   coming on board with a Web presence and beginning to post public
   assessment reports for drugs which have gone through the new
   centralised filing procedure there.

   Things which I would be keen to hear people’s views on are:

   1) Where is ICH inititaive on electronic data transfers going

   2) Hypertext as a new authoring adjunct and good style re its use in
   electronic submissions

   3) Acobat PDF vs SGML vs HTML as a common currency for exchange of
   electronic regulatory documentation

   4) electronic doc mgt systems, opinions Documentum vs others
   Ricky Bache, Macclesfield, Cheshire
   England
   E Mail: bac…@dircon.co.uk