In This Edition
|9/14/2009 - 8:00AM
||2009 PDA/FDA Joint Conference - Washington DC
|10/13/2009 - 8:00AM
|PDA/EMEA Joint Conference - Berlin, Germany
Counterfeit, Rogue or Contaminated; No Matter What You Call It, It’s About Putting Patient Safety First
The date is 16 April 1998. Five regulatory affairs experts from five different European API manufacturing companies gather in a meeting room in Delft, The Netherlands. They have called themselves “The APIC Counterfeit Task Force” and have no idea yet that this meeting will be the very first step on an extremely long journey during which a lot will be learned…
By Chris Oldenhof, DSM; President of APIC; Board member of EFCG
The Parliament Magazine Special Issue on “Fake Medicines” Makes Case for Strong EC Legislation
By Lewis T. Kontnik, Director, Amgen Brand Protection
This fall the European Parliament and Council of Ministers will consider the European Commission (EC) proposal for a directive on “Falsified Medicines.” A special issue of The Parliament Magazine, Summer 2009, on “Fake Medicines—Tackling the threat to patients” provides a wealth of support for adoption and strengthening of these proposed measures.
News Flash – 16 June 2009
Drugs and biologics are no longer the subject of Rep. Dingell’s active “import safety” bill
HR 759 (introduced on 28-January-2009) was US Congressman Dingell’s draft safety bill pertaining to food, drugs/biologics, devices and cosmetics (the “FDA Globalization Act of 2009” or “FDAGA”). That bill is no longer active, and has been replaced with a new bill HR 2749.
Update: Rx-360 has learned that Congressman Dingell is working on a separate piece of legislation for drugs.
News Flash - 17 June 2009
Rx-360 Launch Meeting Presentations Available to View and Download
The presentations from the Rx-360 Launch Meeting are now available to view and download from the Rx-360 website at www.Rx-360.org. Additionally, the results of the real-time polling conducted with attendees at the meeting are now available in the registered section of www.Rx-360.org.
News Flash – 10 June 2009
Official Launch of Rx-360 is a Success
On Friday June 5, 2009, over 125 representatives from across pharmaceutical, biotech, and generic drug manufacturing industries, along with their suppliers, professional trade associations and regulatory agencies, came together in Washington, D.C. to officially launch the non-profit international supply chain and quality consortium, Rx-360.
Get Involved Today! Become a Member
Rx-360 recently achieved a major milestone and is now incorporated as a nonprofit.
To become a member, click here and download the membership documents.
For more information, email: info@Rx-360.org.