|
 |
| home > pmps > autumn 2003 > the impact of the eu clinical trials directive on the supply chain |
|
|
 PUBLICATIONS |
Pharmaceutical Manufacturing and Packing Sourcer
|
The European Union is about to enter a new era in the conduct of clinical trials within its jurisdiction. The vastly different range of current approaches from member states to trials are going to converge on 1st May 2004. At least that is the intention. Will we make it on time or will national differences on interpretation make it impossible? Not only that, but how will the new accession countries intending to join the EU in May 2004 fare? In both cases, only time will tell.
This article broadly highlights certain aspects of the changes to clinical supplies as demanded by the Directive (1) and encouraged by the accompanying publication of guidance in the revised Annex 13 (2) to European Good Manufacturing Practice (GMP). Readers may find that these changes already exist in many Member States' legislation, but in most countries the requirements are new.
|
Read full article >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
 |
Industry Events |
 |
Small Scale Biomanufacturing – clinical trials, cell & gene therapies
18 September 2008, Clifton Pavilion, Bristol Zoo Gardens, Bristol
This one day conference, sponsored by bioProcessUK and organised by BioApproaches South West, will cover key, important topics relating to small scale GMP biomanufacturing.
More info >> |
|
 |
News and Press Releases |
 |
Azopharma Announces Plans to Implement XcelodoseTM Technology in the Production of Early Stage Clinical Trial Materials
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today plans to implement Xcelodose technology at its formulations development facility, ApiCross Drug Delivery Technologies. Xcelodose technology is a powder micro-dosing system developed by Meridica. This technology offers a unique powder dispensing system for small-scale capsule filling and ultimately assists in conserving valuable research material as well as reducing various Preformulation activities.
More info >> |
|
 |
