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Control of Medicines: News & General Information

OCABR Human Biologicals

2009 Product Specific Guidelines and Procedures

(11/12/09) The 2009 product specific guidelines and procedures for OCABR are now available to download. For more information, please click HERE.

New publications of General OMCL Network policy documents

During the last Annual Meeting of the General European OMCL Network (GEON), which took place from 25-29 May 2009 at the premises of the “Austrian Food and Drug Agency" (AGES) in Vienna, a number of new documents and revised versions of existing documents have been adopted by the Network.  Amongst others, the following approved revisions of policy documents:  More information.....

Quality Assurance

Validation of Computerised Systems

(07/07/09) New OMCL Network guidelines are now available to download and can be found under our Quality Assurance Activities Guidelines section.

OMCL Annual Seminar 2009

(23/06/09) The EDQM held its 14th Annual Meeting of the Official Medicines Control Laboratory (OMCL) Network in Vienna from 25 to 29 May 2009. This annual conference was organised with the help and support of the Austrian OMCL - Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES) and was held on the AGES premises in Vienna. More information...

Proficiency Testing Studies (PTS)

(17/06/09) In September 2009, the EDQM will propose the first PTS on radiopharmaceuticals, which will consist of a determination of the radiochemical purity by liquid chromatography as described in a monograph of the European Pharmacopoeia. More information.....

Events

 

IABS International Scientific Workshop on Viral Safety, 25-27 October 2009, Annecy, France

More information....

Proficiency Testing Studies (PTS)

The 2010 collaborative PTS studies programme.

List of PTS planned for 2010

OMCL Annual Seminar

OMCL Annual Seminar, 25-29 May 2009
14th Annual Meeting of European Network of Official Medicines Control Laboratories (OMCL), Vienna, Austria, 25-29 May 2009

Additional Information and Downloads

The EU/EAA Network for Official Control Authority Batch Release of Biologicals for Human Use, The Regulatory Affairs Journal, June 2002

 

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