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Oracle acquires Relsys, Californian editor of software of the risks management for the attention of the pharmaceutical industry and biotechnologies. 

 

  • The integration of the Relsys solutions has to allow the American publisher, the competitor of the German group SAP, to supply a continuation of pharmacovigilance applications (risk supervision, from the clinical trials to the use of medicines in real situation) within the framework of the Health Sciences Global Business unit.

  • With the Relsys integration, Oracle is ideally positioned to help their customers to improve the safety of medicines by supplying a solution which groups together risk management tools and advanced analysis.



   EMEA NEWS

 

  • February 10, 2010:

- European Medicines Agency publishes tenth weekly pandemic pharmacovigilance report, Press Office

  • February 08, 2010:

- Revision of Appendix II "Translation of the MedDRA" terminology for frequencies and system organ classes to be used in SPC Section 4.8 "Undesirable effects": minor changes in the Greek version, Human Medicines, Application Procedures- QRD- Product Information Templates.

  • February 03, 2010:

- European Medicines Agency publishes ninth weekly pandemic pharmacovigilance report, Press Office



 

Bulletin of the French health authority dated from January 08, 2010:

·      Bulletin des vigilances n° 48 (08/01/2010)


  

Health Authority News:

 

  1. PUT THE QUALITY IN THE HEART OF the PRACTICES AND THE INDIVIDUAL BEHAVIOR
  2. PUT THE QUALITY IN THE HEART OF the COLLECTIVE CHOICES
  3. STRENGTHEN THE PERFORMANCE, THE TRANSPARENCY AND THE EXPERTISE OF THE INSTITUTION
 
 News of 2009

 

 

 

 



 

  • February 16, 2010:

- FDA Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp

  • January 29, 2010:

- FDA issued a Drug Safety Communication: Serious liver disorder associated with the use of Videx/Videx EC (didanosine) 

  • January 26, 2010:

- Guidance for Industry: Assessment of Abuse Potential of Drugs

- MedWatch Alert - Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment