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PharmaLex International to Participate in EU Marketing Authorisation – Update on Generics, Variations and eCTD Forum

PharmaLex International is to participate at the EU Marketing Authorisation – Update on Generics, Variations and eCTD Forum, which will take place in Sofia, Bulgaria, on 11 and 12 May this year. The schedule is as follows.

Day one: 11 May 2010

  • Generics: full application, bibliographic application, hybrid application
  • Update variations regulation – the classification system
  • National variations in Bulgaria

Day two: 12 May 2010

  • eCTD compilation for European submissions
  • eCTD submissions – the Bulgarian regulatory requirements

Speakers at this event will include:

  • Dr Maren von Fritschen, PharmaLex, Germany
  • Lyudmil Antonov, Bulgarian Drug Agency (BDA), Sofia, Bulgaria
  • Dr Peter Bachmann, BfArM, Germany
  • Associate Professor Tatyana Benisheva-Dimitrova, Faculty of Public Health, Medical University – Sofia, Bulgaria
  • Dr Elena Masseva Bulgarian Drug Agency (BDA), Sofia, Bulgaria
  • Holger Spalt, Extedo, Ottobrunn, Germany

Contact PhamaLex International for further information.