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.
Twitter