Regulatory Structure and Content of the Regulations - Regulatory Requirements for Pharmaceutical Companies

08.00 - 08.30

Welcome, Introduction, Presentation of the Speaker
08.30 - 09.30 Regulations in Europe
  • Regulations
  • Directives
  • Guidelines
  • Notices
09.30 - 10.30 Regulations in the USA
  • CFR
  • Guidances
  • FOI
10.30 - 10.45 Break

 

10.45 - 11.45 Harmonised Regulations
  • WHO
  • PIC
  • ICH
  • IMDRF/GHTF
  • ISO
11.45 - 13.00 Common - Differences
  • Europe - USA - ISO
13.00 - 13.30 Discussion

 

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