Regulatory Structure Regulatory Requirements for Pharmaceutical Companies

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The agenda proposal aside has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

Agenda Proposal

08.00 - 08.30

Welcome, Introduction, Presentation of the Speaker

08.30 - 09.30 Regulations in Europe
  • Directives
  • Guidelines
  • Notices
09.30 - 10.40 Regulations in the USA
  • CFR
  • Guidances
  • FOI
10.30 - 10.45 Break
10.45 - 11.45 Harmonised Regulations
  • WHO
  • PIC
  • ICH
  • GHTF
  • ISO
11.45 - 13.00 Common - Differences
  • Europe - USA - ISO
13.00 - 13.30 Discussion

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