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SESSION 5: NON-EU GVP GUIDELINES, GVP RELEVANT GUIDANCES, DATA SOURCES ETC.
Session Chair(s)
Michael Busch-Sørensen
Board Member
Danish Society for Pharmacoepidemiology, Denmark
Michael Forstner, PhD, MPH, MSc
Head of Global Safety Science
SOBI, Switzerland
- Revision GCP data privacy prospective vs secondary data
- Implementation of GVP outside EU
- ISPE guidances (GPP, Ethics, Privacy, contracts etc.)
- ENCePP & EU PAS Registry
- CONSORT & study check list
Speaker(s)
NON-EU GVP GUIDELINES, GVP RELEVANT GUIDANCES, DATA SOURCES ETC.
Michael Busch-Sørensen
Danish Society for Pharmacoepidemiology, Denmark
Board Member
NON-EU GVP GUIDELINES, GVP RELEVANT GUIDANCES, DATA SOURCES ETC.
Michael Forstner, PhD, MPH, MSc
SOBI, Switzerland
Head of Global Safety Science
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