Agenda
8:00 AM — 8:30 AM
8:30 AM — 8:45 AM
INTRODUCTION8:45 AM — 9:15 AM
SESSION 1: DRUG DEVELOPMENT9:15 AM — 10:00 AM
SESSION 2: QUALITY FRAMEWORK10:00 AM — 10:30 AM
10:30 AM — 11:15 AM
SESSION 3: REGULATORY OVERVIEW11:15 AM — 12:00 PM
SESSION 4: CLINICAL DEVELOPMENT12:00 PM — 1:00 PM
1:00 PM — 1:30 PM
SESSION 5: STUDY DESIGN1:30 PM — 3:00 PM
SESSION 6: STUDY PLANNING3:00 PM — 3:30 PM
3:30 PM — 4:30 PM
SESSION 6 (CONTINUED): STUDY PLANNING4:30 PM — 5:30 PM
SESSION 7: STUDY PREPARATION5:30 PM — 6:30 PM
6:30 PM — 6:30 PM
8:30 AM — 10:15 AM
SESSION 8: RESOURCING10:15 AM — 10:45 AM
10:45 AM — 11:45 AM
SESSION 8 (CONTINUED): RESOURCING11:45 AM — 12:15 PM
SESSION 9: IMP MANAGEMENT12:15 PM — 1:15 PM
1:15 PM — 3:00 PM
SESSION 10: STUDY COMMUNICATION3:00 PM — 3:30 PM
3:30 PM — 4:45 PM
SESSION 10 (CONTINUED): STUDY COMMUNICATION4:45 PM — 4:45 PM
8:30 AM — 10:00 AM
SESSION 11: SITE MANAGEMENT10:00 AM — 10:30 AM
10:30 AM — 12:30 PM
SESSION 12: RISK MANAGEMENT12:30 PM — 1:30 PM
1:30 PM — 2:15 PM
SESSION 13: EVALUATION AND REPORTING2:15 PM — 2:45 PM
SESSION 14: DRUG SAFETY2:45 PM — 2:45 PM
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