Agenda
7:30 AM — 8:00 AM
8:00 AM — 8:15 AM
WELCOME AND INTRODUCTION8:15 AM — 8:45 AM
SESSION 1: INTRODUCTION TO REGULATION OF DRUGS AND BIOLOGICS8:45 AM — 9:15 AM
SESSION 2: THE DRUG DEVELOPMENT PROCESS: AN OVERVIEW9:15 AM — 10:00 AM
SESSION 3: THE IND - A GENERAL INTRODUCTION10:00 AM — 10:15 AM
10:15 AM — 11:15 AM
SESSION 4: THE IND IN DETAIL - ITEMS 1-611:15 AM — 12:30 PM
SESSION 5: SPECIAL TOPICS FOR CLINICAL RESEARCH UNDER AN IND12:30 PM — 1:30 PM
1:30 PM — 2:15 PM
SESSION 6: IND IN DETAIL - ITEM 72:15 PM — 3:00 PM
SESSION 7: IND IN DETAIL - ITEMS 8, 9 AND 103:00 PM — 3:15 PM
3:15 PM — 4:00 PM
SESSION 8: IND IN DETAIL - ADDITIONAL TOPICS4:00 PM — 5:00 PM
SESSION 9: QUALITY ASSURANCE IN DRUG DEVELOPMENT (GXPS)5:00 PM — 6:00 PM
8:00 AM — 8:30 AM
SESSION 10: FDA’S ACTIONS ON THE ORIGINAL IND & FUTURE AMENDMENTS8:30 AM — 9:45 AM
SESSION 11: ACTIVITIES AND SUBMISSIONS AFTER THE ORIGINAL IND9:45 AM — 10:00 AM
10:00 AM — 11:00 AM
SESSION 12: REPORTING ADVERSE EVENTS (AES) DURING CLINICAL TRIALS11:00 AM — 12:00 PM
SESSION 13: THE NDA IN CTD FORMAT12:00 PM — 1:00 PM
1:00 PM — 2:30 PM
SESSION 14: THE NDA IN CTD FORMAT: WHAT IS A CTD?2:30 PM — 4:00 PM
SESSION 15: THE NDA IN CTD FORMAT4:00 PM — 4:15 PM
4:15 PM — 5:00 PM
SESSION 16: THE FDA AND RISK MANAGEMENT9:30 AM — 9:45 AM
9:45 AM — 11:15 AM
SESSION 18: POST-NDA APPROVAL REGULATORY REQUIREMENTS11:15 AM — 12:30 PM
SESSION 19: INTERACTIONS WITH FDA12:30 PM — 1:30 PM
1:30 PM — 3:00 PM
SESSION 20: MOCK FDA MEETING3:00 PM — 3:15 PM
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