アジェンダ
8:00 AM — 8:30 AM
8:30 AM — 8:45 AM
Welcome and Introductions8:45 AM — 10:45 AM
Module 1: Overview Of Drug Development10:45 AM — 11:00 AM
11:00 AM — 11:45 AM
Table Exercise 111:45 AM — 12:30 PM
Module 2: Candidate Identification/Preclinical Testing12:30 PM — 1:30 PM
1:30 PM — 2:30 PM
Module 3: Phase 12:30 PM — 3:30 PM
Module 4: Phase 23:30 PM — 3:45 PM
3:45 PM — 4:30 PM
Table Exercise 2a: Phase 2 Risk-Return Decisions4:30 PM — 5:00 PM
Module 4: Phase 2 (continued)8:00 AM — 8:30 AM
8:30 AM — 9:00 AM
Table Exercise 2b: Phase 3 Decision9:00 AM — 10:00 AM
Module 5: Phase 3 and Regulatory Review10:00 AM — 10:15 AM
10:15 AM — 10:45 AM
Table Exercise 3: Decision to File10:45 AM — 12:15 PM
Module 5: Phase 3 and Regulatory Review (continued)12:15 PM — 1:15 PM
1:15 PM — 2:45 PM
Module 6: Phase 4 and Life Cycle Management2:45 PM — 3:15 PM
Table Exercise 4: Life Cycle Management Choices3:15 PM — 3:30 PM
Questions & Answers and Wrap-up