Agenda
8:00 AM — 8:30 AM
8:30 AM — 10:00 AM
Session 1: EUROPEAN UNION – ROLE AND RESPONSIBILITIES OF EUROPEAN10:00 AM — 10:30 AM
10:30 AM — 12:30 PM
Session 2: LIFECYCLE OF A MEDICINAL PRODUCT12:30 PM — 1:30 PM
1:30 PM — 3:00 PM
Session 3: EU LICENSING PROCEDURES – PART I3:00 PM — 3:30 PM
3:30 PM — 5:00 PM
Session 4: EU LICENSING PROCEDURES – PART II A5:00 PM — 6:00 PM
8:30 AM — 10:30 AM
Session 4 continued: EU LICENSING PROCEDURES – PART II B10:30 AM — 11:00 AM
11:00 AM — 12:30 PM
Session 5: PHARMACOVIGILANCE12:30 PM — 1:30 PM
1:30 PM — 2:30 PM
Session 6: VARIATIONS / POST APPROVAL CHANGES2:30 PM — 2:45 PM
2:45 PM — 3:15 PM
Session 7: HARMONISATION & DEFINED MEDICINAL PRODUCTS3:15 PM — 4:00 PM
Session 8: COMBINATION PRODUCTS4:00 PM — 4:30 PM
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