S2C3:Clinical Trials of Drug Products

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S2C3:Clinical Trials of Drug Products

JanFourman,PhD, EdD,MBA, MSRA

S2C3:Clinical Trials of Drug Products

Eli Lilly – Pharma registration for diabetes/endocrine, women/men’s health, neural science, oncology, bone/muscle/joint therapeutic areas – 5 years
Eli Lilly – Pharmacovigilance – 7 years
Eli Lilly – Regulatory Intelligence – 3 Years
Purdue University and Roche Diagnostics – Teaching global pharma development, Africa and US
Consultant for Indiana Technical Assistance Program
Invited conference speaker
Published author

S2C3:Clinical Trials of Drug Products
S2C3:Clinical Trials of Drug Products

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Clinical Trials of Drug Products

Initial Processing of the IND

Clinical Hold

If it’s a go – are you up-to-date with the clinical trial trends?

Phase 1

Exploratory Studies

Phase 2

End-of-Phase 2 (EOP2) Meetings

Phase 3

ClinicalTrials.gov

Phase 4

Pharmacovigilance

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