S1C2 :Prescription Drug Product Submissions

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S1C2 :Prescription Drug Product Submissions

JanFourman,PhD, EdD,MBA, MSRA

S1C2 :Prescription Drug Product Submissions

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

S1C2 :Prescription Drug Product Submissions
S1C2 :Prescription Drug Product Submissions


Prescription Drug Product Submissions

What is an Investigational New Drug (IND) application?

How to Organize the IND:

Electronic Common Technical Document (eCTD) – Focus on Module 2

Target Product Profile (TPP)

Submission Strategies:

New Chemical Entities (NCEs)

Fast Track Designation

Breakthrough Therapy Designation

Accelerated Approval

Priority Review Voucher

Orphan Drug Designation