Introduction

Monica Lee Whitmire, M.S., B.S., B.S., MT (ASCP)

AAPS Regulatory Sciences Section 2015 Chair Elect

PPD, Second Shift Supervisor, Research Scientist

1 11/4/2014

General Disclaimer

The presentations should not be considered, in whole or in

part as being statements of policy or recommendation by

PPD or any regulatory body (domestic or international).

Throughout the presentations representative products or

organizations may be used, no endorsement is either

intended or implied.

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CORE Team Co-Chairs

Ganapathy Mohan, Ph.D., Merck

Kim Huynh-Ba, M.S., P.M.P., Pharmalytik

Members Shelley Durazo, M.S., RxREVU, AJE

Monica Whitmire, M.S., B.S., B.S., MT (ASCP), PPD

Shanthi Sethuraman, Ph.D., Eli Lilly and Company

Umang Shah, Ph.D., Novartis

Jahnavi Kharidia, Ph.D., Infinity Pharmaceuticals

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Jane Chang, Ph.D., FDA

Paula Webb, M.S., JHWEBB Consulting LLC

Chinmay Shukla, Ph.D., FDA

Darlene Noci, M.L.A., R.A.C., Infinity Pharmaceuticals, Inc.

Anthony Destefano, Ph.D.,

YourEncore

Nanda Subbarao, Ph.D., Biologics Consulting Group, Inc.

Jay Rajagopalan, Ph.D.,

PPD

Marjorie Egan, Ph.D., Infinity Pharmaceuticals

Jianmei Kochling, Ph.D., Genzyme

Eda Ross Montgomery, Ph.D.,

Shire Pharmaceuticals

Tomasz Grabowski D.V.M., Ph.D., Polpharma Biologics

Yu Chung Tsang, Ph.D.,

Apotex Inc.

Holly Groelle, Ph.D., PPD

Ann Marie Assumma, M.S.,

Progenics Pharmaceuticals, Inc.

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Reviewers

1. Introduction to Regulatory Sciences: An Overview CAPT. Dennis Bashaw, Pharm.D., FDA

2. Regulatory Processes Leading to IND Jogarao Gobburu, M.B.A., Ph.D., University of Maryland

3. Regulatory Processes Leading to NDA Submission Ramani Raghavan, Ph.D., Genentech

4. Commercialization and Post Submission Support Frank Diana, Ph.D., Endo Pharmaceuticals

5. A Close Look at CMC Sections Lynn Gold, Ph.D., Camargo Pharmaceutical Services

Edward Narke, Ph.D., D.S. InPharmatics

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Lectures 1 - 5

6. Regulatory Responsibilities to Ensure Product Quality Sharmista Chatterjee, Ph.D., FDA

Kristi Griffiths, Ph.D., Eli Lilly and Company

7. Europe (EMA) and Canada (Health Canada) Umang Shah, Ph.D., Novartis

8. Global Regulatory Affairs Ganapathy Mohan, Ph.D., Merck

9. Regulatory Intelligence and Staying Informed Shanthi Sethuraman, Ph.D. and Marjo Gazak, Ph.D., Eli Lilly and Company

10. Regulatory Compliance/Requirements and Guidance Kim Huynh-Ba, M.S., P.M.P., Pharmalytik

Prabu Nambiar, Ph.D., M.B.A., R.A.C., Syner-G Pharma

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Lectures 6 - 10

Essential Regulatory Affairs for Pharmaceutical Scientists: a Live Session of Regulatory Affairs 101 eLearning Course

Introduction to Regulatory Sciences (Monica)

Regulatory Processes Leading to IND and NDA Submissions (Lynn)

Commercialization and Post Submission Support (Kim)

Regulatory Responsibilities to Ensure Product Quality: Quality Systems,

Quality by Design (QbD) (Shanthi)

A Close Look at Chemistry Manufacturing and Controls (CMC) Sections

(Lynn)

Global Regulatory Affairs Processes in the Emerging Markets, Europe

(EMA), and Canada (Health Canada) (Kim)

Regulatory Intelligence, Staying Informed and Regulatory Compliance

Requirements (Shanthi)

Q&A (Monica)

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Introduction to Regulatory Sciences

Fit for purpose, phase appropriate, and

scientifically sound…project progression

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IND NDA Market

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Hypothesis Generation to First in Human

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Phase II to Regulatory Review

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“Although the FDA does have resources in foreign countries, the FDA does not have the resources to “go it alone”, co-operation is the wave of the future.”

Lecture 1, CAPT E. Dennis Bashaw, Pharm.D., FDA

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Lecture 1,

CAPT E. Dennis Bashaw, Pharm.D., FDA

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Lecture 1,

CAPT E. Dennis Bashaw, Pharm.D., FDA

Collaboration and cooperation are required to make safe, effective, quality medicines…

Essential Regulatory Affairs for Pharmaceutical Scientists: a Live Session of Regulatory Affairs 101

eLearning Course

Introduction to Regulatory Sciences (Monica)

Regulatory Processes Leading to IND and NDA Submissions (Lynn)

o Commercialization and Post Submission Support (Kim)

o Regulatory Responsibilities to Ensure Product Quality: Quality Systems, Quality by

Design (QbD) (Shanthi)

o A Close Look at Chemistry Manufacturing and Controls (CMC) Sections (Lynn)

o Global Regulatory Affairs Processes in the Emerging Markets, Europe (EMA), and

Canada (Health Canada) (Kim)

o Regulatory Intelligence, Staying Informed and Regulatory Compliance Requirements

(Shanthi)

o Q&A (Monica)

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