PDA/FDA Joint Regulatory Conference

Parenteral Drug Association Connecting People, Science and Regulation ^®

2016 PDA/FDA Joint Regulatory Conference

Final Program

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Kelly Allan

P4 - Quality Assurance in the Year 2016 and Beyond | Quality Assurance Then and Now: The Journey Continues

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David Anderson

C5 - Combination Products | Postmarket Challenges for Meeting the Regulations for a Legacy Combination Product

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Thomas Arista

NEW | A2 - Audits | C4 - Risk Based Auditing

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Roger Asselta

NEW | Interest Group 6 - Packaging Science

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John Ayres, MD

A4 - Clinically Relevant Specifications | Assessing Product Quality Attributes Using Clinical Efficacy and Risk Assessment Inputs to Define Product Specifications

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Hal Baseman

B4 - Process Validation | Process Validation / Verification Evolution and Lessons Learned

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Ilisa Bernstein, PharmD, JD - C2

NEW | C2 - Supply Chain | U.S. FDA’s Efforts to Fight Falsified Medicines

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Ilisa Bernstein, PharmD, JD - P5

NEW | P5 - Compliance Update | CDER Office of Compliance Update

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CAPT Sean Boyd

NEW | P5 - Compliance Update | CDRH Compliance Update

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Scott Bozzone, PhD

NEW | Interest Group 11 - Process Validation

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Raphael Brykman

NEW | Breakfast VIII - Updates from CDER / OPQ | Presentation is Currently Unavailable

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Melissa Burns

C5 - Combination Products | FDA’s Perspective on Premarket and Postmarket Challenges for Combination Products

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Lucy Cabral, Karen Ginsbury and Sue Schniepp

NEW | Interest Group 10 - Management of Outsourced Operations and Supply Chain

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Cylia Chen

Breakfast VI - Quality Metrics / Culture | Update on PDA’s Quality Culture Assessment Pilot

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Karen D'Orazio

A3 - Quality Systems | Investigations and Poor Quality Systems – an FDA Perspective

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Rollins (Terry) Fairbanks, MD

NEW | Breakfast I - Human Factors

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David Fajgenbaum, MD

Presentation is Not Authorized for Distribution

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Carl Fischer

NEW | Interest Group 4 - Quality Risk Management

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Michael Folkendt

NEW | C1 - Quality Submissions | Improved Communications to Enhance Application Quality

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Kara Follmann

C1 - Quality Submissions | Tips on Developing an Application for FDA – Dos, Don’ts, and Complications

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Laurie Graham, PhD - A4

REVISED | A4 - Clinically Relevant Specifications | A Regulatory Perspective on Clinically Relevant Specifications

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Laurie Graham, PhD - B5

NEW | B5 - Regulatory Consideration | FDA Expedited Programs

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Donna Gulbinski

REVISED | P4 - Quality Assurance in the Year 2016 and Beyond | Today's Challenges‎ to Quality, and Future Opportunities

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Paul Hargreaves

A1 - International Efforts | PIC/S – What it Means for You

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Robert Higgins

REVISED | Breakfast III - Cybersecurity

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Shannon Hoste

NEW | Interest Group 9 - Combination Products

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Robert Iser - C3

NEW | C3 - ICH | ICH Q12 – Technical & Regulatory Opportunities

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Robert Iser-BRVIII

NEW | Breakfast VIII - Update from CDER / OPQ | Introduction to the Office of Process and Facilities

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Robert Iser-IG3

NEW | Interest Group 3 | One Quality Voice

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Brian Johnson

NEW | C2 - Supply Chain | How Industry is Mobilizing to Fight Falsified Medicines

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Zena Kaufman

A2 - Audits | The Skill of Auditing

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Michael Kopcha, PhD, RPh_B1

B1 - Continuous Manufacturing | A Regulatory Perspective on Continuous Manufacturing in the Pharmaceutical Sector

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Michael Kopcha, PhD, RPh - P3

P3 - Achieving Compliance by Focusing on Quality | Compliance to Quality: A Regulator’s Perspective

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Stephan Krause, PhD

NEW | Interest Group 7 - Biotechnology

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Emanuela Lacana, PhD

NEW | B3 - Biosimilars | Broad Overview of FDA Expectations for Biosimilars

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Nalini Lebzelter

NEW | Interest Group 2 - Regulatory Affairs | One Quality Voice

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Laurie Lenkel, JD

Breakfast IV - Ombudsman

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Lloyd Mager

REVISED | C2 - Supply Chain | Serialization Requirements and What This Means to You

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Mary Malarkey

P5 - Compliance Update

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Peter Marks, MD

P1 - Opening Plenary Session - Patient Perspective | FDA Keynote

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Marilyn Martinez, PhD

REVISED | A4 - Clinically Relevant Specifications | IVIVC Concepts and the Challenge of its Implementation for Parenteral Formulations

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Daniel McChesney, PhD

P5 - Compliance Update

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Grace McNally

NEW | B4 – Process Validation | Process Validation and Pre-Approval Inspections

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Jose Menezes, PhD

NEW | Interest Group 7 - Biotechnology

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Sue Miles

B1 - Continuous Manufacturing | Continuous Manufacturing and Implications for the Manufacturer's Quality

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Theresa Mullin, PhD

A1 - International Efforts | ICH – Restructuring and the Future

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Moheb Nasr, PhD

REVISED | C3 - ICH | ICH Q12 : A Unique Opportunity to Realize 21st Century Quality Vision

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QuynhNhu Nguyen, MS

NEW | Interest Group 9 - Combination Products

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Mark Paradies

REVISED | A3 - Quality Systems | Identification of True Root Cause – and Impact to the Quality System

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