2017 PAC iAM Workshop

Parenteral Drug Association Connecting People, Science and Regulation ^®

Program Agenda

2017 PDA PAC iAM Workshop - Agenda

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Mentimeter Results

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Anders Vinther, PhD

P1: Opening Plenary: Why is a Global Dialog Important? Why Now?

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Robert Iser, MS

P1: Opening Plenary: Why is a Global Dialog Important? Why Now?

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Isabelle Colmagne-Poulard, PharmD

P1: Opening Plenary: Why is a Global Dialog Important? Why Now?

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Frank Montgomery, PhD

P2: Established Conditions and Change Categorization

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Lisa Skeens, PhD

P2: Established Conditions and Change Categorization

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Emma Ramnarine, MS

P3: Elements of Lifecycle Management Strategy

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Mahesh Ramanadham, PharmD

P3: Elements of Lifecycle Management Strategy

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Group 1: Analytical Method Change (Biologic) Poster

Alleviating Regulatory Burden of Post-Approval Method Change

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Group 2: Material Change (Oral Drug Product) Poster

Raising Requirements in One Country to Achieve Harmonization Across Many?

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Group 3: Manufacturing Process Change to Isolator (Injectable) Poster

Will the PACMP Reduce Regulatory Filing Requirements and Alleviate Supply Chain Concerns?

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Attendee Presentations