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Parenteral Drug Association
Connecting People, Science and Regulation
®
Parenteral Drug Association
Connecting People, Science and Regulation
®
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Attendee Presentations
2017 PAC iAM Workshop
Program Agenda
2017 PDA PAC iAM Workshop - Agenda
(?)
Mentimeter Results
(?)
Anders Vinther, PhD
P1: Opening Plenary: Why is a Global Dialog Important? Why Now?
(?)
Robert Iser, MS
P1: Opening Plenary: Why is a Global Dialog Important? Why Now?
(?)
Isabelle Colmagne-Poulard, PharmD
P1: Opening Plenary: Why is a Global Dialog Important? Why Now?
(?)
Frank Montgomery, PhD
P2: Established Conditions and Change Categorization
(?)
Lisa Skeens, PhD
P2: Established Conditions and Change Categorization
(?)
Emma Ramnarine, MS
P3: Elements of Lifecycle Management Strategy
(?)
Mahesh Ramanadham, PharmD
P3: Elements of Lifecycle Management Strategy
(?)
Group 1: Analytical Method Change (Biologic) Poster
Alleviating Regulatory Burden of Post-Approval Method Change
(?)
Group 2: Material Change (Oral Drug Product) Poster
Raising Requirements in One Country to Achieve Harmonization Across Many?
(?)
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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