Product Quality Research Institute – Just another ...



October 58:30 – 10:15 AMPlenary SessionModerators: Margaret Szymczak, J&J and Lawrence Yu, FDASpeakers:Janet Woodcock, FDAMichael Thien, MerckBernhardt Trout, Massachusetts Institute of TechnologyEMERGING REGULATORY INITIATIVESOctober 510:30 AM – 12:15 PMBiopharmaceutics – BCS Biowaivers Moderators: Vinod Shah, PQRI and Mehul Mehta, FDASpeakers:BCS Guidance and Biowaivers- BCS Monographs - Vinod Shah, PQRIBertil Abrahamsson, AstraZenecaYu Chung Tsang, ApotexImplementation of BCS Guidance, Analysis of BCS Submissions to FDA and Guidance Update - Mehul Mehta, FDAOctober 5 1:15 – 5:00 PMPharmaceutical Product Lifecycle Management – Q12 Moderators: Moheb Nasr, GlaxoSmithKline and Robert Iser, FDASpeakers:Introduction to Product Lifecycle Management - Robert Iser, FDAMark Rosolowsky, Bristol-Myers SquibbICH-Q12: Opportunities for the Generic Drug Industry - Keith Webber, Perrigo Lifecycle Management: Future Vision / ICH Q12 - Moheb Nasr, GlaxoSmithKlineChange Management - Liam Feely, AbbVieIngrid Markovic, FDAMahesh Ramanadham, FDAOctober 68:30 – 10:15 AMDissolution Testing and Specification for BCS I and III Drugs in Immediate Release Products Moderators: Richard Lostritto, FDA and Gregory Amidon, University of MichiganSpeakers:The Future of In Vivo Predictive Dissolution Methods - Gregory Amidon, University of MichiganRik Lostritto, FDALucinda Buhse, FDAOctober 6 10:30 AM – 12:15 PMDissolution Testing and Specification for Extended Release Products Moderators: Paul Seo, FDA and Jim Polli, University of Maryland Speakers:Designing Quality into ER Products: Technology Selection - Alfred Berchielli, PfizerUse of Pharmacoscintgraphy in ER Formulation Understanding - David Sperry, Eli Lilly & CompanyMitigating Patient Risks Using Dissolution Testing in Manufacturing ER Products - Yihong Qiu, AbbVieOctober 6 1:15 – 3:00 PMQuality Metrics Moderators: Tara Gooen Bizjak, FDA and Louis Yu, Perrigo Speakers:Tara Gooen Bizjak, FDAPaul Weninger, PerrigoMairead Goetz, NovartisDiane Hagerty, GenentechOctober 6 3:15 – 5:00 PMBotanical Drug Development and Quality Standards Moderators: Sau Larry Lee, FDA and Steven Hoag, University of MarylandSpeakers:Sau Larry Lee, FDAAspects of the Discovery and Development of Plant-Derived Drugs - Douglas Kinghorn, The Ohio State UniversityHaibin Qu, Zhejiang UniversityVikas Moolchandani, Amway Inc.October 6 5:00 – 6:30 PMHow to Interact and Communicate with FDA on Quality IssuesModerator:? Giuseppe Randazzo, FDASpeakers:? Robert Gaines, FDAHow to Interact and Communicate with FDA on Quality Issues - Tanya Clayton, FDARegulatory Submission, Assessment and InspectionOctober 510:30 AM – 12:15 PMBreakthrough Therapy – CMC ChallengesModerators: Ganapathy Mohan, Merck and Margaret Caulk, FDASpeakers:Breakthrough Therapy – CMC Challenges - Ganapathy Mohan, MerckJohn Groskoph, Pfizer Inc.Review Considerations for Break-Through-Designated Products - Olen Stephens, FDAOctober 5 1:15 – 5:00 PMPre-Approval and Surveillance InspectionModerators: Mary Oates, Pfizer and Rebeca Rodriguez, FDASpeakers:Ambarish Singh, BMSAn Industry View of Surveillance Inspections - Mary Oates, PfizerNancy Rolli, FDAChristine Moore, FDAOctober 68:30 – 10:15 AMRisk-based Regulatory AssessmentModerators: G.K. Raju, Light Pharma and Ramesh Sood, FDASpeakers:Roger Nosal, PfizerOctober 6 10:30 AM – 12:15 PMHow Quality Risk Management can Enable a More Effective Pharmaceutical Quality System Resulting in Improved Product QualityModerators: Dave Doleski, FDA and Martin VanTrieste, AmgenSpeakers:Fionnuala Walsh, Eli Lilly Mark Swatling, AstraZenecaTom Cosgrove, FDAOctober 6 1:15 – 5:00 PMFDA Integrated Quality Assessment: Common Deficiencies/Information RequestModerators: Ashley Boam, FDA and Tony Tong, Teva Speakers: Mike Saleh, Pfizer Siva Vaithiyalingam, Teva Sarah Pope Miksinski, FDASusan Rosencrance, FDAChallenges Integrating Regulatory Filings and Pre-Approval Inspection with the Expectations of Current Regulatory Guidance - Tony Mire-Sluis, AmgenProduct and Process DevelopmentOctober 510:30 AM – 12:15 PMCurrent Challenges in the Characterization of Complex Drug Formulations Containing NanomaterialsModerators: Katherine Tyner, FDA and Henry Havel, Nanomedicines AllianceSpeakers:Quality Considerations and Regulatory Perspectives for Drug Products Containing Nanomaterials - Katherine Tyner, FDAIndustrial Perspective on Nanomedicine Characterization Strategies - Don Parsons, BIND Therapeutics, Inc.Nanoparticle Size Analysis: A Survey and Review -Marc Wolfgang, CeruleanOctober 5 1:15 – 5:00 PMBiosimilar Product Assessment – How Similar is Similar?Moderators: Anna Schwendeman, University of Michigan and Emanuela Lacana, FDASpeakers:Implementing the Biologics Price Competition and Innovation Act of 2009 and Quality Considerations for the Development of Biosimilar Products - Marjorie Shapiro, FDAAnna Schwendeman, University of Michigan Corinna Sonderegger, SandozChallenges with Establishing a Control Strategy for Biosimilars - Barbara Rellahan, AmgenThe Making of Advanced Biosimilars: Enabling Advanced Biosimilars through Technical Development and Manufacturing - Orlando Jaquez, BiogenOctober 68:30 – 10:15 AMPalatability and Swallowability-Benefits of Transdisciplinary LearningModerators:Arzu Selen, FDA and Rob Ju, AbbVie Speakers: The Role of Tribology in Oral Processing -Stefan Baier, PepsiCoIn-Vitro Taste Sensors:? Methods, Uses and Opportunities - Julie Lorenz, ZoetisOctober 6 10:30 AM – 12:15 PMAlternatives for Content Uniformity Acceptance Criteria and Stratified SamplingModerators:Geoffrey Wu, FDA and Lisa Tan, GPhASpeakers:Jon Clark, USPJames Drennen, Duquesne UniversityAlex Viehmman, FDAOctober 6 1:15 – 5:00 PMThe Science of Tech Transfer/Scale-upModerators: Grace McNally, FDA and Ilgaz Akseli, Boehringer-Ingelheim Speakers: Implementing Fundamental Pharmaceutical Science and Materials/Engineer Expertise in Scale-Up - Ecevit Bilgili, New Jersey Institute of Technology Stephen Conway, Merck Alberto Cuitino, Rutgers University Mitigating Product Risk in Manufacturing or During Formulation Development and Identify Opportunities to Maximize Efficiency -Ilgaz Akseli, Boehringer Ingelheim San Kiang, Independent Consultant Manufacturing, Risk Management and Quality AssuranceOctober 510:30 AM – 12:15 PMHow to Prevent, Detect, and Respond to Data Integrity EventsModerators: Paula Katz, FDA and Joseph Famulare, Genentech Speakers: Paula Katz, FDA Building Business Processes that Optimize Accurate and Reliable Data - Monica Cahilly, Green Mountain Quality Assurance Benefits of Combining Quality Risk Management (Q9) with Pharmaceutical Quality System - Joseph Famulare, Genentech October 5 1:15 – 5:00 PMContinuous ManufacturingModerators: Thomas O’Connor, FDA and Diane Zezza, Novartis Speakers:Scientific Considerations for the Assessment of Continuous Manufacturing Processes - Thomas O’Connor, FDAYanxi Tan Cain, NovartiscGMP and Regulatory Considerations for Continuous Manufacturing Processes - Patric Klotzbuecher, FDAHayden Thomas, VertexQuality and Regulatory Considerations for Continuous API: A Case Study - Douglas Mans, GlaxoSmithKlineOctober 68:30 AM – 12:15 PMHow to Monitor, Control, and Improve Product Quality using Process CapabilityModerators: Barbara Allen, Eli Lilly & Company and Larisa Wu, FDASpeakers: Pharmaceutical Product Quality, Quality by Design, cGMP, and Quality Metrics - Lawrence Yu, FDADaniel Peng, FDAQuality as Foundation for OPEX - Thomas Friendli, University of St. GallenThe Journey From Good to Great: Process Monitoring Leads to Improving Product Quality- Martin VanTrieste, AmgenBryan Winship, MylanProcess Capability and Relationship to Quality Management - Barbara Allen, Eli Lilly & CompanyOctober 6 1:15 – 5:00 PMHow to Identify Critical Quality Attributes and Critical Process ParametersModerators: Scott Furness, FDA and Bruce Johnson, Perrigo Speakers: Generic Pharma Perspective on the Identification of Critical Quality Attributes and Critical Process Parameters- Bruce Johnson, PerrigoFDA Perspective on Identification of CQAs, CMAs and CPPs in A/NDAs - Jennifer Maguire, FDA Daniel Peng, FDA Generic Pharma Perspective on the Identification of Critical Quality Attributes and Critical Process Parameters - Bruce Johnson, Perrigo A Structured Statistical Approach to Aid the Assessment of Process Parameter Criticality- Ke Wang, Pfizer Identification of CPPs based on CQAs and Mechanistic Process & Product Understanding: A Case Study - Ajit Narang, BMS81975047.1 ................
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