46th DIA Annual Meeting - Drug Information Association

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Wednesday, June 16 EDC in Phase 1 Trials: A CRO Perspective Brock Heinz Systems Integration Engineer, Spaulding Clinical Susan Bornstein, MPH Executive Vice President, eClinical Solutions, a Division of Eliassen Group Anthony W. Tolcher, MD Director, Clinical Research, South Texas Accelerated Research Therapeutics (START) • Basic-level content; • Primarily intermediate-level content; Primarily advanced-level content A CRO Perspective on Study Feasibility Lars-Olof Eriksson, PhD PAREXEL Consulting A Sponsor’s Perspective on Study Feasibility Otis Johnson, MPA Manager, Global Trial Optimization (GTO), Clinical Research Operations, Merck & Co., Inc. Site’s Perspective for Feasibility Assessments Geralyn Pumper, RN Mayo Clinic SESSION 305 CMC/GMP - CHEMISTRY, MANUFACTURING, AND CONTROLS/ GOOD MANUFACTURING PRACTICES 8:30 AM-10:00 AM LEVEL: • Room 145A Pharmacy credits offered Challenges in the Implementation of Quality-by-design Across the Pharmaceutical Industry SESSION CHAIRPERSON(S) Moheb M. Nasr, PhD, MS Director, Office of New Drug Quality Assessment, CDER, FDA This session will discuss progress and challenges of implementing qualityby-design (QbD) initiative among different industry sectors and regulatory authorities. State of QbD Implementation: Adoption, Successes, and Challenges Ted Fuhr, MBA Consultant, McKinsey & Company QbD Moving Forward: Opportunities and Challenges Helen N. Winkle Director, Office of Pharmaceutical Science, CDER, FDA Implementing QbD in FDA’s GMP Program Vibhakar Shah, PhD Senior Policy Advisor, Office of Compliance, Division of Manufacturing and Product Quality, CDER, FDA SESSION 306 CR/CS 1 - CLINICAL RESEARCH AND DEVELOPMENT/CLINICAL SUPPLIES 8:30 AM-10:00 AM LEVEL: • Room 149AB No More Questionnaires! Rethinking the Study Feasibility Assessment Process to Ensure Successful Implementation SESSION CHAIRPERSON(S) Beth D. Harper, MBA Chief Clinical Officer, Centerphase Solutions The traditional approach to feasibility assessment, using questionnaires, results in the typical site enrollment performance whereby
• Basic-level content; • Primarily intermediate-level content; Primarily advanced-level content Wednesday, June 16 Impact of On-demand Packaging and Labeling for Adaptive Trials Gerald Finken, MS, RPh CEO, Clinical Supplies Management The Key Role of Simulation in Planning and Implementing Clinical Supplies for Adaptive Trials Nitin R. Patel, PhD, MBA Chairman, Chief Technology Officer, and Co-founder, Cytel, Inc. Drug Supply Management for Adaptive Trials Nancy Burnham, MA Associate Director, GlaxoSmithKline SESSION 309 8:30 AM-10:00 AM LEVEL: • Room 151B CME credits offered CR/CS 4 - CLINICAL RESEARCH AND DEVELOPMENT/CLINICAL SUPPLIES How Many Clinical Trial Managers Does It Take to Manage a Trial? SESSION CHAIRPERSON(S) Jeanne M. Green, BSN, MSc Director, Clinical Operations, ExecuPharm, Inc. Projecting resource demand is an art and a science. Companies that manage resource allocation against demand with accuracy will preserve budgets, increase productivity, and create efficiency. Both large and small pharmaceutical and biotechnology companies are finding it increasingly difficult to stretch dollars and resources. This session will focus on CTM resourcing models currently in use, factors that go into development of algorithms, challenges with implementation, and future trends. Resourcing CTMs: A Mid-size Pharmaceutical Perspective Carrie L. Melvin, BSN Director, Clinical Operations, Millenium: The Takeda Oncology Company Resourcing CTMs: A Large-size Pharmaceutical Perspective Heather A. Meyers, MS Associate Director, Pfizer Inc Resourcing CTMs: A Small-size Pharmaceutical Perspective Lisa Robarge, MBA Director, Clinical Development, Achillion Pharmaceuticals, Inc. SESSION 310 CSP 1 - CLINICAL SAFETY AND PHARMACOVIGILANCE 8:30 AM-10:00 AM LEVEL: • Room 145B CME credits offered Pharmaceutical Packages and New Safety Legislation in the EU SESSION CHAIRPERSON(S) William W. Gregory, PhD Senior Director, Safety and Risk Management, Pfizer Inc Significant changes in pharmacovigilance requirements are expected in the European Union aimed at improving patient protection through better safety monitoring. This session will go through the essential pieces of the so-called pharmaceutical package, a set of new legislation and guidance aimed at reforming the regulation of the drug industry in the EU. Industry View on Proposed Changes to EU Pharmaco vigilance Legislation Barry Arnold, MD EU Qualified Person for Pharmacovigilance, AstraZeneca, UK A New Era for Pharmacovigilance in EU: Regulatory Perspective June Raine, MSc, MD Director, Division of Vigilance Risk Management of Medicines and Chair of the Pharmacovigilance Working Party, MHRA, UK SESSION 311 CSP 2 - CLINICAL SAFETY AND PHARMACOVIGILANCE 8:30 AM-10:00 AM LEVEL: • Room 143C CME, nursing, and pharmacy credits offered Can a Risk Management Program Save a Product from Withdrawal? SESSION CHAIRPERSON(S) Gerald A. Faich, MD, MPH Senior Vice President, SERRM, United BioSource Corporation Product safety can be improved by implementing a risk management program. Risk management programs can mitigate the risks of a product and make sure that only those people who will benefit most are able to use them. Risk management programs have helped bring products back to the market after they have been withdrawn for safety concerns. This session will explore how risk management programs can save products from withdrawal. The Tysabri Experience Representative Invited Vice President, Global Head, Drug Safety and Risk Management, Biogen Idec Inhaled Insulin Anders H. Boss, MD, FFPM Chief Medical Officer, MannKind Corporation FDA Point of View Gerald J. Dal Pan, MD, MPH Director, Office of Surveillance and Epidemiology, CDER, FDA SESSION 312 EC - ECLINICAL 8:30 AM-10:00 AM LEVEL: • Room 204BC CME and nursing credits offered Electronic Source Documents: Removing the Paper Burden from Sites and Sponsors SESSION CHAIRPERSON(S) Edward Stephen Seguine, Jr., MBA President, Clinical Ink This session will present the unique views/experiences of a site, data monitor, and CRO as they have implemented technology and adopted new business practices to capture source documents electronically. The presenters will focus on how the patient and study coordinators are affected both during the visit as well as in managing the patient data at the site, how source data verification and site monitoring visits are impacted, and how data management, reporting, and performance are improved. 83
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46th DIA Annual Meeting The agenda
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1 TABLE OF CONTENTS KEYNOTE SPEAKER
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3 KEYNOTE SPEAKER MARGARET A. HAMBU
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5 MEGATRACKS The 46th DIA Annual Me
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7 FEATURED REGULATORY AGENCY SESSIO
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9 DESTINATION DC Getting to the Wal
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11 46 TH DIA ANNUAL MEETING Sandra
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Continuing Education Overview of Pr
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Tutorials, Sunday, June 13 TUTORIAL
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Tutorials, Sunday, June 13 Learning
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Tutorials, Sunday, June 13 clarify
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Tutorials, Sunday, June 13 TUTORIAL
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• Basic-level content; • Primar
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Page 49 and 50: TUESDAY, JUNE 15 7:00 am-5:30 pm SP
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PharmaNet Development Group PharmaN
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Quorum Review IRB When Performance
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Thomson Reuters INFORMATION FOR FAS
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94 HOTEL INFORMATION PLEASE NOTE: T
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96 TUTORIAL SCHEDULE AND PRICING GU
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ADD Tutorials and/or Networking Rec
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46th DIA Annual Meeting Live Learni
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46th DIA Annual Meeting - Drug Information Association

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