46th DIA Annual Meeting - Drug Information Association

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Wednesday, June 16 SESSION 399D IT 2 - INFORMATION TECHNOLOGY 3:30 PM-5:00 PM LEVEL: • Room 207B Service-oriented and Event-driven Architectures: Modern Architectural Patterns in a Complex Enterprise SESSION CHAIRPERSON(S) Douglas M. Doedens, MS Senior Director, Integration and Standards, Oracle Corporation Health Sciences Global Business Unit This session will educate business users on the key advantages of implementing a service-oriented and event-oriented architecture within a pharmaceutical company’s enterprise. It’s Not the Application, but the Integrations Among Them, That Matters Jaydev Thakkar, MS, PMP Principal Architect, IS Enterprise Architecture, Amgen Inc. Applying Service- and Event-driven Architecture to Enable the Business of Clinical Development David Pasirstein, MS Director, Business Architecture, Global Clinical Trial Operations, MRL IT, Merck & Co., Inc. SESSION 399E MC - MEDICAL COMMUNICATIONS 3:30 PM-5:00 PM LEVEL: • Room 143C CME, nursing, and pharmacy credits offered The Patient Perspective SESSION CHAIRPERSON(S) Nancy D. Smith, PhD Former Director, Office of Training and Communications, CDER, FDA There is a wealth of information about the risks and benefits of medicines available to patients. However, much of it is written in a way that makes it almost incomprehensible to anyone without a background in health care. Also, some of the information is biased and/or misleading. This session will focus on the needs of patients and how we can all work together to better serve these needs. The session will present several success stories from industry and patient advocacy groups. These will be discussed from both a regulatory and an academic perspective. Emphasis will be on ways we can all work together to improve patient education and provide better information to everyone. Drug Information and the Patient Perspective Nancy D. Smith, PhD Former Director, Office of Training and Communications, CDER, FDA Involving Patients: An FDA Perspective Theresa A. Toigo, MBA, RPh Director, Special Health Issues, Office of the Commissioner, FDA Patient Advocacy Group Perspective Jeff Allen, PhD Executive Director, Friends of Cancer Research • Basic-level content; • Primarily intermediate-level content; Primarily advanced-level content SESSION 399F MW - MEDICAL/SCIENTIFIC WRITING 3:30 PM-5:00 PM LEVEL: • Room 152B Global Strategies in Medical Writing: A Perspective from Asia SESSION CHAIRPERSON(S) Leyna Mulholland, PharmD, PhD Director, Global Regulatory Affairs, Hoffmann-La Roche Inc., Japan Global clinical trials for the international release of a drug are costly and lengthy, yet the potential to streamline processes does exist. The development in Asia follows US or EU’s approach and Asia does not start its development until the proof of concepts is well established in the US or EU. With the increase in development in Asia, there is a great need for proactive study design and plans, which can maximize the use of global documents that could cover Asia. This session examines the development and implementation of a global development model and discusses different options to consider from a medical writing perspective in Asia. CTD: Does One Size Fit All? Jo Vibe Tolshave, MSc Medical Writer, Specialist, H. Lundbeck A/S, Denmark How to Be Successful in Global Medical Writing: Japan Perspective Yuko Kojima, RPh Senior Manager, Japan Medical Communications, Eli Lilly Japan K.K., Japan SESSION 399G 3:30 PM-5:00 PM LEVEL: • Room 103A CME credits offered NC - NONCLINICAL LABORATORY SAFETY ASSESSMENT Update and Experience with ICH M3R2 SESSION CHAIRPERSON(S) Abigail C. Jacobs, PhD Associate Director, Pharmacology/Toxicology, Office of New Drugs Immediate Office, CDER, FDA Major revisions were incorporated into ICH M3R2, which was finalized in June 2009. Changes were made to existing sections, and new sections were added. These included sections on acute toxicity studies, limit dose in toxicity studies, duration of repeat dose studies for non-rodents, estimation of the first dose in human, exploratory clinical studies:limited clinical studies with nonclinical testing program directed only to support those early exploratory approaches, and reproduction toxicity studies. New material was included on timing for special studies, such as disproportionate metabolite studies, toxicity studies to support clinical trials in pediatric populations, immunotoxicity studies, phototoxicity studies, nonclinical abuse liability studies, and fixed combination drug nonclinical studies. Introduction Abigail C. Jacobs, PhD Associate Director, Pharmacology/Toxicology, Office of New Drugs Immediate Office, CDER, FDA An Industry Perspective Joseph J. DeGeorge, PhD Vice President, Global Safety Assessment, Merck & Co., Inc. An EU Perspective David R. Jones, MS Expert Pharmacotoxicologist, MHRA, UK 108
• Basic-level content; • Primarily intermediate-level content; Primarily advanced-level content Wednesday, June 16 SESSION 399H OS - OUTSOURCING 3:30 PM-5:00 PM LEVEL: • Room 147B Resource Management in a Virtual Model: Effective and Efficient Spending SESSION CHAIRPERSON(S) Gregory E. Dombal Managing Partner, Halloran Consulting Group Inc. Virtual development models offer the promise of bringing the right expertise to bear on a project at the right time with minimal company infrastructure. When effective, this model can offer an extremely costeffective approach to ensure efficient progress through the development cycle. However, if poorly executed, virtual development can be derailed by exorbitant outsource and consultant costs. A thorough and detailed understanding of how to plan for and integrate the use of a variety of external sources is essential for the program leader in a virtual development setting. This session will explore methods that have been successfully employed to ensure effective and efficient spending in virtual models. Vendor Management: Keeping Many Vendors on the Same Timeline April A. Dovholuk Clinical Research Manager, Clinical Operations, Millenium Pharmaceuticals The Right Resources at the Right Time: Building a Virtual Team Robert Gallato Chief Business Officer, Alnara Pharmaceuticals SESSION 399I 3:30 PM-5:00 PM LEVEL: • Room 103B CME credits offered PD/TR - PROFESSIONAL DEVELOPMENT/ TRAINING Training and Education of Pharmaceutical Physicians: Experiences from Different Regions SESSION CHAIRPERSON(S) Jean-Paul M.F. Deslypere, MD, PhD CEO, Aesculape Pte Ltd., Singapore The session will provide information about the current efforts to train and certify pharmaceutical physicians in the US and elsewhere. It will highlight the different possibilities for training and the role of professional organizations in organizing this. In addition, it will more specifically focus on the various approaches which are taken in the different continents. This session will also review the details of an Innovative Medicines Initiative in the EU and compare it with the situation in the US, Latin America, and Asia. Training and Education of Pharmaceutical Physicians: Experiences from Latin America Joao Massud, MD Executive Officer, Newco Trials Pesquisa Clinica, Ltda., Brazil Emerging Needs in Pharmaceutical Medicine Education: Is Harmonization Possible? Honorio Silva, DrMed President, Inter American Foundation for Clinical Research SESSION 399J 3:30 PM-5:00 PM LEVEL: • Room 140B PMI PDUs offered PM/FI 1 - PROJECT MANAGEMENT/ FINANCE What Makes a Project Manager Effective? SESSION CHAIRPERSON(S) Leigh Shultz, PhD, PMP Associate Project Director, Merck & Co., Inc. What defines effective project management in the pharmaceutical industry, given that more than nine out of ten R&D projects fail? Effective project managers are defined both by what they do and how they do it. This session will examine what truly great project managers do and what combination of skills they have that sets them apart from their peers. Survey Results: What Do the Data Say? Jayna Rose, PhD, PMP Director, Global Program Manager, Amgen Inc. Large Pharma Perspective Leigh Shultz, PhD, PMP Project Leader, Bone and Pain, Merck & Co., Inc. Effective Project Management: A CRO Perspective Nita Ichhpurani, PMP Director, Drug Development, Development and Regulatory Services, MDS Pharma Services, Canada SESSION 399K 3:30 PM-5:00 PM LEVEL: • Room 154AB PMI PDUs offered PM/FI 2 - PROJECT MANAGEMENT/ FINANCE Six Sigma in Drug Development: The Good, the Bad, and the Ugly Experiences in Deployment SESSION CHAIRPERSON(S) Michael A. Walega, MSc Six Sigma Master Black Belt, Covance While the drug development industry is clearly not yet saturated in Six Sigma, the language and strategic importance of process excellence continue to grow and are already fairly common across a broad variety of organizations globally. Join us as we take a critical look at the accumulating reality and the lessons learned leveraging Six Sigma to optimize the complex process that is clinical trial conduct. The session addresses the experiences with Six Sigma deployment from complementary strategic and real-life practical perspectives. We will explore and expose lessons learned from various deployment models, share specific project case studies, and discuss the applicability of the methodology itself to our highly variable and complex industry. Panelists Daniel G. Rudmann, DVM, PhD Group Leader, Molecular Pathology and Imaging, Certified Lean/ Six Sigma Black Belt, Lilly Research Laboratories Debbie Profit, MS Associate Director, Clinical Operations, Global Clinical Development, Otsuka Pharmaceutical Development & Commercialization, Inc. Continuing Professional Training and Career Development of Pharmaceutical Physicians: Case Studies in China Representative Invited Medical Director, Wyeth Ltd., Hong Kong 109
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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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NOTES Monday, June 14 51
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TUESDAY, JUNE 15 7:00 am-5:30 pm SP
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