Pharmacovigilance and Risk Management Strategies 2012 January 23-25, 2012 Tutorials: January 22, 2012 Sheraton National Hotel, Arlington, VA, USA PROGRAM CHAIRPERSON Mariette Boerstoel-Streefland, MD, MBA, MS(epi) Chief Safety Officer, Vice President Global Drug Safety Forest Research Institute, a Subsidiary of Forest Laboratories Inc. PROGRAM COMMITTEE Jean-Pierre Clement, MD Vice President and Head of International Pharmacovigilance Global Medical Safety Johnson & Johnson Pharmaceutical R&D William W. Gregory Senior Director, Safety and Risk Management, Pfizer Inc. Principal, SJ Pharma Consulting, Chairperson for Clinical Safety and Pharmacovigilance SIAC Eli Lilly & Company Ltd., United Kingdom Melissa M. Truffa, RPh Associate Director Office of Surveillance and Epidemiology/Division of Pharmacovigilance II, CDER, FDA Shinya Yamauchi Operating Officer, Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd., Japan who should attend Professionals involved in: Pharmacovigilance Risk Management Medical Product Safety Assessment Regulatory Affairs Clinical Research Data Analysis Pharmacoepidemiology Labeling Quality Assurance/Quality Control Compliance Medical Information Worldwide Headquarters Drug Information Association, Inc. 800 Enterprise Road, Suite 200 Horsham, PA 19044, USA Regional Offices Basel, Switzerland Tokyo, Japan Mumbai, India Beijing, China New Insights Into the Current Issues and Associated Challenges Impacting Drug Safety. Top pharmaceutical, biotech, and regulatory representatives will discuss the current complexities and controversies in pharmacovigilance and risk management throughout all phases of development and marketed use, new and updated legislation in various ICH regions, important new harmonization initiatives, life cycle management, the impact of social media, biosimilars, and the use of other data sources and observational research. This program will focus primarily on drug products and biologics. The Program is Organized as one day of Tutorials Followed by Three Days of Topical Presentations TUTORIALS Signal Detection, Case Assessment and Data Mining in Pharmacovigilance: Current State of the Art Development Safety Update Reports (DSURs): Principles and Practicalities Pharmacovigilance and Risk Management Planning Optimization and Improving Operational Performance FEATURED TOPICS Regulatory Day New European, US, and Japanese Legislation New Harmonization Initiatives Risk Management/Life Cycle Management REMS Translating Pre-clinical Findings into Human Use Benefit-risk Optimization Social Media Pharmacoepidemiology This meeting has been developed by the Clinical Safety and Pharmacovigilance Special Interest Area Community (SIAC)
2 continuing education credits This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Postgraduate Institute for Medicine (PIM) and the Drug Information Association. PIM is accredited by the ACCME to provide continuing medical education for physicians. PIM designates this live activity for a maximum of 21.75 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity. The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for up to 21.75 contact hours or 2.175 continuing education units (CEU s). Type of Activity: Knowledge Corexcel is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center s Commission on Accreditation. Corexcel designates this activity for a maximum of 25 contact hours. Drug Information Association has been approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 8405 Greensboro Drive, Suite 800, McLean, VA 22102; (703) 506-3275. Drug Information Association is authorized by IACET to offer 2.5 CEUs for this program. If you would like to receive a statement of credit, you must attend the program and tutorial(s), if applicable, scan your name badge at the DIA registration desk each day of the program and tutorial(s) you attend and complete the on-line credit request process through My Transcript at www.diahome. org. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on February 8, 2012. Please Note: If you are interested in receiving ACPE or IACET credit and do not scan your name badge each day of the program or tutorial(s) if applicable, you will not receive CE credit as partial credit will not be awarded. In order to obtain credit, you must attend the program or tutorial(s) in its entirety. Program Learning Objectives At the conclusion of this meeting, participants should be able to: Describe the latest regulatory framework for pharmacovigilance in the US, Europe, and Japan Discuss new safety harmonization initiatives Describe best practices for improving risk management and life cycle management approaches Discuss how companies are using social media to investigate safety information in the context of regulatory obligations Explain how to use other data sources and observational research for effective safety analysis Disclosure Policy The Postgraduate Institute for Medicine (PIM) and DIA require instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted by PIM and DIA for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations. CONTINUING EDUCATION CREDIT ALLOCATION Tutorial #1 - Signal Detection, Case Assessment and Data Mining in Pharmacovigilance: Current State of the Art: 3.25 nursing contact hours;.3 IACET CEUs Tutorial #2 - Development Safety Update Reports (DSURs): Principles and Practicalities: 3.25 nursing contact hours;.3 IACET CEUs Tutorial #3 - Pharmacovigilance and Risk Management Planning: 286-000-12-002-L04-P: 3.25 pharmacy contact hours or.325 CEUs; 3.25 nursing contact hours;.3 IACET CEUs Tutorial #4 Optimization and Improving Operational Performance: 3.25 AMA PRA Category 1 Credit(s) TM ; 3.25 nursing contact hours;.3 IACET CEUs Program: January 23-25, 2012 CME: 18.5 AMA PRA Category 1 Credit(s) TM Nursing: 18.5 contact hours IACET: 1.9 CEUs Pharmacy: January 23, 2012; 286-000-12-003-L04-P; 7 contact hours or.7 CEUs January 24, 2012; 286-000-12-004-L04-P; 6.5 contact hours or.65 CEUs January 25, 2012; 286-000-12-005-L04-P; 5 contact hours or.5 CEUs This program is part of DIA Certificate Program and is awarded the following: Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units For more information go to www.diahome.org/certificateprograms Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinionand not necessarily that of the organization they represent, or that of the Drug Information Association. Speakers and agenda are subject to change without notice. Recording of any DIA tutorial/workshop information in any type of media, is prohibited without prior written consent from DIA. TUTORIALS Four half-day preconference tutorials will address basic and introductory information on the following topics: 1. Signal Detection, Case Assessment and Data Mining 2. Development Safety Update Reports (DSURs) 3. Pharmacovigilance and Risk Management Planning 4. Optimization and Improving Operational Performance Sunday, January 22, 2012 8:30 am-12:00 pm Tutorial #1 (Half Day) Signal Detection, Case Assessment and Data Mining in Pharmacovigilance: Current State of the Art Sally Van Doren, PharmD President & Chief Executive Officer BioSoteria, Inc. Sheila Weiss Smith, PhD, MS, FISPE Director, Center for Drug Safety Professor, Pharmaceutical Health Services Research Department University of Maryland School of Pharmacy Professor, Epidemiology and Preventative Medicine University of Maryland School of Medicine Overview: This tutorial will provide a review and practical application of data mining techniques to safety surveillance, its application in signal detection, and the critical role of clinical case assessment. An overview of strategies and specific case studies will be presented. Learning Objectives: Recognize the basic concepts of data mining and principles of signal detection
3 Identify specific applications of data mining technology Explain the role of clinical case assessment in signal evaluation Describe the strengths and limitations of data mining in performance high-quality pharmacovigilance Target Audience: This tutorial is designed for clinical safety professionals involved in the areas of pharmacovigilance, pharmacoepidemiology, regulatory affairs, quality assurance, medical product safety assessment, and labeling. 1:30-5:00 pm Tutorial #2 (Half Day) Development Safety Update Reports (DSURs): Principles and Practicalities Eli Lilly & Company Ltd., UK Barry Arnold, MBBCh, FRCA, FFPM EU QPPV, Astra Zeneca, UK Michael Richardson International Head GPV&E and EU QPPV Bristol-Myers Squibb Overview: The new ICH E2F guideline on the Development Safety Update Report (DSUR) was signed off in August 2010 and came into force in Europe in September 2011. This new report will replace the current European clinical trial Annual Safety Report and, in the other ICH regions is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study. Learning Objectives: Discuss the main principles defined in the ICH E2F guideline Describe the structure and content of the DSUR Discuss on how a DSUR can be prepared Prepare for the implementation of the DSUR Target Audience: This tutorial is designed for sponsors of clinical trials, regulatory affairs staff of pharmaceutical companies, pharmacovigilance staff of pharmaceutical companies, and clinical development staff. 8:30 am-12:00 pm Tutorial #3 (Half Day) Pharmacovigilance and Risk Management Planning William W. Gregory Senior Director, Safety and Risk Management Pfizer Inc. Robert Sharrar, MD Executive Director, Safety, Epidemiology, Registries and Risk Management United BioSource Corporation Overview This tutorial will cover basic approaches to risk management planning in the regulatory framework of the EU, Japan, and the US. The various components of Risk Management Plans, Risk Minimization Plans, Risk Evaluation and Mitigation Strategies for identified and potential risks will be covered. Learning Objectives: Discuss similarities and differences in the risk management planning in the three ICH regions Describe the differences between identified and potential risks Outline the basic structure and content of an EU Risk Management Plan and a Risk Evaluation and Mitigation Strategy Discuss primary tools for managing product risk and triggers for their modification or elimination Target Audience: This tutorial is designed for those in clinical safety and risk management, regulatory affairs, and post-authorization research, particularly those with responsibility for practical aspects of managing product risks in the context of the product s benefits. 1:30-5:00 pm Tutorial #4 (Half Day) Optimization and Improving Operational Performance Principal, SJ Pharma Consulting, Chairperson for Clinical Safety and Pharmacovigilance SIAC Ram Mohan Management Consultant, Life Sciences Centerline Partners LLP Overview This tutorial will describe how to assess and optimize pharmacovigilance operations from cost effective, compliance, and safety perspectives. A structured methodology for assessing drug safety operations will be presented. This will include recognizing the need to conduct process analysis, developing and prioritizing project portfolio, performing the analysis, and finally implementing the findings. The methodology has helped companies increase compliance at reduced cost. The scope covers all pharmacovigilance activities: case processing activities such as case intake, data entry, assessment and reporting, and signaling activities such as signal detection, evaluation and risk management. Learning Objectives Assess current pharmacovigilance environment case processing and signaling Identify areas of improvements redundancies, automating manual intensive operations, over/under inspections Implement metrics and organization change management, including critical success factors Identify obstacles to implementation Evaluate pros and cons of outsourcing/off-shoring Target Audience This tutorial is designed for those in clinical safety/pharmacovigilance, quality management, and clinical research & development. Day 1 Monday, January 23, 2012 7:30-8:30 am continental Breakfast and Attendee Registration 8:30-8:45 am Welcome and Opening Remarks Program Chairperson Mariette Boerstoel-Streefland, MD, MBA, MS(epi) Chief Safety Officer, VP Global Drug Safety, Forest Research Institute, Forest Laboratories Inc. SIAC Chair Principal, SJ Pharma Consulting; Chairperson for Clinical Safety and Pharmacovigilance Special Interest Area Community (SIAC) 8:45-9:30 am Keynote Presentation The Six Challenges and Opportunities of Safety Risk Management in a Global, Transparent, And Litigious World Philippe Van der Auwera, MD, PhD Global Head of Safety Risk Management F. Hoffmann-La Roche Ltd., Switzerland
4 9:30-10:00 am REFRESHMENT BREAK 10:00 am-12:00 pm Session 1 Regulatory Updates Eli Lilly & Company Ltd., UK 10:00-11:00 am EU Update 11:00-11:30 am US Update New Safety Regulations Gerald J. Dal Pan, MD, MHS Director, Office of Surveillance and Epidemiology, CDER, FDA Linda Scarazzini, RPh, MD Director, Division of Pharmacovigilance I, CDER, FDA 11:30 am-12:00 pm New IND Regulations Mwango Kashoki, MD Medical Officer, Office of New Drugs, CDER, FDA 12:00-1:00 pm Luncheon 1:00-3:15 pm Session 2 Regulatory Updates (Continued) E. Stewart Geary MD Vice President and Head of Global Pharmacovigilance Eisai Co., Ltd. 1:00-1:30 pm Japan Update Junko Sato, PhD Director for Risk Management, Office of Safety II Pharmaceuticals and Medical Devices Agency (PMDA), Japan 1:30-2:00 pm Asia Pacific Update E. Stewart Geary MD Vice President and Head of Global Pharmacovigilance Eisai Co., Ltd. 2:00-2:30 pm Latin America Update Marta C. V. Avellar Pharmacovigilance Manager Latin America Global Pharmacovigilance and Risk Management Shire 2:30-3:15 pm Ask the Experts Question and Answer Panel Discussion 3:15-3:45 pm Refreshment Break 3:45-5:15 pm Session 3 Social Media Edwin J. Tucker, BSc, MB ChB, MRCP, MBA VP, Head of PV Operations, Global Medical Safety Janssen Research & Development 3:45-4:30 pm Social Media Web-Based Media as an Opportunity to Create New Insights Into Medicinal Products Edwin J. Tucker, BSc, MB ChB, MRCP, MBA VP, Head of PV Operations, Global Medical Safety Janssen Research & Development 4:30-5:15 pm AE Reporting in the Era of Web 2.0: The Challenges of Having a Two- Way Conversation Elizabeth E. Garrard, PharmD, RPh Chief Safety Officer, Drug Safety Alliance 5:15-5:30 pm Day 1 Summary 5:30-6:30 pm NETWORKING RECEPTION Day 2 Tuesday, January 24, 2012 7:30-8:30 am Registration and Continental Breakfast 8:30-10:00 am Session 4 Benefit Risk Optimization William W. Gregory Senior Director, Safety and Risk Management Pfizer Inc. 8:30-9:00 AM FDA Perspective: What Are We Learning from the Evaluation of REMS Mary Willy, PhD Deputy Director, Division of Risk Management Office of Medication Error Prevention and Risk Management, CDER, FDA 9:00-9:30 am Tools: CIOMS IV, Value/Endpoints/Effectiveness Meredith Y. Smith Senior Scientific Director, Risk Management Abbott Laboratories Global Pharmaceutical Research & Development 9:30-10:00 am Integrated Evaluation of REMS/Risk Minimization Swapu Banerjee, DM, MSc, MBA, MFPM, FRCP, FRCS, FAcadMEd, FSB Board Member and Head of Risk Management, Drug Safety & Regulatory, Pope Woodhead, UK Faculty Member, Institute of Biotechnology, University of Cambridge 10:00-10:30 am Refreshment Break 10:30 am-12:00 pm Session 5 Risk Management Jean-Pierre Clement, MD Vice President and Head of International Pharmacovigilance Global Medical Safety Division of Johnson & Johnson Pharmaceutical R&D 10:30-11:00 am EU Risk Management: What Changes Will the New PV Legislation Bring? 11:00-11:30 am Post Authorization Safety Studies and The Impact on New EU PV Legislation Saad Shakir Director, DSRU 11:30 am-12:00 pm Patient s Like Me: Patient Perspective on Risk Management Sally Okun, RN, MMHS Health Data Integrity & Patient Safety Patient s Like Me
5 12:00-1:00 pm Luncheon 1:00-2:30 pm Session 6 Pharmcoepidemiology Mariette Boerstoel-Streefland, MD, MBA, MS(epi) Chief Safety Officer, Vice President Global Drug Safety, Forest Research Institute Forest Laboratories Inc. 1:00-1:30 pm Results on ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance) 1:30-2:00 pm Results on Mini-sentinel Marsha Reichman Senior Advisor Office of Surveillance and Epidemiology, CDER, FDA 2:00-2:30 pm How FDA uses Epidemiology Data to Arise at Conclusions Tarek A. Hammad, MD, PhD, MSc, MS Deputy Division Director, Division of Epidemiology-I CDER, FDA 2:30-3:00 pm Refreshment Break 3:00-4:30 pm Session 7 Do and Don ts Mock Deposition Shinya Yamauchi Operating Officer, Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd., Japan Product Liability, Historical Overview and Mock Deposition 3:00-4:30 pm Product Liability, Historical Overview and Mock Deposition Richard F. Kingham, Esq Partner, Covington & Burling LLP 4:30-5:00 pm Day 2 Summary and Wrap Up Day 3 Wednesday, January 25, 2012 7:30-8:30 am Registration and Continental Breakfast 8:30-10:00 am Session 8 Translating Pre-clinical Findings into Human Use John Ayres, MD Senior Medical Director Eli Lilly, US 8:30-9:00 am Weighing the Benefit Risk Lewis B. Kinter, PhD Senior Director, Regulatory Toxicology, Global Safety Assessment AstraZeneca Pharmaceuticals LP 9:30-10:00 am Ask the Experts Question and Answer Panel Discussion 10:00-10:30 am Refreshment Break 10:30 am-12:00 pm Session 9 Development Safety Update Reports (DSUR) Principal, SJ Pharma Consulting, Chairperson for Clinical Safety and Pharmacovigilance SIAC 10:30-11:00 am DSUR EU Perspective Barry Arnold, MBBCh, FRCA, FFPM EU QPPV, Astra Zeneca, UK 11:00-11:30 am DSUR US Perspective Ellis F. Unger Deputy Director Office of Drug Evaluation-I, Office of New Drugs, CDER, FDA 11:30 am-12:00 pm Ask the Experts Question and Answer Panel Discussion 12:00-1:00 pm Luncheon 1:00-2:30 pm Session 10 What s Hot, What s Not 1:00-1:30 pm E2C[R2]: From PSUR to Benefit Risk Evaluation Eli Lilly & Company Ltd., UK 1:30-2:00 pm New from Japan Hazuki Takaura, MS Reviewer, Office of Safety ll Pharmaceuticals and Medical Devices Agency (PMDA), Japan 2:00-2:30 pm Meta-Analyses of Clinical Data for Regulated Biopharmaceutical Products: Answers to Frequently Asked Questions Brenda Crowe, PhD Brenda Crowe, PhD Research Advisor, Global Statistical Sciences Eli Lilly and Company 2:30-3:00 pm Meeting Wrap Up and Closing 3:00 pm MEETING ADJOURNS 9:00-9:30 am Evaluation and Review of Study Protocols for Safety and Risk John Ayres, MD Senior Medical Director Eli Lilly, US
REGISTRATION FORM Register online or fax this page to +1.215.442.6199 Pharmacovigilance and Risk Management Strategies 2012 Event #12002 Tutorials: January 22 Conference: January 23-25, 2012 Sheraton National Hotel, Arlington, VA, USA Registration Fees If DIA cannot verify your membership, you will be charged the nonmember fee. Registration fee includes refreshment breaks, luncheons, and reception (if applicable), and will be accepted by mail, fax, or online. Member Early-bird Opportunity on or before After Available on nondiscount member fee only JAN. 2, 2012 JAN. 2, 2012 Member Fee US $1465 q US $1665 q Join DIA now to qualify for the early-bird member fee! MEMBERSHIP www.diahome.org/membership us $140 q To qualify for the early-bird discount, registration form and accompanying payment must be received by the date above. Does not apply to government/academia/nonprofit members. Nonmember Fee US $1805 q A one-year membership to DIA is available to those paying a nonmember registration fee. If paying a nonmember fee, please indicate if you do, or do not, want membership. I want to be a DIA member q I do NOT want to be a DIA member q Discount Fees MEMBER NONMEMBER Government (Full-time) US $665 q US $805 q Charitable Nonprofit/Academia (Full-time) US $835 q US $975 q *If paying a nonmember fee, please check one box above, indicating whether you want membership. To receive a tabletop exhibit application, please check Preconference Workshops, January 22, 2012 #1 Signal Detection, Case Assessment and Data Mining in Pharmacovigilance: Current State of the Art, 8:30 am-12:00 pm US $405 q #2 Development Safety Update Reports (DSURs): Principles and Practicalities, 1:30-5:00 pm US $405 q #3 Pharmacovigilance and Risk Management Planning, 8:30 am-12:00 pm US $405 q #4 Optimization and Improving Operational Performance, 1:30-5:00 pm US $405 q GROUP DISCOUNTS* Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia. To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA. q Please indicate that this form is part of a group registration by checking this box and list below the names of the other three registrants from your company. q TRAVEL AND HOTEL The most convenient airport is Ronald Reagan National Airport and attendees should make airline reservations as early as possible. The Sheraton National Hotel is holding a block of rooms at the reduced rate below until January 1, 2012, for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled. Single $175 Double $175 Attendees must make their own hotel reservations. Contact the Sheraton National Hotel by telephone at +1.800.325.3535 and mention the DIA event. The hotel is located at 900 South Orme Street, Arlington, VA 22204, USA. cancellation Policy: On or before january 15, 2012 Administrative fee that will be withheld from refund amount: Member or Nonmember = $200 Government or Academia or Nonprofit (Member or Nonmember) = $100 Tutorial (if applicable) = $50 Cancellations must be in writing and be received by the cancellation date above. Registrants who do not cancel by that date and do not attend will be respons ible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. You may transfer your registration to a colleague at any time but membership is not transferable. Please notify DIA of any such substitutions as soon as possible. Substitute registrants will be responsible for nonmember fee, if applic able. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants. Participants with Disabilities: DIA event facilities and overnight accommodations are accessible to persons with disabilities. Services will be made available to sensory-impaired persons attending the event if requested at least 15 days prior to event. Contact the DIA office to indicate your needs. Tabletop Exhibit information Attendees may visit the tabletop exhibits during the event and receptions. Contact Jeff Korn, Exhibits Associate, Phone +1.215.442.6184 Fax +1.215.442.6199, email Jeff.Korn@diahome.org event information Contact Ellen Diegel, Program Manager, Phone +215-293-5810 Fax +1.215.442.6199, email Ellen.Diegel@diahome.org Please check the applicable category: q Academia q Government q Industry q CSO q Student (Call for registration information) Last Name 1. 2. First Name M.I. 3. 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