2ndGlobal Pharmacovigilance& Adverse Event ReportingNavigating Global Regulations and Reporting Requirementsto Build Proac...
Pre-Conference Workshop | May 22, 20121:30    Registration                                                                ...
Day Two | May 24, 20128:30     Registration & Morning Coffee                                                         1:45 ...
COCKTAIL SPONSOR:Medpace is a leading global full-service clinical research organization providing Phase I-IV core develop...
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2nd Global Pharmacovigilance & Adverse Event Reporting Conference


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2nd Global Pharmacovigilance & Adverse Event Reporting Conference

  1. 1. 2ndGlobal Pharmacovigilance& Adverse Event ReportingNavigating Global Regulations and Reporting Requirementsto Build Proactive Risk Management Strategiesand Mitigate Potential Safety ConcernsMay 22-24, 2012 “ Strengthen data mining,Le Meridien Cambridge | Cambridge, MA More Registration Details, Click Here! REMS and signal detection tactics in a changing drug safety landscape. ” Recently approved global regulations coupled with budget cutsPre-Conference Workshop: May 22, 2012 have forced life sciences companies to streamline operationsWorkshop: Looking to the Future of Global Drug Safety while still placing priority on drug safety functions.to Mitigate Liability with Sanofi Featuring Case Studies from Leading PharmacovigilanceConference Chairperson: Experts Including:Reinerio A. Deza, MDHead, Global Pharmacovigilance Carmen Bozic Patrick Caubel, MD, Yola Moride, PhD, FISPE Senior Vice President PhD, MBA Associate Professor,Cubist Pharmaceuticals and Global Head, Vice President, Global Head, Faculty of Pharmacy Safety and Benefit-Risk Global Pharmacovigilance University of MontrealAttending this Premier marcus evans Management & Epidemiology Hospital Centre Biogen Idec SanofiConference Will Enable You To: Steven Du, MD, PhD• Hear about the latest global regulations regarding drug safety Robin Geller, PhD Paul Beninger, MD, FACP Senior Director, and the proper reporting of adverse events Director of Pharmacovigilance Vice President, Pharmacovigilance• Share best practices with industry leaders with robust drug Intelligence and Safety Writing, Global Patient Safety & Pharmcoepidemiology Global Pharmacovigilance Sanofi AMAG Pharmaceuticals safety and risk management strategies Baxter Healthcare• Take home techniques to best protect the company Corporation Shailesh Chavan, MD Chris Sanders from adverse events and ensure compliance if they do occur Senior Director, Clinical Manager, Pharmacovigilance• Explore strategies regarding REMS and signal detection to Veronique Kugener, Research, Medical Affairs & Risk Management strengthen existing internal procedures MD, MSc, MBA & Drug Safety Millennium: The Takeda Vice President, Biotest Pharmaceuticals Oncology Company• Overcome challenges not only in post-marketing safety but Pharmacovigilance Corporation also challenges specific to clinical safety and Risk Management Michie Hisada, MD, Millennium: The Takeda Pat Connelly MPH, ScD Oncology Company Associate Director, Medical Director,Who Should Attend: Digital Strategy Pharmacovigilancemarcus evans invites Vice Presidents, Directors and Managers Ken Hornbuckle and Communications Takeda Global Research &within the pharmaceutical and biotechnology industries with Senior Epidemiology Advisor, Millennium: The Takeda Development Center, Inc.responsibilities in: Office of Risk Management and Oncology Company• Pharmacovigilance • Signal Detection Pharmacoepidemiology, Global Patient Safety Reinerio A. Deza, MD• Drug Safety/Risk • REMS Eli Lilly Head, Global Management • Safety Surveillance Pharmacovigilance• Pharmacoepidemiology • Phase IV/ Naghmana Bajwa Cubist Pharmaceuticals• Drug/Product Safety Post-Marketing Studies Senior Director, Global• Clinical Safety • Medical Director/ Pharmacovigilance Wendy Gustafson• Chief Safety Officer Medical Affairs & Risk Management Senior Manager,• Patient/Medical Safety Shire Human Pharmacovigilance Genetic Therapies Cubist PharmaceuticalsCocktail Sponsor: Media Partners:
  2. 2. Pre-Conference Workshop | May 22, 20121:30 Registration 11:45 Interactive Roundtable Discussion Reviewing New EU Pharmacovigilance Rules to Better Facilitate Early Discovery2:00 Pre-Conference Workshop of Adverse Reactions (ARs)Looking to the Future of Global Drug Safety to Mitigate Liability • Understanding the role of the existing Eudravigilance database to becomeDrug safety has become an even greater priority for drugmakers as new regulations from the single portal of pharmacovigilance information in the EUacross the globe are being implemented in an effort to streamline reporting and improve • Preparing for a more detailed periodic safety report to the EMA that includespatient safety. Companies are reassessing their pharmacovigilance departments to ensure a scientific evaluation of the product’s risk/benefit balancethey have the right people, tools and systems to achieve their goals and appropriately • Promoting transparency to encourage patients to report potential adverse reactionsmanage risk in the future. Attending this workshop will enable to you to: to the proper authority in a timely manner• Identify pending regulations to help begin the internal preparation process• Prioritizing planned improvements based on compliance and overarching 12:30 Luncheon company goals• Engaging upper management in an effort to stress the importance of the drug EXPLORING GLOBAL PHARMACOVIGILANCE ADVANCES safety function and a focus on patient safety• Benchmarking with other companies to identify strengths and areas for improvement 1:30 Case StudyPaul Beninger, MD, FACP, Vice President, Global Patient SafetySanofi Evaluating Effectiveness Strategies to Gain a Global View of Risk Management Plans4:00 End of Pre-Conference Workshop • Deciphering formal measures of effectiveness in Europe and how to achieve validated tools to standardize measurement techniques • Going beyond the action plan to measure how your strategy works and how to report to authorities • Reviewing the latest update on the FDA’s intention to strengthen effectiveness checks and how to incorporate this consideration into the overall risk management plan Carmen Bozic, Senior Vice President and Global Head, Safety and Benefit-Risk Management Biogen IdecDay One | May 23, 2012 2:15 Case Study From Risk Management to Benefit-Risk Management: The Emerging Role8:30 Registration & Morning Coffee of Global Safety Leads • Understanding the regional requirements and differences in risk tolerance8:50 Chairperson’s Opening Address • Facilitating global alignment of unified PV strategy Reinerio A. Deza, MD, Head, Global Pharmacovigilance • Expanding functional and cross-functional role with accountability within Cubist Pharmaceuticals global development team Michie Hisada, MD, MPH, ScD, Medical Director, Pharmacovigilance Takeda Global Research & Development Center, Inc. OVERVIEW OF CURRENT PHARMACOVIGILANCE 3:00 Networking Break REGULATIONS TO ENSURE COMPLIANCE RELYING ON DATA MINING TECHNIQUES9:00 Case Study TO IMPROVE DECISION-MAKINGEvaluating New and Pending Global Pharmacovigilance Regulationsto Ensure Compliance 3:30 Case Study• Customizing an overall company drug safety plan while still adhering to local Illustrating Advances and Regulatory Challenges in Data Mining Strategies and regional regulations • Utilizing medical databases and published studies to unearth potential drug side• Creating a continuity plan to ensure pending regulations are monitored effects and improve decision-making and addressed in drug safety plans • Establishing data mining techniques for mid-sized companies without large• Discussing increased harmonization of pharmacovigilance rules through budgets or manpower the implementation of ICH guidelines • Discussing approaches for analyzing safety data from clinical and alsoRobin Geller, PhD, Director of Pharmacovigilance Intelligence and Safety Writing, post-approval resourcesGlobal Pharmacovigilance • Assessing upcoming or new regulations regarding insurance companies’ claimsBaxter Healthcare data being utilized as mining sites for pharmaceutical companies Ken Hornbuckle, Senior Epidemiology Advisor, Office of Risk Management9:45 Interactive Panel Discussion and Pharmacoepidemiology, Global Patient SafetyExploring Periodic Safety Update Reports (PSUR) and New Risk Eli LillyManagement-Related Changes• Exploring new PSUR requirements that need to be dissected, especially risk 4:15 Closing Remarks of the Chair Followed by management-based considerations a Cocktail Reception Sponsored By:• Assessing the updates from the FDA regarding when additional regulations are expected and how they will impact the industry• Reviewing the submission process for PSURs and benchmarking with other companies currently in the submission processPanelists:Robin Geller, PhD, Director of Pharmacovigilance Intelligence and Safety Writing,Global PharmacovigilanceBaxter Healthcare CorporationSteven Du, MD, PhD, Senior Director, Pharmacovigilance & PharmcoepidemiologyAMAG Pharmaceuticals10:30 Networking Break11:00 Case StudyEvaluating New Requirements and the Effectiveness of Risk Evaluationand Mitigation Strategies (REMS) in its Current State• Analyzing REMS submission guidelines and what the FDA expects from companies• Reviewing the new spring 2012 REMS access program and its goal of easing the burden on health care systems• Sharing experiences beyond launching REMS, such as the implementation and follow-up process• Discussing key recommendations from the World Health Organization (WHO) working group regarding the effectiveness of REMS and potential impact on the industryYola Moride, PhD, FISPE, Associate Professor, Faculty of PharmacyUniversity of Montreal Hospital Centre More Registration Details, Click Here
  3. 3. Day Two | May 24, 20128:30 Registration & Morning Coffee 1:45 Joint Case Study Evaluating Drug Safety Outsourcing Options to Meet the Companys Needs8:50 Chairperson’s Opening Address • Understanding the pressures to complete more tasks with fewer resources Reinerio A. Deza, MD, Head, Global Pharmacovigilance and also continue to remain compliant Cubist Pharmaceuticals • Overcoming fears that outsourcing a portion of the company’s projects will create a loss of jobs DRAWING DRUG SAFETY STRATEGIES FROM DIFFERENT • Identifying the balance between in-house, external and alliance-based responsibilities GLOBAL MARKETS AND INDUSTRIES • Discussing benefits and drawbacks to an entirely outsourced drug safety function Reinerio A. Deza, MD, Head, Global Pharmacovigilance Cubist Pharmaceuticals9:00 Case StudyIdentifying Srategies and Planning Proactively for REMS Implementation Wendy Gustafson, Senior Manager, Pharmacovigilance• Considering best practices and planning for maximising returns on REMS strategies Cubist Pharmaceuticals• Ensuring close communication and planning with internal and external stakeholders• Maximizing product launch planning and lifecycle management 2:30 Case StudyShailesh Chavan, MD, Senior Director, Clinical Research, Medical Affairs & Drug Safety Going Beyond the Initial Signal Detection to Form a Robust ActionBiotest Pharmaceuticals Corporation and Improvement Plan • Reviewing visualization tools to assist with signal detection and the shift from9:45 Case Study 2D to 3D technologyExploring the Global Impact of New Pharmacovigilance Regulations in China • Understanding the process of internally dealing with the signal, communicating• Reviewing the new regulations for individual case safety reports in China with authorities and following up on the report and its implications to domestic and global manufacturers • Incorporating a breakdown of actions to take post-signal detection• Understanding the requirements for periodic safety reports in China and the • Adopting an ongoing review of the signal detection process to ensure difference from other regions efficiency and improvement• Discussing the current practice for spontaneous reporting of adverse events in China Naghmana Bajwa, Senior Director, Global Pharmacovigilance & Risk Management• Discovering the opportunities in establishing patient/disease registries in China Shire Human Genetic Therapies with access to the quality patient population and quality dataSteven Du, MD, PhD, Senior Director, Pharmacovigilance & Pharmcoepidemiology 3:15 Closing Remarks of the Chair & End of ConferenceAMAG Pharmaceuticals10:30 Networking Break11:00 Case StudyUtilizing Social Media in Post-Marketing Drug Safety• Leveraging platforms such as YouTube, LinkedIn, Twitter and blogging to help promote transparency and education• Dissecting the FDA’s draft guidelines regarding social media for the pharmaceutical industry and the potential impact• Discussing the future of Adverse Event Reporting (AER) in a digital age with more patients becoming engaged and vocal through numerous platforms• Weighing the benefits and legal ramifications of launching an open forum where patients can report positive experiences or adverse reactionsVeronique Kugener, MD, MSc, MBA, Vice President, Pharmacovigilance and Risk ManagementMillennium: The Takeda Oncology CompanyChris Sanders, Manager, Pharmacovigilance & Risk ManagementMillennium: The Takeda Oncology CompanyPat Connelly, Associate Director, Digital Strategy and CommunicationsMillennium: The Takeda Oncology Company12:00 Luncheon IDENTIFYING INTERNAL MEASURES TO IMPROVE DRUG SAFETY1:00 Case StudyOvercoming Budget Challenges to Ensure Drug Safety Efforts Remain a Priority• Ensuring a robust, effective drug safety department amidst budget cuts• Relying on employees to gain new skills and take on additional roles to prevent the company from opening itself up to risks• Considering the option of outsourcing some or all of the drug safety function to ensure efficiency• Improving communication with the FDA or other agencies to keep up on regulation changes that could impact the department budgetPatrick Caubel, MD, PhD, MBA, Vice President, Global Head,Global Pharmacovigilance & EpidemiologySanofiPRODUCER INFOI would like to thank everyone who has assisted with the research and organizationof the event, particularly the speakers for their support and commitment. Sarah MichalosConference Producer, sarahm@marcusevansch.com. MARKETING INFO For more information regarding sponsorship, speaking or attending this conference please contact, Michele Westergaard , +1312 540 3000 ext. 6625 More Registration Details, Click Here
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