1. 2nd
Global Pharmacovigilance
& Adverse Event Reporting
Navigating Global Regulations and Reporting Requirements
to Build Proactive Risk Management Strategies
and Mitigate Potential Safety Concerns
May 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 cuts
Pre-Conference Workshop: May 22, 2012 have forced life sciences companies to streamline operations
Workshop: 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 Pharmacovigilance
Conference Chairperson: Experts Including:
Reinerio A. Deza, MD
Head, 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 Montreal
Attending this Premier marcus evans Management & Epidemiology Hospital Centre
Biogen Idec Sanofi
Conference 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 Pharmacovigilance
marcus 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 Pharmaceuticals
Cocktail Sponsor: Media Partners:

2. Pre-Conference Workshop | May 22, 2012
1:30 Registration 11:45 Interactive Roundtable Discussion
Reviewing New EU Pharmacovigilance Rules to Better Facilitate Early Discovery
2:00 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 become
Drug safety has become an even greater priority for drugmakers as new regulations from the single portal of pharmacovigilance information in the EU
across 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 includes
patient safety. Companies are reassessing their pharmacovigilance departments to ensure a scientific evaluation of the product’s risk/benefit balance
they have the right people, tools and systems to achieve their goals and appropriately • Promoting transparency to encourage patients to report potential adverse reactions
manage 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 Study
Paul Beninger, MD, FACP, Vice President, Global Patient Safety
Sanofi Evaluating Effectiveness Strategies to Gain a Global View
of Risk Management Plans
4:00 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 Idec
Day One | May 23, 2012 2:15 Case Study
From Risk Management to Benefit-Risk Management: The Emerging Role
8:30 Registration & Morning Coffee of Global Safety Leads
• Understanding the regional requirements and differences in risk tolerance
8:50 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 TECHNIQUES
9:00 Case Study TO IMPROVE DECISION-MAKING
Evaluating New and Pending Global Pharmacovigilance Regulations
to 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 also
Robin Geller, PhD, Director of Pharmacovigilance Intelligence and Safety Writing, post-approval resources
Global Pharmacovigilance • Assessing upcoming or new regulations regarding insurance companies’ claims
Baxter Healthcare data being utilized as mining sites for pharmaceutical companies
Ken Hornbuckle, Senior Epidemiology Advisor, Office of Risk Management
9:45 Interactive Panel Discussion and Pharmacoepidemiology, Global Patient Safety
Exploring Periodic Safety Update Reports (PSUR) and New Risk Eli Lilly
Management-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 process
Panelists:
Robin Geller, PhD, Director of Pharmacovigilance Intelligence and Safety Writing,
Global Pharmacovigilance
Baxter Healthcare Corporation
Steven Du, MD, PhD, Senior Director, Pharmacovigilance & Pharmcoepidemiology
AMAG Pharmaceuticals
10:30 Networking Break
11:00 Case Study
Evaluating New Requirements and the Effectiveness of Risk Evaluation
and 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 industry
Yola Moride, PhD, FISPE, Associate Professor, Faculty of Pharmacy
University of Montreal Hospital Centre
More Registration Details, Click Here

3. Day Two | May 24, 2012
8:30 Registration & Morning Coffee 1:45 Joint Case Study
Evaluating Drug Safety Outsourcing Options to Meet the Company's Needs
8:50 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 Pharmaceuticals
9:00 Case Study
Identifying 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 Study
Shailesh Chavan, MD, Senior Director, Clinical Research, Medical Affairs & Drug Safety Going Beyond the Initial Signal Detection to Form a Robust Action
Biotest Pharmaceuticals Corporation and Improvement Plan
• Reviewing visualization tools to assist with signal detection and the shift from
9:45 Case Study 2D to 3D technology
Exploring 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 data
Steven Du, MD, PhD, Senior Director, Pharmacovigilance & Pharmcoepidemiology 3:15 Closing Remarks of the Chair & End of Conference
AMAG Pharmaceuticals
10:30 Networking Break
11:00 Case Study
Utilizing 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 reactions
Veronique Kugener, MD, MSc, MBA, Vice President, Pharmacovigilance and Risk Management
Millennium: The Takeda Oncology Company
Chris Sanders, Manager, Pharmacovigilance & Risk Management
Millennium: The Takeda Oncology Company
Pat Connelly, Associate Director, Digital Strategy and Communications
Millennium: The Takeda Oncology Company
12:00 Luncheon
IDENTIFYING INTERNAL MEASURES TO IMPROVE DRUG SAFETY
1:00 Case Study
Overcoming 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 budget
Patrick Caubel, MD, PhD, MBA, Vice President, Global Head,
Global Pharmacovigilance & Epidemiology
Sanofi
PRODUCER INFO
I would like to thank everyone who has assisted with the research and organization
of the event, particularly the speakers for their support and commitment. Sarah Michalos
Conference 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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