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Day One
Tuesday, November 13, 2007
7:30 am Conference Registration and Morning Coffee
8:30 Opening Workshop and Discussion
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Case Study-Based Workshop:
Identifying and Managing Pharmacovigilance Risk with a Business Partner |
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Facilitated by: Joanna L. C. May, Business Alliance Consultant, Global Product Safety, Eli Lilly and Company |
Objectives:
- Provide participants with framework, knowledge and skills to proactively assess and manage safety with a business partner
- Facilitate knowledge sharing, exchange of ideas and approaches to issues resolution with a business partner
Outline:
1. Introduction
- Why companies partner
- What are the expectations of your company when collaborating on a product? (Regulators, shareholders, patients, etc.)
- Review of regulations relating to licensing arrangements
2. Case Study
- Introduce mock partnership to be discussed and evaluated throughout workshop
3. Risk Evaluation & Due Diligence
- Additional pharmacovigilance risks are associated with partnering
- Due diligence - Identification/validation of these potential risks
- Due diligence themes
- Due diligence report assessment
4. Case Study
- Mock due diligence
- Select appropriate due diligence themes
- Develop mini-report
5. Implementation
- Action plan for implementation
- Capitalize on opportunities/partner strengths
- Mitigate risks
- Implementation Tools:
- License Agreement
- Safety or Regulatory Agreement
- Medical or Safety Committees
- Operational Committees
- Organized Project Teams for Special Needs
- Joint SOPs
- Alliance Metrics
- Periodic Assessments/Audits
6. Case Study
- Identify needs of mock alliance
- Propose appropriate tools for management
7. Ongoing Risk Management
- Operational metrics
- Informal, periodic assessment of processes and infrastructure, both joint and internal
- Periodic assessments and audits, both joint and internal
- Corrective action plans that address specific and systemic mitigation
8. Questions and Problem Solving
- Participants ask questions of presenter(s) and each other
- Current, specific scenarios may be raised by participants for group problem solving
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10:45 Close of Workshop and Morning Coffee Break
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KEYNOTES |
| 11:30 Structured Benefit-Risk Balance: Update on Industry Initiatives |
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John Ferguson, M.D., Vice President, Pharmacovigilance, Millennium Pharmaceuticals, Inc. |
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| 12:15 pm Integrating Drug Safety Knowledge Longitudinally Across a Compound’s Lifecycle as well as Across the Organization’s Entire Product Portfolio |
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Judith M. Sills, PharmD, Vice President, Medical Safety Operations, Integrated Medical Safety, Novartis
Pharmaceuticals Corporation |
The evolving safety landscape, prompted by product withdrawals, negative perception of the pharmaceutical industry, and increased regulatory requirements for risk management drives a need to be more proactive in the management of drug safety. Consequently, companies need to develop an integrated risk management approach from preclinical development through post-approval to enable identification, assessment, management, and communication of safety risks and optimization of benefits to patients.
- Developing an internal process and infrastructure to support benefit-risk assessment and global risk management planning
- Alignment of global pharmacovigilance SOPs
- Defining roles and responsibilities for benefit-risk assessment and risk management
- Improving business process in benefit-risk management
- Transitioning from clinical trial risk management to peri- and post-approval risk management
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1:00 Hosted Luncheon and Strategic Solutions Presentations
(Sponsorship Available)
| 2:15 Best Practice in Developing a Drug Safety Surveillance Program to Minimize Risk |
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Alan Goldberg, R.Ph., Director, Drug Safety Services, Periapproval, Covance, Inc. |
In today's environment of heightened awareness to drug risks, it is no longer an option for drug development companies to take a "wait and see" approach to drug safety. This presentation will focus on implementing best practice considerations in developing a drug safety surveillance program to minimize risks.
- Strategic alignment of drug safety services to meet pharmaceutical/biotech outsourcing
needs
- Identifying the most efficient and cost-effective options available
- Experience as CRO in providing adverse event data capture, tracking, review, processing to provide on-time regulatory submission reporting
- Meeting client needs consistently to develop continued working relationships
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| Case Study |
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| 2:45 Risk Management in Early Development: The Pre-Clinical/Clinical Safety Feedback Loop |
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Vivek Kadambi, Director, Drug Safety Evaluation, Millennium Pharmaceuticals, Inc. |
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John Ferguson, M.D., Vice President, Pharmacovigilance, Millennium Pharmaceuticals, Inc. |
- Optimizing the allocation of an organization’s scarce and increasingly costly drug safety assessment resources
- Aligning resources early to design and execute a proactive risk management plan
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3:15 Refreshment Break
3:45 Understanding Regulatory Authorities’ Evolving Drug Safety Risk Management Expectations and How They Should Be Applied in Practice
- Aligning risk management plans with an evolving regulatory environment
- Clarify the effect of the FDA risk management guidances and the European Clinical Trial Directive
- Understand multinational risk management approaches and initiatives from FDA, EMEA, MHLW and ICH
- Review practical approaches and new thinking from CIOMS VI and VII projects on clinical trial safety management
4:15 Implementing Pharmacovigilance Programs that Yield the Greatest Possible ROI in Terms of Both Increasing the Probability of Timely Approval and Mitigating Known and Unknown Safety Risks
- Costs and opportunities of Phase IV risk management programs
- Identifying how your risk management plans can be utilized as a new promotion tool
- How marketing can make best use of post-approval study findings
- Meeting marketing objectives through effective dissemination of trial data
- Examining successful implementations of effective drug safety initiatives
| 4:45pm Costs and Opportunities of Phase IV Risk Management Programs |
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- Jill E. Robinson, Vice President, Global Safety Surveillance & Epidemiology, Wyeth Research
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- Patrick M. Caubel, M.D., MBA, AVP, Head, Pharmacovigilance North America, sanofi-pasteur
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- Jan Willem van der Velden, M.D., Senior Vice President, Global Safety and Pharmacovigilance, PharmaNet
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- Gerald Faich, M.D., MPH, FISPE, Senior Vice President, Epidemiology and Risk Management, United BioSource Corporation
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5:30 Networking Reception (Sponsorship Available)
6:30 Close of Day One
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