Organizing to Address the Global Risk Management Challenge

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1 Organizing to Address the Global Risk Management Challenge September 11, ParagonRx International LLC 2013 ParagonRx International LLC

2 Today s Session Organizing to Address the Global Risk Management Challenge Speaker: Brande Ellis Advisor of Risk Minimization in Global Patient Safety, Eli Lilly and Company ParagonRx International LLC

3 Today s Session Organizing to Address the Global Risk Management Challenge Highlights: Overview of the Global Risk Management Environment A case example of one company s approach Core Risk Management Plan Risk Management Coordinator Model ParagonRx International LLC

4 Risk Management Coordination Model Brande Ellis Eli Lilly and Company 4

5 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to ParagonRx, its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All other trademarks are the property of their respective owners. 5

6 Objectives Overview of the Global Risk Management Environment One company s approach Core Risk Minimization Plan Risk Management Coordinator Model 6

7 What is Risk Management? Risk Management = Risk Assessment + Risk Minimization Risk Assessment: Focus on a proactive, systematic and evidence driven approach to evaluating safety Need to understand what IS known about the safety profile, and Need to understand what is NOT known about the safety profile Risk Minimization: What will be done to ensure patient safety when important safety issues are identified Emphasis on providing evidence of safe use in light of the risks More than product labeling and routine pharmacovigilance requirements 7

8 Risk Management Plan 8

9 Global Risk Management Planning The Challenge of Reconciling the Differences Europe ICH E2E +/- Risk Minimization Plans US RM Guidelines including RiskMAP/REMs Japan ICH E2E + EPPV(?) 9

10 Examples: Regulatory Activity for Risk Management in ICH Countries ICH EU US Japan ICH E2E: Pharmacovigilance Planning Eudravigilance Database Implemented PDUFA III EPPV Introduced Guideline on Risk Management Systems for Medicinal Products for Human Use Template Volume 9A FDA Risk Management Guidance Documents FDA Amendments Act (FDAAA) FDA REMS Guidance Committee Based on Drug Disasters Safety Working Teams (ICHE2E, PI and AE Management, Electonic databases, ICH E2F: Developmental Safety Update Report ICH E2C (R2): Periodic Benefit-Risk Evaluation Report- Step 2 Guideline on Good Vigilance Practices FDAAA Guidance- Safety Labeling and Post-Marketing Studies PDUFA V 10

11 Risk Management Goal A reminder Verify that medicine s benefits exceed risks by the greatest achievable margin for the individual patient and target population as a whole 11

12 Perspectives of Risk Management SFDA BIO DIA Med Ed OLs HCPs Payers Pharmacists Institutions MLs Med Info ICH CADREAC Saudi Arabia 12

13 The Risk Minimization Plan (RMiP) Outlines specific measures beyond labelling to protect patients and minimize known risks. If required, these measures need to: Be appropriate to the level of risk Be feasible in practice Be effectively communicated Include input from all relevant functional areas Proposals to monitor success and report on effectiveness are required. Lilly has formalized the definition and approach to RMiP. Quality System Advisory/Governance Structure Coordination of activities Office of Risk Management and Pharmacoepidemiology 13

14 Application of Risk Minimization Activities Labeling Purpose: Establish B-R Profile Communication Elements Focus: Comprehensive for benefits and risks of the drug Application: All drugs Purpose: Reinforce Labeling Focus: Important Identified or Potential Risks Application: New clinical information, or new emphasis on current practice Safe Use Elements Purpose: Ensure Benefits Outweigh Risks Focus: Key Important Identified Risks Application: New clinical practice 14

15 EU RMP and REMS FDA Amendments Act of 2007 Title IX, Subtitle A (REMS) EU Good Pharmacovigilance Practices (GVP) Module V- Risk Management Systems Module VII- Periodic Safety Report DRAFT Module XVI Risk Minimisation Measures 15

16 Business Structure Development teams are responsible for drug development and marketing authorization status globally Safety is responsible for actively monitoring and communicating the safety profile of a drug Regulatory is responsible for engaging with regulators regarding drug development and marketing authorization Affiliates are responsible for providing post-marketing medical and commercial support of approved products Approval of affiliate RMA Affiliate Development Teams Affiliate Implementation of RMA 16

17 Approach to Risk Minimization Plans (RMiPs) Safety Team Safety Team Core Risk Management Plan Safety, Development, and affiliate Develop Region/ Affiliate RMiP Evaluate need Develop Core Risk Minimization Develop Region/ Affiliate RMiP Develop Region/ Affiliate RMiP 17

18 Designing the Core RMiP A proactive approach is considered, beginning early in clinical development. Safety, in conjunction with the development team, evaluates the need for Risk Minimization Activities (RMA) beyond labeling from a global product perspective. 18

19 Core Risk Minimization Plan Approval The Core RMiP is the standard for implementation around the world. It is critical for the RMiP Design Team to consider feasibility of regional/local implementation globally An advisory committee with members from safety, regulatory, legal, and development teams, is designed to enable consistency and feasibility of RMiP across the portfolio globally The Chief Medical Officer approves the core RMiP along with the Core Data Sheet Company Confidential Copyright 2012 Eli Lilly and Company 19

20 Impact to Submission and Approval The RMiP may be required for approval, particularly in US and EU The RMiP must meet local requirements and may require approval in conjunction with approval of the submission This can occur with NDA, NILEX, or new safety information Implementation of RMiP will likely involve multiple functions, thus require collaborative input to the design. Company Confidential Copyright 2012 Eli Lilly and Company 20

21 Approval of Local Risk Minimization Plans Approval of the RMiP requires alignment of Development Teams, Safety, and Regulatory, with consultation from legal A long-term commitment for implementation and evaluation of effectiveness requiring resources from multiple areas Company Confidential Copyright 2012 Eli Lilly and Company 21

22 Resourcing Model: Risk Management Coordinator (RMC) Safety has dedicated resources to facilitate the design, implementation, and assessment of RMiPs and specialized pharmacoepidemiology studies. The RMC group provides specialized patient safety expertise to plan, monitor and control implementation and reporting of observational studies to characterize risks and programs to minimize the most serious safety risks for patients globally 22

23 What Value Does the RMC Provide? Provide specialized patient safety expertise to plan, monitor and control implementation and reporting of programs to minimize the most serious safety risks for patients globally (Risk Minimization) observational studies to characterize risks (Specialized Pharmacoepidemiology Safety Studies) Responsible for organizing various aspects in the creation, implementation, and evaluation of Core and Regional Risk Minimization Strategies through the application of the discipline of Project Management. Use strong leadership and communication skills to influence and enable teams to achieve desired results. Build effective cross-functional relationships and partnerships with key stakeholders, including GRA, BU Development and Affiliates, and external parties. Establish RMC as the conduit for risk minimization information flow, including understanding of global risk minimization regulations, trends and changes in risk minimization approaches and impact to healthcare systems. Be a champion of change to enable necessary transformation; and drive internal and external shared learning to maximize the benefit of these changes leading to exceptional customer experiences. 23

24 Deliverables and Relationships Compliance Key Deliverables RMiPs (Core & Regional/Local) Implementation Plans for regional and affiliate Risk Minimization Activities Evaluation of effectiveness of RMiP activities Adaptation to evolving RMiP environment Timely and quality delivery of safety pharmacoepidemiology studies RMC 24

25 RMC Core Skills Risk Minimization Expertise: Understanding categorization of risks and how these translate to RMPs and RMiP beyond labeling Understanding of global risk minimization regulations and trends Understanding of the impact of risk minimization activities on the healthcare system to right-size RMiP activities Knowledge of vendor capabilities and assessment of capabilities to optimize implementation of RMiPs Application of the discipline of Project Management PMBOK- Integration, Scope, Quality, Communication, Risk, Procurement, HR, Time, Cost 25

26 RMC Core responsibilities: Project Initiation Initiate the core RMiP for Lilly compounds Partner with Safety and Benefit-Risk Management Scientist to understand the key risks of a medicine Work with Safety to develop the risk minimization activities in the initial Developmental Risk Management Plan (DRMP) Apply Failure Modes and Effects Analysis to identify appropriate risk minimization interventions Develop a project charter for core RMiP Engage stakeholders in planning the core RMiP 26

27 RMC Core responsibilities: Project Planning Plan effective implementation strategies for regional/local RMiPs and complex PE Studies Develop a project management plan to ensure coordination of regional/local plans to meet core and regional/local regulatory requirements Review risk minimization materials to optimize impact to key risks and RMiP goals 27

28 RMC Core responsibilities: Project Execution and Close-out Monitor and control implementation of RMiPs and complex PE Studies Maintain project management plan Distribute project performance metrics RMiP Operational plan Perform integrated change control Provide guidance on revisions of core or regional/local RMiPs based on assessments of effectiveness Close projects and update organizational process assets Project Management Plan Historical Information Tools/Templates, RMC Wiki 28

29 The Risk Management Coordinator Model The structure supports risk minimization holistically Quality system Governance/ advisory structure Processes Support/resourcing Organizational knowledge Effectiveness of the model depends on Communication Reinforcement of roles and responsibilities Collaboration Ability to adapt to different geographies Developing expertise in risk minimization regulations, activities, and assessments Implementing best practices across programs Managing capacity and prioritization of RMiP and pharmacoepidemiology studies 29

30 FoREMS & More Occurs the second Wednesday of every month 12:00 pm ET Next session: Wednesday, October 9, ParagonRx International LLC

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