Agenda for Session Compliance in Clinical Research

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Presentation transcript:

Schering-Plough Corporation The Pharma, Biotech and Device Colloquium Applying a Risk-Based Compliance Model to Clinical Operations Michael Swiatocha Schering-Plough Corporation June 8, 2004

Agenda for Session Compliance in Clinical Research Risk Areas in Clinical Research Enterprise Wide Risk Management Model Case Examples Questions & Answers

Compliance in Clinical Research

Traditional Approach to Compliance in Clinical Research Focus on Quality Assurance Verify compliance with regulatory requirements FDA, EMEA, ICH GMPs, GCPs Pharmacovigilance Ensure the rights and safety of study subjects IRBs, Ethics Committees Informed consent Verify compliance with protocol requirements Site visits Ensure the integrity and quality of trial data Source data verification

Other Considerations for Compliance in Clinical Research Anti-Kickback Statute Investigator selection Fair market value for research funding Research grants and sales/marketing influences Medicare Billing for clinical trials False Claims Act and off-label promotion Patient recruitment incentives Privacy/HIPPA/EU Directive

Other Considerations for Compliance in Clinical Research OIG Compliance Program Guidance for Pharmaceutical Manufacturers Investigator Initiated Studies Sponsorship Documentation Commercial product as clinical supplies PhRMA Principles for the Conduct of Clinical Trials and Communication of Clinical Trial Results Publication plans New York State vs. GSK

Operational and Strategic Risks in Clinical Research Management of Product Portfolios and Lifecycles Batch Failures in Clinical Supply Production Health Outcomes and Reimbursement Support Protection of Intellectual Property Conflicts of Interest Product Liability Failures in Development Partnerships and Joint Ventures Problems with Service Providers (e.g., CROs, SMOs)

A New Strategy is Required Embrace the vision of compliance as a key business process Develop a systemic approach to meeting requirements Adopt an integrated view of risk management across all elements of the business

A Shift from a Compliance Focus to Risk Management Types of Risk Legal & Regulatory Operational Enterprise-wide Risk Management Approach Ethical Strategic

Enterprise-wide Risk Management Model

Enterprise-wide Risk Management Model Pharmaceutical & Medical Products Value Chain Infrastructure Support Research & Development Sales & Marketing Operations Human Resources, Finance, Legal Information Technology

Enterprise-wide Risk Management Model Three Major Phases Risk Identification Risk Assessment Risk Management

Enterprise-wide Risk Management Model Identification Develop Risk Profile Risk Assessment Risk Management

Enterprise-wide Risk Management Model Pharmaceutical & Medical Products Value Chain Infrastructure Support Research & Development Sales & Marketing Operations Human Resources, Finance, Legal Information Technology

Building a Risk Profile for the Company For Illustration Only

Building a Risk Profile for the Company Industry Risk Rating High – Major industry issue: high - potential impact, degree of focus, level of enforcement activity Medium – Moderate industry issue: moderate - potential impact, degree of focus, level of enforcement activity Low – Minor industry issue: no/little potential impact, no focus, no/little enforcement activity

Enterprise-wide Risk Management Model Identification Develop Risk Profile Develop Compliance Performance Scorecard Risk Assessment Risk Management

Building a Compliance Performance Scorecard Key Attributes Tested Adequacy of the compliance program controls in each risk category: Policies and Procedures Learning Management Monitoring Auditing Effectiveness of the Compliance Management Systems and Processes Efficiency of the compliance control environment and the burden of the compliance program on the business for each risk category Industry Risk Rating for each risk category

Building a Compliance Performance Scorecard For Illustration Only

Enterprise-wide Risk Management Model Identification Develop Risk Profile Develop Compliance Performance Scorecard Risk Assessment Risk Management Corrective Action Auditing and Monitoring

Enterprise-wide Risk Management Model Identification Develop Risk Profile Develop Compliance Performance Scorecard Risk Assessment Risk Management Corrective Action Auditing and Monitoring

Risk Management Process Enablers Instilling a culture of business integrity and ethical values Integrating EWRM into core business processes: QA Finance Strategic Planning Being proactive in identifying risks Measuring performance and calculating value

Case Examples

Examples of Risk Areas in Clinical Research Delegation of regulated responsibilities to service providers Field monitoring Recruitment of subjects Global trial management Regulatory agency inspection readiness Go/No Go Decisions in R&D New regulations (e.g., EU Clinical Trial Directive)

Questions & Answers

For More Information… Michael P. Swiatocha Vice President and SPRI Compliance Officer Schering-Plough Corporation 908-740-5260 michael.swiatocha@spcorp.com