Program Overview
Regulatory non-compliance in the pharmaceutical industry carries not only reputational damage but also significant financial consequences — from sanctions and product recalls to market disruptions and legal liabilities. This program helps finance, compliance, and strategy professionals evaluate how regulatory risks affect capital allocation, profitability, and enterprise value. Through real-world case studies like Johnson & Johnson, Merck, and Roche, participants learn to integrate risk-adjusted financial modeling, sensitivity analysis, and contingency planning into investment decisions. The course bridges the gap between operational compliance and financial accountability, equipping leaders to build resilient capital strategies that anticipate and absorb regulatory shocks effectively.
Features
- Assess the financial impact of regulatory sanctions and product recalls using advanced investment models
- Integrate risk management strategies into capital budgeting and investment planning
- Develop financial provisions and contingency strategies to mitigate the effects of regulatory and recall risks
- Design interactive dashboards to monitor and report on compliance risks and financial exposure in real time
Target audiences
- Finance & Risk Leaders
- Compliance & Regulatory Affair Professionals
- Operations & Supply Chain Leaders
- Strategy Teams
Curriculum
- 6 Sections
- 38 Lessons
- 1 Day
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- Understanding the Financial Impacts of Regulatory Sanctions6
- 1.1Regulatory sanctions and their impact on revenue streams
- 1.2Cost of compliance failures: fines, litigation, and business disruption
- 1.3Market withdrawal costs and the opportunity cost of regulatory delays
- 1.4Reputational damage and long-term financial consequences
- 1.5Regulatory risk vs. business risk in pharma
- 1.6Quick diagnostic – Assess organization’s exposure to regulatory risks and outline the potential financial consequences of non-compliance
- Product Recalls and Their Financial Ramifications8
- 2.1Direct and indirect costs of product recalls
- 2.2Regulatory triggers for recalls — FDA, EMA, WHO guidelines
- 2.3The supply chain impact of product recalls: recall logistics, reverse supply chain costs
- 2.4Loss of sales, market share erosion, and stock price fluctuations
- 2.5Legal liabilities and product liability insurance
- 2.6Financial provisions and contingency planning for recalls
- 2.7Case Example: Johnson & Johnson — Tylenol recall case and its long-term financial impacts
- 2.8Simulate a product recall scenario – calculate direct and indirect costs, reputational damage, and lost revenue
- Risk Analysis in Pharma Investment Decisions8
- 3.1Risk-adjusted return analysis for pharma investments
- 3.2The role of compliance risk in capital budgeting and investment forecasting
- 3.3Applying sensitivity analysis and Monte Carlo simulations to assess investment risks in the context of regulatory uncertainty
- 3.4Estimating potential liabilities and creating contingency reserves for regulatory-related risks
- 3.5Probability-weighted NPV and its application to uncertain environments (clinical trials, new product launches)
- 3.6Case Study: Roche’s capital budgeting decisions under regulatory pressure for oncology drugs
- 3.7Case Study: Sanofi’s response to EU and US compliance risks in vaccine development
- 3.8Exercise: Develop a risk-adjusted capital budget for a pharma product portfolio, incorporating regulatory risk and potential product recall scenarios
- Financial Provisions for Regulatory Non-Compliance7
- 4.1Setting up reserve funds for recall-related costs and regulatory fines
- 4.2Financial and operational governance in compliance-related provisions
- 4.3Contingency funding for dealing with regulatory investigations, sanctions, and litigation
- 4.4Financial reporting of potential liabilities under IFRS and GAAP
- 4.5Role of insurance in mitigating risks from product recalls and regulatory fines
- 4.6Case Study: Merck’s legal and financial provisions after regulatory sanctions on manufacturing
- 4.7Exercise: Create a contingency fund model for a hypothetical recall scenario, including legal, logistical, and reputational costs
- Regulatory Compliance & Operational Risk5
- 5.1Designing an operational risk dashboard for tracking regulatory compliance
- 5.2Integrating real-time data (supply chain, production, and regulatory updates) into risk management strategies
- 5.3Tracking risk KPIs — regulatory filings, audit results, non-compliance events, and recall incidences
- 5.4Proactive risk management strategies for compliance teams and executive leadership
- 5.5Exercise: Build an interactive regulatory compliance risk dashboard – integrating real-time data feeds and regulatory alerts
- Action Planning & Risk Management Roadmap4
- 6.1Regulatory Risk Management Activity: Define 3 actionable initiatives for better managing regulatory compliance risks and financial provisions in their business
- 6.2Risk mitigation strategies and action points
- 6.3Improved financial reporting and provision strategies
- 6.4Key compliance risk metrics and ongoing tracking systems
Instructor
