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