Pharmaceutical Executive Europe - November/December 2007 - (Page 34) 34 Risk management Nov/Dec 2007 Pharmaceutical Executive Europe begins in the earliest stages of product development can reduce risks for both patients and bio/pharmaceutical companies. Like any prudent investor, pharmaceutical companies need in-depth information about the relative risks of their potential products before they make strategic development decisions, in order that they create a portfolio that balances risk and safety appropriately. By investing in this broader-based pharmacovigilance approach, a company will have the data it needs to make earlier, and better informed, go/no-go decisions that could decrease Phase III trial failures and product withdrawals. The investments needed to implement these proactive safety objectives can be divided into four major categories: people, governance, processes, and technology. The benchmarks for investment in each category include: People ● Ensuring that the right people with the right skills are assigned to key safety functions; ● Creating comprehensive staff training programmes on safety requirements and processes; ● Establishing systems for proactive review, detection, and analysis of safety trends and signals, rather than reacting after a crisis occurs; ● Delivering consistent communications to all employees that reiterate their stake in pharmacovigilance and reinforce the roles they are expected to play in upholding the company’s safety values; and, ● Providing open channels for unbiased discussions of safety issues, and removing organisational ‘silos’ that impede information exchange and co-operation. Governance ● Defining and documenting safety positions and principles that align with corporate business objectives; ● Creating risk profiles and risk management plans for all products in development; ● Instituting centralised accountability and clear reporting responsibilities for safety; and, ● Implementing safety metrics that are relevant and functional. Processes ● Defining and documenting critical safety procedures; ● Integrating safety processes throughout the development cycle; ● Establishing strong due diligence and quality management procedures; ● Strengthening audit and inspection readiness programmes; and, ● Writing streamlined, reader-friendly safety procedures aligned with regulatory requirements and company policy. Technology ● Implementing process-driven, integrated technology platforms that support data sharing, provide real-time information, and facilitate data reconciliation; ● Ensuring effective technical support for quality management, knowledge management, training delivery, SOP deployment, and other safety processes; and ● Maintaining a flexible and robust safety database that supports the effective collection, analysis and reporting of key performance metrics. Proactive pharmacovigilance The challenge for the bio/pharmaceutical industry is to expand the current pharmacovigilance paradigm by improving safety performance and reducing risk without stifling innovation or severely limiting return on investment. The goal is not to eliminate risk, but to understand and manage risk across the product portfolio to create a strategic balance that enhances safety while also bringing innovative products to market more quickly. Like any prudent investor, pharmaceutical companies need in-depth information about the relative risks of their potential products before they make strategic development decisions. The first important step in implementing this approach is establishing safety and risk management as corporate values — creating a company-wide, proactive ‘safety culture’ that is integrated into every decision and every part of the company. Other key actions needed to establish a proactive safety culture include: ● Embracing safety and risk management as top corporate priorities backed by the full resources of the company and the support of executive management; ● Building a strong drug safety foundation into the earliest stages of drug development, and carrying it through the entire product life cycle; ● Establishing clear goals and metrics for improving safety performance and holding all levels of management accountable for accomplishing those goals; ● Combining the full range of safety functions under the pharmacovigilance ‘umbrella,’ including pre-trial considerations, clinical trial safety, risk management planning and strategy, postmarketing surveillance and reporting, and signal detection; and, ● Making effective decisions about in-sourcing or outsourcing of safety functions based on expertise, resources, and business goals.
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