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Proactive communications around risk management is a new critical success factor for life-cycle management. Ilyssa Levins • The Center for Communication Compliance Everyone needs to be accountable for regulatory compliance, including communication agencies, which can no longer abdicate responsibility to clients. More comparative data and increased risk assessment before and postapproval are now more essential than ever. Products deemed to have serious risks can experience approval delays or even be removed from the market. Compliant Communication While promotional regulations differ by country, the implications of noncompliance are far-reaching, including billions of dollars in fines, personal indictments, and a spiraling distrust of the industry. Everyone needs to be accountable for regulatory compliance, including communication agencies, which can no longer abdicate responsibility to clients. Clients must require agencies to invest in independent training and certification apart from company-provided information. Tightened budgetary belts are no excuse for putting this off — the stakes are too high. Sales reps are trained and tested periodically to ensure their knowledge of government requirements and voluntary codes. Training and testing for communication professionals must follow suit. Cross-functional Communication Global executives must actively communicate across cross-functional teams to manage risk throughout all drug-development phases. Fully informed drug development cannot tolerate silos, which inhibit the ability of internal stakeholders to effectively define and act on critical points for risk management. Working hand in hand, companies will become more sensitive to the implications of early planning on drug approval/marketing (cause and effect), engage in more effective long-term planning for product development and approvals, and be able to agree on sustainable process improvement. Corporate Communication Corporations must effectively and proactively communicate risk information for any globally marketed product. Internal education on the details and the value of risk management programs helps ensure seamless implementation and execution. To anticipate and mitigate crisis situations resulting from announcements of adverse drug effects, internal preparedness planning must intensify. Externally, healthcare professionals, media, patients, and the public must understand the purpose and the need for risk communications to protect the reputation of global brands. An essential component of the postapproval communication plan is developing and putting in place strategies to frame a product’s risk/benefit ratio before launch as well as after launch. Cross-Cultural Communication Communicating risk information and implementing risk-management programs across diverse cultures is a daunting challenge for global corporations, wherever their home base may be. Cross-cultural awareness and planning are required to ensure consistent understanding of, and response to, risk information. This will occur only if communication professionals develop cultural competency so they can anticipate how risk messages might be filtered through diverse cultural perceptions and divergent criteria for evidence. The potential for misunderstanding and inappropriate response must be acknowledged and then proactively anticipated and prevented to the greatest degree possible. Creative Communication With the proliferation of new media channels, marketers will need to disseminate risk-management messages far beyond just a medication guide, patient package insert, or hospital and patient registry. More creative execution of educational materials and programs directed to physicians, hospitals, and patients will be required. F Global executives must actively communicate across teams.