Developing a crisis management playbook designed for the challenges of the pharmaceutical industry sector is vital to ensuring long term business continuity. Below are a few critical risk management elements you should consider for your team during crisis handling & developing a crisis management playbook.
Risk Management
Being able to identify factors that impacted product safety or regulatory compliance is one of the most important elements during the risk assessment phase. During RCA’s risk management services process, operational risk management is one of the first remediation steps to consider.
Identify Risk
Being able to identify the product hazards that caused the crisis is critical to understand scenario planning. Conduct due diligence to ensure that your product design outputs include no risks that are unnecessary to the consumer. Hazards that do include one or more risk factors must be analyzed why the patient benefit exceeds the financial risk.
Measure Risk
During scenario planning, identify the critical elements to measure your team and results by via a risk management framework. A risk profile for each product in question can support evaluating, reporting and monitoring adverse events. Systemic risk should be analyzed for product risk profiles with longer term, reoccurring events or specific pharmacovigilance indicators identified as proactive crisis control.
Mitigate Risk
Being able to work clearly and concisely with your regulatory agency is critical for the due diligence solutions presented for review. Examining all hazards that have been identified during the risk mitigation phase is essential to success during the risk management process. Consider any of the threats that are regarded as acceptable with known risks and document unusual activity in your risk management plan.
Crisis Management Communications
An initial step recommended by RCA’s medical device consulting team is to identify and evaluate the regulatory compliance dangers and situations. For example, assessing the vulnerability of medical device cybersecurity must consider internal and external threat modeling. Any type of cyber breach that might impact your operations team, business reputation, or stakeholder relationships should have a detailed communication strategy.
Crisis Communication Plans
A veteran RCA medical device consultant suggests developing a universal shared space where team members can bookmark & access the crisis comms document. A communication strategy would then be shared with communication partners engaged in the public relations and crisis management campaign.
Risk Management Communications
Inside a successful crisis communication team, everyone knows their role and responsibilities. RCA’s regulatory consulting Experts often designate a process leader who clearly understands the team stakeholders and functions they represent. Refine your approval process so that messaging not only meets external approved communications from these stakeholders, but also legal concerns.
Crisis Control
A detailed risk management communication plan helps specify different examples for sharing risk messaging to either internal audiences or external stakeholders. Design your communication plan templates so that information is easy to understand for multiple audiences. Different types of tactics to be considered for templates (e.g. press release, social media) to confirm the messaging reliability of the crisis communication strategy.