### Definitions for Impact, Consultation, and Awareness in Regulatory Intelligence #### **1. Impact (High-Risk Insights)** Impactful insights are those with **immediate or significant implications** for GSK's regulatory compliance, market access, or product lifecycle. These insights require urgent action or changes to processes, policies, or strategies due to their potential to: - **Directly affect patient safety** or public health. - Lead to **non-compliance** with critical regulatory standards. - Result in **financial, reputational, or legal penalties**. - Trigger **supply chain disruptions** or product recalls. **Characteristics of Impactful Insights:** - High **urgency** and **priority** for decision-making. - Minimal need for validation or consultation; the evidence and risk are clear. - **Examples:** Changes in regulatory standards affecting product approval, urgent safety communications from regulatory authorities, or enforcement actions. --- #### **2. Consultation (Medium-Level Insights)** Insights requiring consultation are those that **pose a potential risk or opportunity** but lack sufficient clarity, data, or context to enable direct action. These insights demand collaboration with domain experts or cross-functional teams to assess their significance and develop an appropriate response. **Characteristics of Consultation Insights:** - **Moderate level of risk or opportunity**; impacts are not immediate but could escalate. - Require **validation**, deeper analysis, or alignment across teams. - **Examples:** Regulatory trends, proposed policy changes, or emerging technologies that could impact GSK's operations if adopted. **Key Stakeholders for Consultation:** - Regulatory affairs, compliance teams, legal experts, and product development teams. --- #### **3. Awareness (Low-Level Insights)** Awareness insights are those **informative in nature**, providing updates or context without requiring immediate action. These insights are used to **build knowledge** across the organization, ensuring teams are informed of evolving regulations, industry trends, and potential future challenges. **Characteristics of Awareness Insights:** - Low or no direct risk; mainly informational. - Serve as a foundation for **long-term planning** or **strategic foresight**. - **Examples:** General updates from regulatory authorities, industry best practices, or news about competitors' regulatory strategies. **Purpose of Awareness Insights:** - Enable GSK to **stay ahead of the curve** and prepare for potential risks or opportunities. - Foster a culture of **proactive compliance** and strategic adaptability. --- ### Comparison Framework | **Category** | **Risk Level** | **Action Required** | **Examples** | |--------------------|----------------|----------------------------------------|-----------------------------------------------------------------------------| | **impact** | High | Immediate action; directly implement changes. | Product recalls, critical safety updates, regulatory non-compliance risks. | | **consultation** | Medium | Expert analysis and collaborative decision-making. | Proposed regulatory changes, emerging trends, or ambiguous guidance. | | **awareness** | Low | Monitor and inform; no immediate action needed. | Informational updates, general regulatory trends, or competitor insights. |