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| ### 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. | | |