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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.
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#### **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.
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#### **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.
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### 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. |
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