assets/classification_system_message.md

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.