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SARA Codex

SARA Codex

Society for AI in Regulatory Affairs

Version 1.0

Purpose

Artificial Intelligence is reshaping Regulatory Affairs at an unprecedented pace. While the opportunities are significant, the profession also faces new challenges relating to governance, transparency, accountability and trust.

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The Society for AI in Regulatory Affairs (SARA) exists to provide an independent, international platform where regulatory professionals, quality professionals, academia, technology providers, industry leaders and former regulatory authorities can explore, discuss and advance the responsible use of Artificial Intelligence within Regulatory Affairs.

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The SARA CODEX defines the principles, values and governance that guide every activity undertaken under the SARA initiative.

Intended Purpose

The intended purpose of SARA is to improve the understanding, governance and responsible implementation of Artificial Intelligence within Regulatory Affairs across the global Life Science industry.

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SARA fulfils this purpose by facilitating education, knowledge sharing, collaboration and evidence-based discussion that helps organisations make better regulatory decisions.

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SARA promotes practical implementation, critical thinking and continuous learning while recognising both the opportunities and the limitations of Artificial Intelligence.

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SARA exists to strengthen the Regulatory Affairs profession—not to promote any particular technology, organisation or commercial interest.

Scope

SARA may organise or facilitate:

  • Educational webinars

  • Conferences and seminars

  • Expert roundtable discussions

  • White papers

  • Research publications

  • Industry surveys

  • Interviews

  • Best practice guidance

  • Educational resources

  • Advisory initiatives

  • International collaborations

  • Community forums

  • Professional networking

Out of Scope

SARA does not:

  • Provide legal or regulatory advice.

  • Replace regulatory authorities, notified bodies or recognised standards organisations.

  • Lobby on behalf of commercial interests.

  • Promote AI adoption without considering associated risks.

  • Present unsupported claims or misleading information.

  • Operate as a sales or marketing channel for commercial products or services.

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Commercial products and services may be referenced where they contribute educational value, illustrate practical implementation or support informed discussion. Such references shall always be transparent and proportionate.

Core Principles

1. Regulatory First

Regulatory objectives, patient safety, product safety and public trust always take precedence over technological innovation.

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Technology should strengthen Regulatory Affairs, not redefine its purpose.

2. Evidence Before Opinion

SARA encourages discussions grounded in evidence, practical experience and transparent reasoning. Opinions are valuable when clearly presented as opinions.

3. Balanced by Design

Every meaningful discussion should consider:

  • Opportunities

  • Risks

  • Limitations

  • Uncertainties

  • Governance implications

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SARA neither promotes nor discourages Artificial Intelligence. SARA promotes informed decision-making.

4. Human Accountability

Artificial Intelligence supports regulatory professionals.

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Responsibility for regulatory decisions always remains with qualified people.

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Professional judgement cannot be delegated to software.

5. Transparency

Participants should openly disclose relevant commercial interests, use of AI where materially relevant, assumptions, limitations and potential conflicts of interest.

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Transparency creates trust.

6. Practical Relevance

SARA prioritises practical implementation over theoretical discussion.

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Every activity should provide knowledge that participants can apply within their own organisations.

8. Constructive Challenge

Professional disagreement is welcomed.

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Questions, alternative viewpoints and critical discussion are encouraged when conducted respectfully and supported by reasoned argument.

9. Continuous Learning

Artificial Intelligence, regulation and professional practice continue to evolve.

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SARA embraces continuous learning, continuous improvement and intellectual curiosity.

7. Global Perspective

Regulatory Affairs is international.

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SARA seeks contributions from different markets, regulatory systems, organisation sizes and professional backgrounds to promote broader understanding and collaboration.

Education and Commercial Activities

SARA recognises that education, consulting, software, professional services and training are essential components in advancing responsible Artificial Intelligence within Regulatory Affairs.

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Founding Members, Strategic Partners, Community Members and other participating organisations may develop and offer commercial products and services that contribute to the mission of SARA.

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Such activities are encouraged provided they:

  • support the Intended Purpose of SARA;

  • comply with the principles defined in the SARA CODEX;

  • are presented transparently and ethically;

  • clearly distinguish educational content from commercial offerings; and

  • strengthen trust within the Regulatory Affairs community.

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Commercial activities conducted outside official SARA activities remain the responsibility of the respective organisation.

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Participation in SARA does not constitute endorsement, certification or exclusivity.

SARA Aligned

Organisations may describe educational programmes, workshops, consulting services, methodologies, software implementations or other professional activities as SARA Aligned when they demonstrably follow the principles of the SARA CODEX and contribute to the Intended Purpose of SARA.

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The designation SARA Aligned represents a public commitment to responsible, transparent and evidence-based practice.

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It is not a certification, accreditation or regulatory approval.

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SARA founding members reserves the right to define, maintain and revise the criteria governing the use of the SARA Aligned designation.

Quality Principles

SARA strives to ensure that every activity is:

  • Independent

  • Transparent

  • Evidence-informed

  • Practical

  • International

  • Balanced

  • Respectful

  • Professionally relevant

Decision Framework

Before initiating any activity, SARA asks:

  • Does this support the Intended Purpose of SARA?

  • Does it provide educational or professional value?

  • Is it balanced and evidence-informed?

  • Is it transparent regarding commercial interests?

  • Does it strengthen trust within the Regulatory Affairs profession?

  • Does it contribute positively to the responsible adoption and governance of AI?

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If these questions cannot be answered positively, the activity should be reconsidered.

Commitment

SARA is founded on the belief that Artificial Intelligence will fundamentally influence Regulatory Affairs.

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The quality of that future will depend not only on technological capability, but on governance, transparency, professional judgement and collaboration.

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By participating in SARA, individuals and organisations commit to advancing the profession through responsible dialogue, practical learning and evidence-based collaboration in accordance with the principles of this CODEX.

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