UPCOMING

Scaling Legal Readiness for High-Stakes Product Issues in Highly Regulated Industries

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12 Nov, 2026 | 
12:00 PM EDT
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60 mins
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Speakers

Ellen Salamone
Ellen Salamone
Head of Life Sciences and Healthcare
Axiom
Kristen McCaughan
Kristen McCaughan
Senior Vice President
Reservoir Communications Group

A quality concern, safety signal, or supply disruption can put life sciences teams under pressure fast. They may need to assess potential patient impact, determine reporting obligations, coordinate with quality and regulatory affairs, and respond to questions from providers, customers, regulators, employees, investors, and the media. Those decisions often have to be made while the facts are still coming into focus.

For in-house legal teams, the challenge is managing urgent, interconnected work without losing sight of the decisions that matter most. Clear escalation paths, close coordination across the business, and enough capacity to handle the surge can help teams respond with greater clarity and control.

Join Axiom and Reservoir Communications Group for a practical discussion on preparing for high-stakes product issues in highly regulated industries. The speakers will explore scenarios such as recalls, field actions, safety matters, and manufacturing or supply disruptions, with life sciences examples, including FDA-related considerations. They will discuss how legal, regulatory, quality, operations, and communications teams can coordinate their response, and how the lessons apply across other regulated sectors.

What you’ll learn

  • How to clarify decision-making, escalation paths, and responsibilities during a fast-moving product issue
  • Which legal and regulatory workstreams may demand attention in the first hours and days
  • How to coordinate legal, regulatory, quality, safety, operations, and communications teams as facts develop
  • How to align stakeholder communications with regulatory obligations and operational realities
  • Where flexible legal capacity can help teams manage a surge in work while core staff focus on critical decisions
  • What to include in a cross-functional readiness plan before an issue arises

Who should attend

This session is designed for general counsel and in-house legal leaders, as well as professionals in regulatory affairs, quality, compliance, product safety, communications, public affairs, reputation management, and legal operations. It will be especially relevant to teams responsible for product incident response in life sciences and other highly regulated industries.

Speakers

Ellen Salamone
Head of Life Sciences and Healthcare, Axiom

Kristen McCaughan
Senior Vice President, Reservoir Communications Group

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Register to learn how legal, regulatory, quality, and communications teams can coordinate a clearer, faster response when a product issue puts patient trust and business operations at stake.

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What you’ll learn

  • How to clarify decision-making, escalation paths, and responsibilities during a fast-moving product issue
  • Which legal and regulatory workstreams may demand attention in the first hours and days
  • How to coordinate legal, regulatory, quality, safety, operations, and communications teams as facts develop
  • How to align stakeholder communications with regulatory obligations and operational realities
  • Where flexible legal capacity can help teams manage a surge in work while core staff focus on critical decisions
  • What to include in a cross-functional readiness plan before an issue arises

Who should attend

This session is designed for general counsel and in-house legal leaders, as well as professionals in regulatory affairs, quality, compliance, product safety, communications, public affairs, reputation management, and legal operations. It will be especially relevant to teams responsible for product incident response in life sciences and other highly regulated industries.

Speakers

Ellen Salamone
Head of Life Sciences and Healthcare, Axiom

Kristen McCaughan
Senior Vice President, Reservoir Communications Group