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Did you just say Safety Governance Model?

Posted on May 27th, 2016 by in Pharmacovigilance


We usually tend to think that our overall compliance to regulations and fulfilling our ethical commitment to patient safety is best answered through an established set of Policies and SOPs. We design processes around regulatory mandates and adjust to the complexity of the enterprise as much as we can, feeling confident that all our bases are covered.

But this might be true only to some extent. This process-focused approach may prevent us from having a systemic and strategic review of the validity of all the processes and decisions regarding any safety data (in its broadest definition) generated in any part of the enterprise. It may also keep us from looking critically at how we assess the impact of this data on patient safety.

A system-wide and dynamic approach is better for ensuring that all the company’s safety (again, in its broadest definition) related activities are organized under a logical, efficient and comprehensive Safety Governance Model (SGM) across the enterprise. A holistic framework for governance will best translate the enterprise-wide commitment to patient safety into committees, roles, responsibilities and processes throughout the organization.

Some critical principles are needed for its successful implementation[i]. Such a model should be:

  1. Cross-functional: all functions and employees are responsible for safety;
  2. Across the extended enterprise: extended to partners, suppliers, affiliates and distributors;
  3. Leadership-driven: the governance model is led by senior leadership;
  4. Periodic and predictable: the committees and processes are executed on a periodic basis as clearly defined in the corresponding charters and SOPs;
  5. Inclusive of people, process and technology: the model is supported by a total alignment of organizational structure, safety-related processes and tools, and technology to support patient safety.

It will serve the strategic objectives of:

  • Ensuring a culture of quality and compliance through policies, oversight, education and remedial actions;
  • Ensuring that appropriate ethical, medical, scientific, safety and regulatory standards are established and met through policies, processes, monitoring, auditing and enforcement;
  • Providing senior leadership oversight of all issues related to patient safety and ongoing activities.

Where do you fit in this? Here are some questions which can help you assess if your company has a robust Safety Governance Model in place:

  • What is the level of understanding of the roles and responsibilities of the different committees and councils which handle safety related information (such as safety, labeling, quality, clinical development, complaints review, product recall, etc.)?
  • What is the clarity and accessibility of the charters defining the scope of responsibilities of these different committees?
  • How much are you prepared for a crisis situation (e.g., recall, urgent notification, safety alert)?
  • Is there a clear, organized escalation process to the top of the organization for urgent and critical safety issues?
  • What are the different levels for reviewing safety data, deciding and approving on safety actions? Do you have a well-defined multi-tiered framework in place to analyze, aggregate, recommend and approve actions regarding safety matters?
  • Are there functional areas where PV is not represented as it should be?
  • What is the level of understanding and support of safety across the organization and at the executive level?

If you are uncertain about the responses to some of the above questions, the possibility that you will face significant challenges in the near future is probably higher than it should be, and it is certainly wise to engage in significant revision of the safety framework in place. The concept of SGM is, by the way, an extremely powerful way to convey a critical message for change at the enterprise level. We will suggest some recommendations on how to create awareness and initiate change in future postings.


[i] DIA Pharmacovigilance and Risk Management Strategies, Tutorial on Principles and Practices of Pharmacovigilance Governance, January 24, 2016

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