Assessment of Your In-House, Outsource or Off-Shore Safety Infrastructure

Companies with established safety organizations can benefit from the extensive experience of Wendy Stephenson & Associates (WSA). The nature and scope of the effort will be carefully defined and agreed with the client, ranging from a full top-to-bottom evaluation of the organization’s structure and function to a limited evaluation of a specific aspect, taking the form of a strategic assessment or a more formal regulatory compliance audit. We have experience with both approaches and will adapt the focus and form to your specific needs and preferences.

WSA will provide advice on global organizational and operational aspects of drug safety and related functions (e.g., labeling, epidemiology). Such advice includes:

• Assessment of the current structure and operations of company drug safety department(s) with recommendations on how to optimize functioning and enhance interaction with other departments (headquarters and affiliates) and external business partners
• Assessment of standard operating procedures, training and safety database systems with recommendations to enhance the company’s ability to handle safety information and meet current /anticipated regulations
• Analysis of the current performance of drug safety responsibilities in company operating units with respect to current and anticipated international drug safety reporting requirements
• Review of existing decision-making structure with recommendations to optimize the company’s ability to make swift and effective decisions that affect safety, both during development and post-approval.
  

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