Pharma R&D Structures, Activities & Responsibilities: Benchmark Interviews

R&D Quality organizations face universal challenges such as navigating global regulatory and cultural differences, correcting staffing shortfalls and communicating the importance of regulatory compliance within R&D. This 11-page document summarizes the insights and best practices of leading pharmaceutical executives from nine top companies. It outlines the activities and responsibilities of the R&D functions at their organizations. The research also contains metrics on auditing targets and a response matrix from partners that details trouble areas for staffing.

Sample Best Practices

1. Develop forums that allow for cross-functional discussion of quality issues to manage the complexity inherent in R&D quality efforts.
   *One benchmark partner has a quality council that includes chemical and pharmaceutical development representatives along with members of the R&D global compliance auditing group. The council meets monthly to discuss critical issues with the goal of reducing audit needs.
2. Ensure representation on product development teams to take a proactive stance toward R&D Quality.
   *One company has a relatively new initiative to create one quality assurance voice to provide input on each project. The team works to develop methods for products and typically includes five to six people, including someone from the GMP compliance group which represent the R&D quality organization on the team.
3. Develop consistent messaging throughout the organization about the importance of regulatory compliance within R&D.
   *Executives indicate that companies with world-class R&D quality organizations have found ways to instill a culture of quality throughout their customer base.
   

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