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» Products & Services » » Quality, Compliance and Regulatory » Structure,Staffing and Execution

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

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ID: 4592


Features:

Graphics, Summary Matrix


Pages/Slides: 11


Published: Pre-2013


Delivery Format: Online PDF Document


 

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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Study Overview

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.
Methodology
This research orginates from a Best Practices, LLC consulting project. It is based on executive interviews with several leading pharmaceutical companies.

Industries Profiled:
Pharmaceutical; Biotech; Health Care; Medical Device; Diagnostic


Companies Profiled:
Sanofi-aventis; Lilly; Amgen; Johnson & Johnson; Abbott; Boehringer-Ingelheim; GlaxoSmithKline; Cardinal Health; Mayne; Medarex; Bristol-Myers Squibb


If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.