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#31: Large-Scale Regulatory Functional Outsourcing: Emerging Trends, Challenges and Decision Criteria

Tutorial name:
#31: Large-Scale Regulatory Functional Outsourcing: Emerging Trends, Challenges and Decision Criteria

Day & Time:
June 15, 1:00PM - 4:30PM (Pacific Standard Time)

Room Number:

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Thirty years ago, the practice of outsourcing clinical trials was modest and fledgling. Today, as a result of a dramatic evolution of both strategic thinking and operational implementation, clinical outsourcing is well established and broadly accepted across the pharmaceutical industry and across the globe as a must-have component of clinical R&D.

Regulatory tasks have also been outsourced to consultants and CROs during this period of time, not on a grand scale but rather on a transactional project-by-project basis that required deep and substantial scientific and regulatory expertise. On the other hand, regulatory affairs departments have been reluctant to “let go” of large swaths of regulatory work. Variations, supplements, annual reports, and regulatory maintenance tasks have been deemed too sensitive, mission-critical, delicate, or onerous to give out to others. This sentiment is now colliding with economic pressures and the costs of the internal infrastructure required to perform these tasks year after year for scores of countries. Sponsors are reexamining their thinking, in some cases releasing very significant portions of regulatory work to service providers, in others beginning to assess the benefit/cost of keeping all tasks “in-house.” As this occurs, it is appropriate to assess the drivers of this change, to understand the opportunities and concerns associated with regulatory outsourcing on a large scale, and to examine the criteria which are or could be used to evaluate service providers prior to selecting them.

Learning Objective(s):
At the conclusion of this tutorial, participants should be able to:
• Identify the new trends in RA outsourcing and product life cycle management;
• Discuss the opportunities to reduce internal regulatory infrastructure fixed costs while achieving regulatory milestones;
• Identify the concerns of sponsors when considering significant regulatory outsourcing;
• Describe the criteria used by sponsors to select/reject RA outsourcing service providers.

Target Audience:
This tutorial is designed for those working in regulatory affairs, outsourcing and drug life cycle management.