Sample Forum Abstract
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Abstract Title
Implementing Regulatory Outsourcing Partnerships: New Trends and Practices
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Track
Regulatory
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Keywords
CMC, CROs, Outsourcing, Preferred Providers, Quality Systems, Regulatory, Service
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Level
Intermediate
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Learning Objective(s)
Discuss examples of regulatory outsourcing partnerships and review regulatory partnership agreements for their respective benefits to their organizations; Describe best practices from a regulatory outsourcing survey.
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Overview
This forum will present examples of regulatory outsourcing partnerships and discuss trends in this area. A panel of experts will provide their interpretation of data from results of a global regulatory outsourcing survey and share best practices.
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Abstract Details
It is well recognized that trends in outsourcing of clinical monitoring, data management, and central laboratory services have seen growth with outsourcing penetration rates above 50%. However, regulatory outsourcing has not yet reached such levels of outsource penetration but new learnings suggest such outsourcing is increasing. Barclays have reported that in 2011 only 18% of regulatory was outsourced. Data from a regulatory market survey will be provided to participants. Survey results will share various insights in outsourcing including which regulatory areas have higher rates of outsourcing penetration, top areas of concerns in outsourcing regulatory functions, and future trends.
Areas of regulatory focus will include:
- New Drug Submissions
- Clinical trial application
- Quality and Compliance Services
- Pharmacovigilance
- Regulatory operations (document publishing and eCTD)
Analysis and interpretation of survey data will be shared. This forum will also provide case histories of several successful working outsourcing partnerships. These will be presented by experts involved in successful regulatory partnerships. One case includes an innovative partnership in which an outsource provider supported postmarketing regulatory support of over 20 products across a variety of therapeutic categories. Outsource services provided included maintenance of INDs, NDAs, BLAs, periodic adverse drug experience reports, preparation of labeling supplements, critical issue management and acting as the designated representative to the FDA on behalf of the sponsor.
Presenters will share selection criteria used to select outsource provides along with processes and tools used to measure success. In addition, presenters will provide their commentary on the survey results relative to their experiences to compare and contrast those of their fellow industry colleagues.