Short Course* Registration: 7:30AM-12:00PM
Led by pharmaceutical industry regulatory operations staff, the course will take you through a journey to an optimized outsourcing model in Regulatory Operations and will cover outsourcing opportunities in both publishing and regulatory information management. Over the past 10 years outsourcing regulatory operations work has gone from marginal to an integral part of a successful organization. From simple contract outsourcing to strategic alliances, starting a new outsourcing project or further expanding an established one could be seen as a daunting project with multiple facets.
Through the course we will review case studies and industry experience on what a successful outsourcing project may look like, including transparency into what has worked well and potential hurdles.
*Short Courses are not included in the forum registration and require a separate fee.
Who should attend?
Professionals involved in:
- Regulatory Operations Publishing
- Regulatory Operations RIM
- Regulatory Operations Submission management
- Regulatory IS
At the conclusion of this short course, participants should be able to:
- Describe industry standards for determination of business need and subsequent requirements for sourcing (i.e. short term contracting, external service provider, etc.)
- Explain Mechanisms for determination of process maturity for outsourcing
- Discuss industry trends on scope of Regulatory Operations outsourced processes
- Describe decision criteria for outsourcing partner
- Outline baseline governance and communication processes
- Discuss the criticality of quality and performance metrics