This course is designed to serve biopharmaceutical industry participants who wish to gain a comprehensive understanding of patient registry programs. Topics are introduced at the basic level but rapidly progress to cover more advanced, in-depth, and complex issues in program development and implementation. The seminar provides tools for participants involved in registry planning and design as well as for participants involved in registry project management and operations.
- Determine whether a registry is the right type of study, given your product profile, timeline, budget, and other study options
- Design a registry to meet both your research and your commercial objectives
- Implement a registry study, and how registry study conduct must differ from phase IIIB-IV clinical programs in order to succeed
- Solve problems that arise during the course of a registry program, and how to make mid-stream corrections and improvements without derailing the project
- Drive enthusiasm for your program and your product, while maintaining high ethical and research standards
- Clinical, Marketing, and Medical Affairs personnel
- Staff from pharmaceutical, biotechnology, medical device, or contract research companies involved with the development or implementation of registries
- Research leaders seeking to learn how a well-designed registry study can serve their research agenda
- Product teams considering a registry alongside or in lieu of a phase IIIB or phase IV clinical trial
- Clinical trial personnel desiring greater familiarity and comfort with observational designs
- Project team leaders who are or will be managing a registry program
- CRO personnel wishing to initiate or improve their delivery of registry program services
David Stier, M.D.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Introduction to Registries: What differentiates registries from other clinical programs; evolution of registries from academic centers to industry context; overview of registry design and implementation
- Creating the Research Plan: Primer of observational epidemiology; which research questions can/cannot be answered using observational designs; hypothesis generation and testing; approach to data analysis; maximizing research output
- Creating the Commercial Plan: Using registries to build or strengthen the customer base, communicate product messages, drive product utilization; strategy vis-à-vis competing products; strategic use of sales force
- Registry Technical Design: Getting the most from an advisory panel; subtleties of protocol-writing; determining site and subject criteria; selecting data instruments; prospective vs. retrospective data collection; defining and incorporating clinical, economic, and patient-reported endpoints; regulatory issues; risk management
Day 2: 8:30 a.m. – 5:00 p.m.
- Study Conduct: Registry project management; site training options; streamlining investigator recruitment materials; working successfully with community investigators; cost-effective methods of monitoring and maintaining data quality; practical decision-making with respect to GCP adherence; web-based vs. paper-based methods of data collection
- Providing Value to Investigators: Creating meaningful benchmark reports; using registries for clinical quality improvement efforts; setting investigator fees; data use agreements
- Understanding Costs and Benefits: Estimating and managing program cost; calculating return on investment; strengths and limitations of outsourcing; making in-house programs succeed without a CRO
- Putting it all Together: Interactive exercises using simulation, enabling participants to consolidate their understanding of the course material in the development and critique of mock registry programs
- Registry development simulation based on mock case-study scenarios
- Seminar participants are encouraged to bring their current program challenges for discussion and problem-solving
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-14-008-L01-P. Released: 5/14.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.