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Critical Decision Points in the Design & Conduct of Patient Registries June 2010

Course Description

Patient registries are based on principles of observational research and offer remarkable flexibility in design and applications. They have demonstrated value in both the biopharmaceutical and the medical device arenas. Patient registries are appealing to physician investigators, and can serve as a centerpiece or as an adjunct to a product’s late-phase scientific and promotional strategy.

Although registries share some features with clinical development trials, they diverge in many important respects. Clinical, risk management, and product marketing teams can collaborate successfully to develop and implement patient registry programs. All team members should have a clear understanding of the design elements, the operational issues, and the strengths and limitations of registries.

This Interactive Web Seminar will focus on the most critical issues in the design and conduct of patient registries for biopharmaceutical and medical device applications. The seminar will cover the questions most frequently raised by clinical, risk management, and product marketing teams engaged in the development and implementation of registries.

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Learning Objectives

  • Discuss all the basic components of a successful registry program
  • Examine when patient consent and IRB/Privacy Board approval is required
  • Design benchmark reports that physicians will actually want to read
  • Turn community physicians into comfortable, productive registry site investigators
  • Choose study endpoints: Walking the tightrope between what is desirable and what is realistic

Who Should Attend

  • Clinical Programs/Trials
  • Clinical Research
  • Clinical Affairs
  • Medical Affairs
  • Regulatory Affairs
  • Project Management
  • Patient Registries
  • Market and Business Development

Instructor

David Stier, MD

Click here for complete trainer biographies

Course Length Time

1.5 hours; 12:30 - 2:00 p.m. Eastern

Course Dates

June 24, 2010

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471

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PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)