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June 3-4, 2013
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Biosimilar Products: Understanding FDA Requirements
June 4-5, 2013
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Phase I Study Management

Upcoming Courses
Course #: BI11375
October 11, 2013
1:00 PM - 2:30 PM Eastern
$595.00

Course Description

Because the early life of a compound is dependent on the data and analysis derived from Phase I Studies, it is imperative that these trials are managed and conducted with the highest quality and care. Therefore, well-honed project management skills that can address the unique issues associated with Phase I Studies are needed. This web seminar will examine the importance of Phase I Studies in drug development, the issues commonly associated with conducting a Phase I Study from a sponsor perspective and provide project management best practices specific to overseeing a Phase I Study.

Learning Objectives

  • Define Phase I Studies
  • Examine the importance of Phase I data in clinical development
  • Review general considerations for a Phase I Study
  • Describe the attributes of an effective Phase I Unit
  • List project management best practices specific for Phase I clinical trials

Who Should Attend

  • Project Managers
  • Study Directors
  • Site Monitors

Instructor

Erica Elefant, R.N., B.S.N., M.S.W.

Click here for complete trainer biographies 

Registration Fees

$595

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 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#: 778-000-09-061-L04-P. Released: 6/10. 

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471. 

 

 

 

On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
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Barnett 'Hands-On' In-Person and Web Seminar Workshop Series
Barnett "Hands-On" Workshops are designed to provide intensive, hands-on training in a highly targeted clinical research topic area in a very interactive and engaging learning environment. To view more details and available courses, click here.


BARNETT CATALOGThe Barnett Catalogue is your comprehensive guide to the myriad live, web, and custom training opportunities offered throughout the year. 

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Web SeminarWEB SEMINARS

10-Week CRA & CRC Beginner Program  

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Use of Notes to File in Clinical Trial Essential Documentation 

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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)