SEARCH

UPCOMING LIVE SEMINARS
 






FDA's Human Subject Protection (HSP) Bioresearch Monitoring (BIMO) Initiative September 2010

Sep 30, 2010
Order the DVD of this seminar

Course Description 

In response to public concern, and federal inquiry, stemming from myriad current events involving the oversight of the products it regulates, the FDA has recently developed and issued new regulations, guidance, and procedures to support the agency’s mission to improve the conduct of clinical trials, assess the accuracy and reliability of clinical trial data, and secure the protection of human research participants involved in those trials. This course will address some of the incidents that have led to these new developments, the federal agencies involved in overseeing the FDA, their findings, and how the FDA’s response to the recommendations will impact the conduct of clinical trials.

VideoPreview 

 

Learning Objectives 

  • Describe causal factors and their relation to the current clinical research environment
  • Examine key areas of concern from Congress, the Office of the Inspector General (OIG), and the General Accounting Office (GAO)
  • Identify new regulations, guidance, procedures, coalitions, and working groups, and pending and proposed legislation

Who Should Attend 

  • Clinical Quality Assurance Professionals
  • Clinical Research Associates
  • Project Managers
  • Clinical Investigators
  • Study Coordinators
  • IRB Professionals
  • Institutional Officials involved in oversight of clinical research
  • GCP -Focused Regulatory Affairs Professionals 

Instructor 

Elizabeth Ronk Nelson, MPH

 

Click here for complete trainer biographies 

Course Length Time 

2 hours; 1:00 - 3:00 p.m. Eastern

Course Dates 

September 30, 2010

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

FOLLOW US ON: 

LinkedIn twitter Facebook 


On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
For details on our scenario-based practical GCP application on-demand course, click here.


GCP for Investigators
 

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

For more details on this scenario-based eGCP program for investigators please click here. 


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

Jan - July 2014 Edition

Winter CatalogDownload Today!  

Blended Curriculum Path for the CRA, CRC, and Project Manager

BCP Cover

Download Today! 

 

 

 


 

DVD IconWEB SEMINAR ARCHIVE 

 View Catalog of Offerings   

New Titles added every month! 
Course Alumni Save 50% 


Live SeminarLIVE SEMINARS

Monitoring Clinical Drug Studies: Intermediate 

Informed Consent Content & Process Requirements for Biobanking Studies 

Auditing Techniques for Clinical Research Professionals 


Web SeminarWEB SEMINARS

10-Week CRA & CRC Beginner Program  

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance 

Use of Notes to File in Clinical Trial Essential Documentation 

10-Week Clinical Research Associate (CRA) On-Boarding Program  


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)