ICH GCP E6 (R2) Training for Investigators and Site Personnel Webinar Seminar training classes conferences & workshops presented by Online Compliance Panel register for training on FindaSeminar.com

Home

Add your seminars

Training Calendar Creator Seminar Venues Training Provider Directory
 

New Seminar Search:  

 
find similar training...
Search by state...
Email this event ...

Customer Support


Do you need help finding the right class, date, or location or other assistance?

Request information about upcoming training seminars workshops and conferences in   and other cities listed on FindaSeminar.com Submit a support request and receive a prompt reply.

We guarantee this Online Compliance Panel training seminar

We are an authorized partner of Online Compliance Panel

 

Price protection. The price to attend ICH GCP E6 (R2) Training for Investigators and Site Personnel Webinar is set by the training providerThere is no added charge for our services.

We honor most training provider coupons
*.   Call  a representative to see if your discount coupon applies.


Privacy. Your personal information won't be shared with anyone but the training provider Online Compliance Panel.


Security. When you register for this seminar on FindaSeminar.com your personal data and payment information is safely collected and processed using secure SSL encryption technology.

Flexibility. FindaSeminar.com offers you three ways to register for ICH GCP E6 (R2) Training for Investigators and Site Personnel Webinar seminar by Online Compliance Panel.
Register online, by phone, or fax.
Who should attend ICH GCP E6 (R2) Training for Investigators and Site Personnel Webinar
Quality Assurance/Compliance Personnel, Principal Investigators/Sub-Investigators, Research Site Staff
Reviews
Write and read Online Compliance Panel reviews and reviews about the training seminar ICH GCP E6 (R2) Training for Investigators and Site Personnel Webinar on the Seminar News Network and the Training News Network.
 

Frequently asked questions and registration options for the training seminar ICH GCP E6 (R2) Training for Investigators and Site Personnel Webinar

 
Find Training Near You
Use our clickable map to find training near you
Use Our Clickmap
 
Education and training domain names

Education and training news articles

hotel seminars meeting space directory
hotel meeting space training facilities restaurant and lodging

 

ICH GCP E6 (R2) Training for Investigators and Site Personnel Webinar  

 Email information about this seminar ICH GCP E6 (R2) Training for Investigators and Site Personnel Webinar by Online Compliance Panel to yourself your manager or associates Email this event... View and register for other training seminars like ICH GCP E6 (R2) Training for Investigators and Site Personnel Webinar by Online Compliance Panel on FindaSeminar.com Find similar training.. Find and register for other training seminars by Online Compliance Panel on FindaSeminar.com Other seminars from Online Compliance Panel

By:

Online Compliance Panel   

For:

Quality Assurance/Compliance Personnel, Principal Investigators/Sub-Investigators, Research Site Staff

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

The revised Good Clinical Practice (GCP) guideline from the International Conference on Harmonization (ICH), known as ICH-GCP E6 (R2), has now been approved. This first update in two decades is expected to be adopted worldwide by regulatory agencies, including the FDA, EMA and Japanese Health Authority, and so brings major implications for all clinical development stakeholders.ICH-GCP E6 (R2) reflects the industry's growing emphasis on risk-based quality management, highlighting the increasing complexity of clinical trials and how the ongoing evolution in technology creates opportunity for greater efficiency in quality management. (see full course description)

 
 

 Seminar / Training class dates & locations

 
 SORT RESULTS BY:

 DATE

LOCATION

SELECTED VENUE DETAILS

Facility Name: 
Address:





Registration Information:

Event cost:  $
USD

class times and cancellation policy

 
 




 From 
 To 
 Click to register by Register by fax for ICH GCP E6 (R2) Training for Investigators and Site Personnel Webinar training seminar Register by mail for ICH GCP E6 (R2) Training for Investigators and Site Personnel Webinar training seminar Register by phone to attend ICH GCP E6 (R2) Training for Investigators and Site Personnel Webinar training seminar

Print payment approval request form ICH GCP E6 (R2) Training for Investigators and Site Personnel Webinar training seminar

Pre-Registration questions? Find answers in our registration FAQ or Request information about upcoming training seminars workshops and conferences in   and other cities listed on FindaSeminar.com Submit a support request

 
 
 

 

share this page 

print the agenda print agenda for the ICH GCP E6 (R2) Training for Investigators and Site Personnel Webinar seminar

 

 

Training Course Syllabus:


Objectives of the Presentation

Identify the changes impacting investigator responsibilities and roles
Explain the impact of the revisions to sites and Sponsors-Investigators
Evaluate solutions for applicability/modification of organizational SOPs, processes, procedures and staff training
Apply lessons learned for effective implementation of the new ICH GCP E6 R2 guideline

Why Should you Attend

The updated ICH GCP E6 R2 is more descriptive than the previous version and describes 26 items of change. These changes consist of new items in definitions; new sections on investigator responsibilities, including oversight; a substantial new sponsor section on quality management, including risk assessment; monitoring plans defined and implemented; introducing Risk-Based Quality Management; serious breaches, and, a new section on computer validation and electronic records, to name a few. This web seminar explores the changes in detail to promote a better understanding of how they impact clinical trials.

This course is not only a comprehensive guide to ICH-GCP but the implementation of GCP requirements is explained and illustrated using real life examples.

Areas Covered

What is ICH GCP?
Investigator Qualifications and agreements
Adequate resources
Medical care of trial subjects
Communication with IRB/IEC
Compliance with protocol
Investigational products, randomization procedures and unblinding
Informed consent of trial subjects
Source documentation and record keeping
Progress reporting/final reports
Safety reporting
Premature termination or suspension of trials

Who will Benefit

Quality Assurance/Compliance Personnel, Principal Investigators/Sub-Investigators, Research Site Staff (Managers, Clinical Research Coordinators, Data Managers/Data Entry)Managers/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management, Study Managers/Project Managers, Clinical Research Associates/Monitors (Centralized, On-site, Clinical Site Selection/Management Personnel, Clinical Site Coordinators (CRCs)Clinical Research Associates/Monitors (CRAs)Clinical Trial Managers (CTMs)Data Managers, Clinical Operations & Project Management, Compliance & Regulatory Affairs, study coordinators and research nurses, other hospital staff or ancillary staff involved in a clinical trial

Seminar Summary:

The revised Good Clinical Practice (GCP) guideline from the International Conference on Harmonization (ICH), known as ICH-GCP E6 (R2), has now been approved. This first update in two decades is expected to be adopted worldwide by regulatory agencies, including the FDA, EMA and Japanese Health Authority, and so brings major implications for all clinical development stakeholders.ICH-GCP E6 (R2) reflects the industry's growing emphasis on risk-based quality management, highlighting the increasing complexity of clinical trials and how the ongoing evolution in technology creates opportunity for greater efficiency in quality management. (see full course description)

print this agenda print agenda for the ICH GCP E6 (R2) Training for Investigators and Site Personnel Webinar training seminar

 view dates and locations for this seminar

 

 

     
 

 
     

 

  Also try the advanced seminar search tool

   FindaSeminar HomeComputer Training

unix training
training classes

 © 2002-2018 FindaSeminar.com™ All Rights Reserved.  Terms of Use |  Privacy Policy |  Training News Network

   

Custom Search