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Site language : English - Français
Ref : 29373
Event :How to Manage Your Vendors in Clinical Research

Date :Thursday April 25th, 2019

Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Editorial

This vendor management webinar will show you how to choose the right vendor, onboarding and set up, manage vendor performance, manage issues and ensure compliance with current FDA regulations and ICH guidelines and have a smooth-running clinical study.

Objectives

Sponsors are responsible for vendor oversight, but how is this accomplished? Sponsors are outsourcing more clinical research processes, and they need to have both the team and processes in place to bring on vendors and manage them to be compliant and ensure a cohesive team approach.

This presentation will instruct the participant on how to ensure the correct vendor for their organization and clinical study. The process starts with a cohesive team for the sponsor to define vendor specifications, internal and external planning, pre-selection, evaluating, negotiation, contracting and selection.

Program

Areas Covered in the Webinar:

The webinar will begin with a regulatory overview of sponsor responsibilities This will be followed by explanation on how to choose the right vendor. Finally, Best Practices for creating, implementing and maintaining tools to ensure the correct vendor is chosen for the sponsor requirements.

  • What do the Regulations mean?
  • Vendor oversight – Where do you start?
  • Vendor management as a team approach
  • Defining requirements
  • Quality insight and input
  • Pre-Qualification of a vendor
  • Use of Tools and Processes
  • Managing vendor performance
 

Free Materials:

  • Reference documents
  • Rule documents or guidance
  • Checklist
  • Articles

Speakers

 
Pam Dellea Giltner

Pam Dellea Giltner
CCEO, PDG Clinical Consulting LLC

Pam Dellea-Giltner is CEO and principal auditor of PDG Clinical Consulting LLC. She has over 30 years of experience in all aspects of Clinical Research Operations. Experience includes Quality Assurance/GCPs, Pre-Inspection Readiness/Audit Reponses, Project Management, Phase I-IV, post marketing and epidemiology studies, Study Management, Vendor/CRO Set up and management.

She has held positions in both pharmaceutical and CRO companies including GCP Auditor, Project Manager, Clinical Research Associate, and Trial Manager.

Currently she is Chairman of the ACRP CCRA Examination Committee and has been a certified CCRA since 2009.

 
 
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Location

Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

Further information

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Details

How to Manage Your Vendors in Clinical Research Management - Management & Taxation
vendor management, clinical trial vendor management, clinical trial vendor set up, clinical trial vendor qualification, clinical vendor oversight plan, vendor selection and management in clinical trials, clinical trial vendor selection
CEO Contract VPs Quality VPs IT VPs Contract personnel Regulatory Affairs Professionals Quality Mangers GXP Consultants
10 -- --
English

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