Using Electronic Health Records and Claims Databases for Rapid-Response Pharmacovigilance Studies
Alan Hochberg
60 Min
Product Id: 700972
This presentation will give an overview of these new tools and techniques for the non-statistician/epidemiologist. It is vital that a pharmaceutical manufacturer be able to quickly assess these issues on a sound statistical basis, in a way that eliminates bias due to confounding factors as much as possible.
Clinical Research Organization Audit for Good Clinical Practice
Ronald Schoengold
90 Min
Product Id: 700907
This Webinar defines the role of the CRO to ensure that each party is meeting its responsibilities. CRO audits ensure that the study data and results are credible and accurate, and that the rights and well-being of study subjects have been protected.
Organization of Clinical Datasets in eCTD Submissions
Antoinette Azevedo
90 Min
Product Id: 700992
This presentation will review the documentation requirements, the electronic navigation aids required for all the components of the electronic datasets package for a clinical study. This webinar will provide valuable assistance to all pharmaceutical and biotechnology that are conducting clinical studies with the intent of filing Investigational New Drug (IND) and New Drug Applications (NDA) or Biological License Applications (BLA) submissions.
Data and Safety Monitoring in Clinical Research Involving Human Subjects - When and How
Charles H Pierce
90 Min
Product Id: 700924
This webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. All Clinical Research protocols have a prominent safety monitoring plan as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.
Utilizing ICH Guidelines for GCP Regulatory Compliance
Carl Anderson
60 Min
Product Id: 700855
This presentation reviews key ICH guidelines to directly correlate them with FDA Compliance Program Guidance Manuals that FDA investigators use to conduct GCP inspections. This webinar will provide critical assistance to FDA regulated companies currently conducting or preparing to conduct clinical trials.
Preparing Compliant eCTD Submissions
Antoinette Azevedo
60 Min
Product Id: 700719
This webinar will provide valuable assistance to all companies regulated by FDA to understand the current and impending requirements for electronic submissions. The immediate impact is to companies submitting INDs and marketing applications for pharmaceutical and biological products.
Validation of Computerized Analytical Systems
Dr. Ludwig Huber
60 Min
Product Id: 700212
This Validation training will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.
Implementing Clinical Trial Performance Metrics
Dr. Carla Hagelberg
60 Min
Product Id: 700182
This Clinical Trial training will helps in implementing Metrics that can be used as clinical trial performance improvement indicators.
CLIA Compliance - From Quality Control to Inspections - Comprehensive Training Package (3 Courses)
Barry Craig
Product Id: 702293
This comprehensive training package of three courses is aimed at helping clinical laboratories ensure compliance with CLIA requirements.
How to Buy COTS Software, and Audit and Validate Vendors
David Nettleton
Product Id: 703820
This training program will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and to evaluate a software vendor. It will also highlight key data and systems subject to Part 11, and list requirements for IT, SaaS, and cloud hosting.
Key Factors to Develop an Effective CAPA System
Kim Huynh-Ba
Product Id: 703320
This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.
Clinical Trials Monitoring - Comprehensive Training Package (4 Courses)
Carol Owen,Kimberly Kiner,Arash Amirpour,Charles H Pierce
Product Id: 702298
This comprehensive training package of four courses covers clinical trial monitoring techniques, audit procedures and the setting-up of Data Monitoring Committees (DMCs).