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 1. Eventura World
 2. Courses
 3. Data Integrity For In Vivo Bioavailability And Bioequivalence (BA/BE)
    Studies


DATA INTEGRITY FOR IN VIVO BIOAVAILABILITY AND BIOEQUIVALENCE (BA/BE) STUDIES

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🎤  G. Sundar        |  📅  July 24, 2024   |  🕒  11 AM Eastern Time US



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WHO SHOULD ATTEND: 

 * Quality Assurance Departments
 * Quality Control Departments
 * Regulatory Affairs Departments
 * Clinical Research Organizations (CROs)
 * Clinical Operations Professionals
 * Data Management Professionals
 * Research & Development Departments
 * Laboratory Management Professionals
 * IT/Technology Departments
 * Compliance Departments
 * Pharmacokinetics Professionals
 * Everyone involved in conducting or overseeing in vivo bioavailability and
   bioequivalence studies.

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Description:

This session is designed to provide participants with a comprehensive
understanding of data integrity requirements specific to in vivo bioavailability
and bioequivalence (BA/BE) studies, which are crucial in pharmaceutical
research. Data integrity is paramount in ensuring that the results of these
studies are accurate, reliable, and compliant with regulatory standards.

The webinar will begin with an introduction to the importance of data integrity
in pharmaceutical research, particularly in BA/BE studies. Participants will
then receive an overview of relevant guideline documents, including their
purpose, scope, and key sections. The session will delve into fundamental
concepts of data integrity, such as accuracy, completeness, and reliability, and
illustrate these concepts with practical examples.

The regulatory requirements and best practices for data management,
documentation, and reporting in BA/BE studies will be thoroughly reviewed.
Guidance on maintaining electronic records and implementing data security
measures will be provided. The session will also feature case studies and
real-life examples to highlight common data integrity issues and discuss root
causes and potential solutions.

Quality control (QC) and quality assurance (QA) roles in ensuring data integrity
will be examined, with examples of QC/QA procedures relevant to BA/BE studies.
The webinar will conclude with a Q&A session, allowing participants to seek
clarifications and discuss specific challenges they face in ensuring data
integrity.

The technical knowledge and tips provided in this webinar will help participants
enhance their data management practices, ensuring that their BA/BE studies meet
regulatory standards and produce reliable results. By attending, you will gain a
deeper understanding of the importance of data integrity in pharmaceutical
research and be better equipped to implement effective data management
strategies in your studies.




Areas Covered in the Session:   

 * Introduction to Data Integrity
   * Define data integrity and its significance in pharmaceutical research.
   * Discuss the importance of data integrity in in vivo bioavailability and
     bioequivalence studies.
 * Overview of the Guideline
   * Provide an overview of the guideline document.
   * Explain the purpose, scope, and regulatory context of the guideline.
   * Highlight key sections and topics covered in the document.
 * Fundamental Concepts of Data Integrity
   * Define fundamental concepts related to data integrity, such as accuracy,
     completeness, and reliability.
   * Discuss the principles of Good Clinical Practice (GCP) and Good Laboratory
     Practice (GLP) concerning data integrity.
   * Provide examples to illustrate each concept and its application in
     bioavailability and bioequivalence studies.
 * Regulatory Requirements and Best Practices
   * Review regulatory requirements outlined in the guideline for ensuring data
     integrity.
   * Discuss best practices for data management, documentation, and reporting in
     bioavailability and bioequivalence studies.
   * Provide guidance on maintaining electronic records and implementing data
     security measures.
 * Case Studies and Examples
   * Present case studies or real-life examples of data integrity issues in
     bioavailability and bioequivalence studies.
   * Analyze each case study, identifying root causes and potential solutions.
   * Facilitate group discussions to encourage participants to share their
     insights and experiences.
 * Quality Control and Quality Assurance
   * Explain the roles of quality control (QC) and quality assurance (QA) in
     ensuring data integrity.
   * Discuss the importance of QC/QA measures in preventing and detecting data
     integrity issues.
   * Provide examples of QC/QA procedures relevant to bioavailability and
     bioequivalence studies.








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