LoginRegister
Life Science Training Institute
  • Courses
    • All Courses
    • Upcoming Live Courses
    • By Category
      • Clinical Trials
      • Manufacturing
      • Med Device
      • Regulatory
      • R&D
      • Leadership & Training
    • Meet the Instructors
  • Blog & Resources
  • About Us
    • About LSTI
    • Enterprise Solutions
      • CRA Academy
      • GxP Refresher Courses
    • FAQs
    • Contact Us
    • Email Communications
  • View Cart
  • Join Our Mailing List
  • Courses
    • All Courses
    • Upcoming Live Courses
    • By Category
      • Clinical Trials
      • Manufacturing
      • Med Device
      • Regulatory
      • R&D
      • Leadership & Training
    • Meet the Instructors
  • Blog & Resources
  • About Us
    • About LSTI
    • Enterprise Solutions
      • CRA Academy
      • GxP Refresher Courses
    • FAQs
    • Contact Us
    • Email Communications
  • View Cart
  • Join Our Mailing List
HomeOn Demand CoursesPediatric Clinical Trials: Special Considerations and Requirements

Pediatric Clinical Trials: Special Considerations and Requirements

Teachers
Chuck Sather
Category:
Clinical Trials/Regulatory & Compliance/On Demand Courses/
Clear
Duration: 90 minutes
On-Demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

Pediatric clinical research offers unique monitoring challenges when compared to adult clinical trials.  The diversity of developmental cognitive and physiological states throughout childhood, the impact of parents/guardians, and the unique regulatory restrictions placed on vulnerable populations all have consequences regarding how to approach the designing, recruiting, and monitoring of these trials.  Studies that do not take these differences into consideration are potentially doomed to slow study start-ups, unmet timelines, and potential subject injury.  Fortunately, there are ways to ensure your trials secure the right pediatric populations while establishing safety and compliance.

Historical, scientific and regulatory information will be reviewed as part of this presentation along with case scenarios to help build a better understanding of the special considerations encountered with clinical research involving children.  The presentation is divided into five parts:

  • A historical review of pertinent pediatric clinical trial legislation
  • A discussion regarding the physiological and developmental differences between various pediatric populations as compared to adults
  • A discussion of Informed Consent/Permission and Assent in various pediatric populations
  • A discussion of IRB review processes in relation to pediatric populations
  • A discussion of enrollment issues in pediatric studies and ways to avoid some of these issues
LEARNING OBJECTIVES

By the end of this presentation participants should be able to:

  1. Explain the physiological differences between pediatric populations when compared to adults and how they impact on ADME, specimen collection, and dosing
  2. Discuss considerations in protocol design when developing a pediatric clinical trial
  3. Explain some of the ethical challenges regarding how to consent younger school aged children verses older school aged children and adolescents
  4. Discuss enrollment issues and how parent perception can impact on enrollment

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone involved in designing, conducting, recruiting, or monitoring pediatric clinical trials with a particular emphasis on pharmaceuticals.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Chuck Sather
Specializes in the risk-based monitoring of pediatric and adult pharmaceutical, biologic and medical device clinical trials, in compliance and data management auditing and in training and education.

There are no reviews yet.

Be the first to review “Pediatric Clinical Trials: Special Considerations and Requirements” Cancel reply

Clear
Duration: 90 minutes
On-Demand
Includes handouts

CATEGORIES

  • Sales & Marketing (1)
  • Clinical Trials (93)
  • Manufacturing (87)
  • Med Device (54)
  • Quality (36)
  • Regulatory & Compliance (193)
  • Research & Development (67)
  • Leadership & Training (35)
  • IT & Data (31)
  • Upcoming Live Courses (13)
  • On Demand Courses (209)
  • Introductory Courses (20)
  • Special Packages (5)

TOPICS

Cleaning ValidationCleanroomClinical TrialsCloudCMOsComputer SystemsCRAsCROsData IntegrityDeviceeCTDEHRsEMAEquipmentFacilitiesFDAGCPGDPGLPGMPHIPAAHuman ErrorICHInformed ConsentInspectionsInstructional DesignManagementmanufacturingMarketingMDRmicrobial controlProcess ValidationProject ManagementQualityQuality by DesignQuality Risk ManagementRemote MonitoringRiskRisk-Based MonitoringRoot Cause AnalysisSite MonitoringSOPsTrainingTrial Master FileUpcoming Courses

Your Courses

Upcoming Live Courses

  • Clinical Quality Management Systems (QMS): Establishing A Practical & Compliant Program
  • Establishing Appropriate Quality Metrics
  • Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11
  • cGMP Compliance - Understanding The Top Drug Enforcement Trends
  • CAPA and Root Cause Analysis: Essentials Post ICH GCP E6 (R2) Addendum
  • ICH E6 Addendum R2 Team Training and Action Planning
  • Environmental Monitoring (EM) – Establishing and Improving Programs Using a Risk-based Approach

About

The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization.

We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

EMAIL COMMUNICATIONS

Get LSTI Email Communications straight to your inbox.

Sign Up Here

Contact

  • 101 Gibraltar Road, Suite 100. Horsham, PA 19044
  • 215-675-1800 (option 3)
  • info@lifesciencetraininginstitute.com

View Courses

  • Uncategorized
  • Sales & Marketing
  • Clinical Trials
  • Manufacturing
  • Med Device
  • Quality
  • Regulatory & Compliance
  • Research & Development
  • Leadership & Training
  • IT & Data
  • Upcoming Live Courses
  • On Demand Courses
  • Introductory Courses
  • Special Packages

Search Courses

Footer logo
Copyright © 1996-2017 VertMarkets, Inc. All Rights Reserved.
  • home
  • About LSTI
  • courses
  • Enterprise
  • Privacy
  • Terms
Search
This website uses cookies to ensure you get the best experience on our website. Learn moreOk