GCP: Clinical Trial Sponsors GCP ICH E6(R3) Responsibilities (Fundamentals)
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Price: $95.00 USD |
Download Showcase your commitment to quality, compliance, safety, and professional excellence by earning a recognized certification of training.Training Program: GCP: Clinical Trial Sponsors GCP ICH E6(R3) Responsibilities (Fundamentals)Training Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced eLearning. Immediate access to training materials upon enrollment. Description:  Updated to ICH GCP E6(R3), this course gives sponsors a deep dive into their responsibilities-from trial initiation and management to financing and oversight. The latest revision outlines new expectations for qualifications, agreements, and trial monitoring.
Become a sponsor who leads trials to success while meeting every regulatory demand. Take the next step in your professional growth and earn an industry-recognized certification from Biopharma Institute -designed for professionals who want to excel in ensuring the safety and effectiveness of medicinal products. These programs not only give you up-to-date regulatory and compliance insights but also deliver practical skills that employers value. Whether you're enhancing your current role or preparing for a new opportunity, Biopharma Institute certifications are designed to set you apart in the competitive and highly regulated pharmaceutical industry. |
Outline:Course overview: Sets out the scope, objectives and notes on terminology. - Sponsor responsibilities - Duties and functions discussed in this session. - Risk-based quality management. - Selection of investigators - Trial management. - Data handling. - Record keeping. - Finance. - Compensation. - Regulatory submissions. - Management of investigational product(s). - Safety reporting. - Monitoring. - Audit. - Dealing with noncompliance. - Clinical trial reports. - Final Assessment. - Certificate of Completion. | Objectives:Who will benefit from this course? This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials. Learning objectives: - Outline GCP expectations for the preparation and design of a clinical trial - Summaries the sponsor's responsibilities for trial oversight - Describe the sponsor's responsibilities for quality management, including risk management, quality assurance and quality control - Outline measures to deal with noncompliance - Specify the sponsor's responsibilities for safety assessment and reporting - Specify the sponsor's responsibilities for the quality and supply of the investigational product(s) - Outline GCP expectations of the sponsor regarding data and records - Describe GCP expectations of the sponsor's use of computerized systems - Describe the sponsor's responsibilities for statistical programming and data analysis - Identify reports required of the sponsor | |
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