Major Changes in GCP from ICH E6(R2) to (R3): Road Map
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Price: $225.00 USD |
Download Showcase your commitment to quality, compliance, safety, and professional excellence by earning a recognized certification of training.Training Program: Major Changes in GCP from ICH E6(R2) to (R3): Road MapTraining Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced eLearning. Immediate access to training materials upon enrollment. Description:  Stay ahead of the curve with our in-depth training on the newly revised ICH GCP E6(R3) guidelines. This course dives into the latest changes, integrating key concepts from ICH E8(R1) and emphasizing Quality by Design, a tailored approach to trial conduct, and reducing unnecessary burdens. Instead of simply ticking boxes, you'll learn to apply critical thinking, strengthen vendor oversight, ensure robust e-system validation, and maintain a risk-based approach throughout clinical trial operations.
Ideal for experienced clinical research professionals, with additional guidance for those new to GCP. Take this course to confidently implement the changes and strengthen compliance across your programs. 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:Instructions Welcome to Good Clinical Practice Training, ICH E6(R3). E6(R3) is the global standard for Good Clinical Practice. Compliance to this standard supports study participant safety, data reliability, and inspection preparedness. Quality by Design Key topics include discussion about the identification of Critical to Quality factors informs a risk-based, Quality by Design approach to support efficient and high-quality clinical trials. Introduction to GCP and GCP Principles Key topics include expansion and addition of principles, ICH E8(R1) incorporation in the guideline, new and changed terminology, critical to quality factors and least burdensome approach. The Appendices Key topics include the Protocol and protocol amendments, Investigator's Brochure, and Essential Records. Investigator Responsibilities, Ethics Committees and Informed Consent Key topics include roles and responsibilities, qualification and training, participant protection and informed consent process, source documents, investigational product (blinding/unblinding), communication with the ethics committee and sponsor, ethics committee approval and oversight. Sponsor Responsibilities Key topics include roles and responsibilities, monitoring, study design, site and investigator selection, training, managing non-compliance, and safety reporting. Data Governance and Computerized Systems Key topics include data life cycle, audit trails, good documentation practices, and electronic systems i.e. procedures and training, security, validation, and access controls. Maturity Model Key topics include Maturity Model application, culture, training, design and conduct assessment and critical thinking skills. Scenarios & Post Assessment Now that the lecture portion of the course is complete, it is time to apply your knowledge with real-life case scenarios. Feel free to return to the previous parts of the course to review content to help you answer the questions. They are not graded, but the correct answers will be covered after you have the chance to answer them. | Objectives:Learning Objectives: - Identify important changes to GCP per the ICH E6(R3) guideline. - Discover how the changes in the Guideline affect organizational processes and stakeholder roles and responsibilities. - Consider ways of planning for implementation. Course Length: 3.5 hours | |
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