Introduction
This course provides an in-depth understanding of regulatory requirements, ethical considerations, and best practices for clinical trial compliance, ensuring adherence to Good Clinical Practice (GCP), FDA, EMA, and ICH guidelines.
Duration:
5 Days
Personal Impact
- Enhanced knowledge of clinical trial regulations and compliance.
- Improved ability to manage ethical and legal aspects of trials.
- Increased opportunities for career advancement in clinical research.
Organizational Impact
- Improved compliance with global clinical trial regulations.
- Reduced risk of non-compliance penalties and regulatory issues.
- Strengthened clinical trial integrity and data reliability.
Target Audience:
- Clinical research associates (CRAs) and coordinators.
- Regulatory affairs professionals.
- Pharmaceutical and biotech professionals.
Course Level:
Course Objectives
By the end of the course, participants will be able to:
- Ensure compliance with global regulatory standards (FDA, EMA, ICH-GCP).
- Understand the ethical principles governing clinical trials.
- Manage clinical trial documentation and audit readiness.
- Implement risk-based monitoring and quality assurance in trials.
Modules
Module 1: Fundamentals of Clinical Trial Compliance
- Overview of Good Clinical Practice (GCP) and ICH guidelines.
- Key regulatory bodies: FDA, EMA, WHO, MHRA.
- Hands-on Exercise: Identifying compliance risks in clinical trials.
Module 2: Regulatory Submissions and Approvals
- IND, NDA, and BLA applications.
- Institutional Review Board (IRB) and Ethics Committee (EC) approval process.
- Hands-on Exercise: Preparing a regulatory submission checklist.
Module 3: Risk-Based Monitoring and Audit Readiness
- Implementing risk-based monitoring (RBM) strategies.
- Preparing for regulatory inspections and audits.
- Hands-on Exercise: Conducting a mock clinical trial audit.
Module 4: Quality Assurance in Clinical Trials
- Developing clinical quality management systems (CQMS).
- Managing protocol deviations and corrective actions.
- Hands-on Exercise: Writing a Corrective and Preventive Action (CAPA) plan.
Module 5: Ethical Considerations and Future Trends
- Ethical challenges in clinical trials.
- Digital transformation and AI in clinical research compliance.
- Hands-on Exercise: Drafting an ethical compliance policy.
Related Courses
Course Administration Details:
Methodology
These instructor-led training sessions are delivered using a blended learning approach and include presentations, guided practical exercises, web-based tutorials, and group work. Our facilitators are seasoned industry experts with years of experience as professionals and trainers in these fields. All facilitation and course materials are offered in English. Participants should be reasonably proficient in the language.
Accreditation
Upon successful completion of this training, participants will be issued an Indepth Research Institute (IRES) certificate certified by the National Industrial Training Authority (NITA).
Training Venue
The training will be held at IRES Training Centre. The course fee covers the course tuition, training materials, two break refreshments, and lunch. All participants will additionally cater to their travel expenses, visa application, insurance, and other personal expenses.
Accommodation and Airport Transfer
Accommodation and Airport Transfer are arranged upon request. For reservations contact the Training Officer.
- Email: [email protected]
- Phone: +254715 077 817
Tailor-Made
This training can also be customized to suit the needs of your institution upon request. You can have it delivered in our IRES Training Centre or at a convenient location. For further inquiries, please contact us on:
- Email: [email protected]
- Phone: +254715 077 817
Payment
Payment should be transferred to the IRES account through a bank on or before the start of the course. Send proof of payment to [email protected]
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