Introduction
This course provides an in-depth overview of global regulatory requirements for clinical research, focusing on FDA, EMA, ICH, WHO, and MHRA guidelines.
Duration:
5 Days
Personal Impact
- Improved knowledge of clinical trial regulatory frameworks.
- Strengthened skills in regulatory submissions and compliance.
- Increased career growth opportunities in clinical regulatory affairs.
Organizational Impact
- Faster approval processes for clinical studies.
- Reduced regulatory compliance risks and penalties.
- Enhanced reputation for clinical research compliance.
Target Audience:
- Regulatory affairs professionals.
- Clinical research associates (CRAs) and investigators.
- Biotech and pharmaceutical executives.
Course Level:
Course Objectives
- Navigate regulatory pathways for clinical trial approval.
- Ensure compliance with ICH-GCP, FDA, and EMA regulations.
- Prepare and submit clinical trial applications (CTA, IND, NDA).
- Understand regulatory inspection and audit expectations.
Modules
Module 1: Introduction to Global Regulatory Frameworks
- Overview of FDA, EMA, ICH-GCP, WHO, and MHRA guidelines.
- Phases of clinical trial approval processes.
- Hands-on Exercise: Comparing global regulatory requirements.
Module 2: Preparing Clinical Trial Applications (CTA, IND, NDA)
- Key components of Clinical Trial Applications (CTAs).
- Investigational New Drug (IND) and New Drug Application (NDA) process.
- Hands-on Exercise: Drafting an IND submission.
Module 3: Regulatory Compliance in Clinical Trials
- Managing protocol deviations and regulatory inspections.
- Implementing CAPA (Corrective and Preventive Actions).
- Hands-on Exercise: Conducting a clinical compliance self-audit.
Module 4: Clinical Trial Audits and Regulatory Inspections
- Understanding FDA and EMA inspection processes.
- Preparing for clinical site inspections and audits.
- Hands-on Exercise: Developing an inspection readiness plan.
Module 5: Digital Innovations and Future Regulatory Trends
- AI and blockchain in clinical trial regulatory compliance.
- Decentralized clinical trials and digital health regulations.
- Hands-on Exercise: Drafting a risk management plan for digital trials.
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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