Good Clinical Practice (GCP) - Refresh (R3)
Schedule
Payment by credit card or bank transfer
BOOK & PAY DEADLINE: April 9, 2025
Early bird discount 15% for those who register by 31st of March 2025 No VAT refund. Corporate discounts: 5% for over 3 participants 10% for over 5 participants For more information please contact us at info@avantyo.com or 0726 840 456
COURSE DESCRIPTION
The GCP (Good Clinical Practice) Refresh R3 course is designed to update and refresh your knowledge on the current ICH-GCP E6 (R3) guidelines and their implementation.
This comprehensive course is meticulously aligned with the latest International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 Revision 3 guidance, which was released on January 6, 2025. It is designed to equip clinical research professionals with foundational knowledge and practical insights that can be directly applied to everyday situations in the realm of clinical research.
This course is ideal for professionals who already have a foundational knowledge of GCP and need to stay current with the latest updates. It ensures that participants are well-equipped to conduct clinical trials ethically and effectively, adhering to international standards.
The main objectives of ICH GCP Refresher R3 training include:
- Understand Key Changes: Learn significant updates in ICH GCP E6 R3 guidelines and their impact on clinical trial practices.
- Master Core GCP Principles: Refresh understanding of GCP principles, ethical considerations, and roles of sponsors, investigators, and IRBs.
- Identify New Roles & Responsibilities: Understand expanded roles of clinical trial personnel and best practices for collaboration.
- Navigate Regulatory Framework: Review global regulatory requirements and strategies for ensuring compliance in clinical trials.
- Implement Risk-Based Management: Learn risk-based approaches to clinical trial management and strategies for risk mitigation.
- Ensure Data Integrity & Quality: Discuss the importance of data integrity and quality in clinical research and best practices for accuracy and reliability.
- Facilitating mutual acceptance of clinical trial results: Harmonising standards across different regions to support global collaboration in drug development.
- Promoting transparency and accountability: Encouraging the registration of clinical trials and the reporting of results to maintain public trust.
ONLINE INSTRUCTOR-LED COURSE
Organizers: Avantyo Institute of Clinical Research
Location: Online
Duration: 2-day session
Training days: April 10-11, 2025
Training time: From 10 AM GMT+2
Language: English
Trainer: Dr. Goran Vesov, MD
Attendance only by online reservation. Booking available after registering on this site.
WHY ATTEND OUR GOOD CLINICAL PRACTICE (GCP) REFRESH R3 COURSE?
Attending our GCP Refresher R3 course offers numerous benefits for professionals involved in clinical research. Here's why you should consider it:
Comprehensive Curriculum: Our course covers all aspects of GCP, including regulatory requirements, ethical considerations, and practical implementation.
Expert Trainers: Learn from experienced professionals like Dr. Goran Vesov, who bring real-world insights and expertise to the training.
Interactive Learning: Engage in interactive sessions, case studies, and discussions to enhance your understanding and application of GCP principles.
Flexible Learning Options: Attend the course online via Zoom, making it accessible to professionals worldwide.
Stay Updated: The course provides the latest updates on GCP guidelines (ICH E6 R3), ensuring that you're aware of current best practices and regulatory requirements.
Enhance Compliance: Improve your understanding of GCP principles, ensuring that your clinical trials are conducted ethically and in compliance with international standards.
Boost Your Career: Demonstrating a commitment to continuous learning and professional development can enhance your credibility and career prospects in the field of clinical research.
Improve Trial Quality: By staying informed about the latest GCP guidelines, you'll be better equipped to conduct high-quality clinical trials that generate reliable and accurate data.
Networking Opportunities: The course provides an opportunity to connect with other professionals in the field, share experiences, and learn from each other.
Regulatory Readiness: Staying up-to-date with GCP guidelines ensures that you're prepared for regulatory inspections and audits, reducing the likelihood of non-compliance findings.
For discounts and assistance, or if you wish to be placed on a waiting list for the next course, or require any additional information, please contact us at diana.lupu@avantyo.com (+40 0726 840 456). Be sure to mention your specific educational requirements in clinical trials.
The GCP (Good Clinical Practice) refresh R3 training is designed for a diverse group of participants involved in clinical research. Here are some key profiles of participants who would benefit from this training:
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Clinical Researchers: Individuals conducting clinical trials and research studies, ensuring compliance with GCP guidelines.
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Investigators: Principal investigators and sub-investigators responsible for the conduct of clinical trials at research sites.
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Research Ethics Committee (REC) Members: Members of ethics committees reviewing and approving clinical trial protocols.
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Sponsors: Representatives from pharmaceutical companies, biotech firms, and other organizations sponsoring clinical trials.
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Clinical Research Coordinators: Professionals managing the day-to-day operations of clinical trials at research sites.
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Regulatory Affairs Specialists: Individuals ensuring that clinical trials comply with regulatory requirements and guidelines.
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Monitors and Auditors: Professionals overseeing the conduct of clinical trials and ensuring adherence to GCP standards.
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Data Managers: Individuals responsible for managing and analysing clinical trial data.
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Healthcare Professionals: Doctors, nurses, and other healthcare providers involved in clinical research.
This training aims to update participants on the latest GCP guidelines (ICH E6 R3) and ensure they are well-equipped to conduct clinical trials ethically and effectively
This comprehensive training program aims to equip participants with the refreshed knowledge of GCP principles, enhancing their ability to contribute effectively to the clinical trials process. It fosters the development of essential skills needed to navigate the complexities of clinical research, from ethical considerations to regulatory compliance and data management.
By participating in this training, professionals will be better prepared to embark on a rewarding career in clinical research, playing a crucial role in the advancement of medical science and patient care.
Dr. Goran Vesov, MD Crest Consulting LLC, North Macedonia
Dr. Goran Vesov, MD is a drug development professional with 20+ years of international experience - in big pharma, multinational CRO and as freelancer. He is currently owning and managing CResT Consulting, a clinical research quality and training consultancy, providing services to pharmaceutical companies and CROs alike.
His expertise encompasses:
- Thorough knowledge of ICH GCP and its current developments
- Experience in onboarding and advanced training of Clinical Research professionals (Sponsor, CRO and Site staff)
- Proficiency in development and implementation/follow-up of GCP Inspection readiness programs
- GCP Auditing of Clinical Investigational Sites
- Profound understanding and experience in Quality Assurance (e.g., development and update of Quality Management Systems)
- Clinical Research process improvement
- Medical Doctor degree, specialized in paediatrics and Master of science degree in paediatric endocrinology and genetics.
For previous events, please access one of the following links.
