Advanced Therapy Medicinal Products (ATMPs): Clinical Development Essentials
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About this course
Reasons to attend
This course on Advanced Therapy Medicinal Products is designed to provide you with a comprehensive understanding of the historical, clinical, and regulatory landscape for Advanced Therapy Medicinal Products (ATMPs).Our expert trainer will guide you through the key elements of Advanced Therapy Medicinal Products guidelines and their implications for clinical research, providing you with the knowledge and insights you need to navigate this rapidly evolving field.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
We provide this course in two distinct formats: Classroom OR OnlineClassroom: 1-Day face-to-face: 09:00 - 17:00 | Online: 2 webinar sessions of 3hours |
Course Description
Our course on Advanced Therapy Medicinal Products is a must-attend training for clinical research professionals who are looking to take their knowledge and skills to the next level. If you want to stay ahead of the competition and excel in this rapidly evolving field, this course is for you. Our expert instructors will guide you through the complex and ever-changing clinical and regulatory landscape for Advanced Therapy Medicinal Products (ATMPs). You will gain a deep understanding of the requirements for manufacturing, clinical trials, and marketing authorization of ATMPs, as well as the challenges and opportunities of developing these innovative life-saving therapies. Our instructors are industry experts with extensive experience in ATMP regulations and clinical research. They will provide you with valuable insights, practical strategies, and real-world examples that you can apply to your own work. By attending our course on ATMP, you will gain a competitive advantage and position yourself as a leader in this dynamic and rapidly evolving field. You will also have the opportunity to network with other like-minded professionals, exchange ideas, and build valuable connections. Don't miss out on this transformative experience. Register now for our one-day course on ATMP and take the first step towards advancing your career in clinical research!Programme highlight
- History and Overview of ATMPs
- Quality and regulatory requirements for ATMPs
- ATMP development pathways
- Challenges in developing and testing ATMPs
- Key considerations for clinical trials with ATMPs
- Ethical, legal, and social implications of ATMPs
- Examples of key ATMPs development
Learning objectives
- Understand what are ATMPs and their history as well as the regulatory framework and the requirements for their development, clinical trials, and marketing authorisation.
- Learn about the challenges and opportunities of developing ATMPs and regulatory compliance.
- Develop an understanding of the ethical, legal, and social implications of ATMPs, including patient privacy, informed consent, and access to therapy.
- Identify key considerations for the design and conduct of clinical trials with ATMPs, including safety, efficacy, and clinical endpoints.
- Explore case studies and engage in group discussions to gain insights and share experiences with other professionals in the field.
Who should attend
This course is intended for researchers, clinicians, and industry professionals who are involved or interested in the development and clinical testing of ATMPs with no or little experience. In particular, the following professionals will benefit greatly from attending this course:
- Biotech and pharmaceutical company executives and staff involved in clinical research and development of ATMPs.
- Regulatory affairs professionals involved in preparing, submitting, and managing ATMP-related regulatory documents to the regulatory authorities.
- Clinical research professionals including clinical operations, clinical research associates, clinical study coordinators and investigators, involved in planning and conducting clinical trials with ATMPs.
- Academicians and researchers in the fields of cell and gene therapy, tissue engineering, and other related areas of research.
- Professionals involved in healthcare and patient advocacy groups, who want to understand the latest developments in ATMP regulations and the impact on patient care.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design
- Ethical & Participants Safety Considerations
- Investigational Product Development and Regulation
- Clinical Studies Operations (GCPs or ISO 14155)
- Study and Site Management
- Data Management and Informatics
- Leadership and Professionalism
- Communication
- Teamwork
- Business acumen
Trainers
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