Introduzione
The Medical Device Coordination Group (MDCG) 2024-3 guidance provides best practices for preparing clinical investigation plans (CIPs) for medical devices in the European Union. Compliance with the Medical Device Regulation (MDR) is mandatory for clinical investigations taking place in the European Union, and the ISO 14155 standard is useful for sponsors when planning and developing their clinical investigations.
Having sufficient knowledge about MDR, the MDCG 2024-3 and the ISO 14155 standard is therefore crucial for creating accurate and compliant CIPs, ensuring medical devices' safety and performance, and bringing them closer to regulatory approval.
This comprehensive training course is designed for clinical researchers, regulatory affairs professionals, and medical writers who prepare and submit CIPs. Over the course of six hours, participants will gain a thorough understanding of the MDCG 2024-3 guideline, recognize overlaps with the normative Annex A of ISO 14155, learn best practices for CIP development, and acquire practical skills to enhance the quality and compliance of their clinical investigations.
Session 1: Introduction to the MDCG Guideline
- Overview of MDCG and its Role
- Introduction to the MDCG
- Importance of MDCG guidelines in the regulatory landscape
- Detailed Review of the MDCG 2024-3 Guideline
- Scope and objectives of the guidelines
- Key definitions and terminology
- Regulatory Context and Requirements
- EU regulatory framework for medical devices
- Relationship between CIPs and other regulatory documents
- What has changed as compared to previous guidelines and standards?
Session 2: Introduction to ISO 14155 and the relevant parts for CIPs
- Overview of ISO 14155 and its updates
- Introduction to international standards
- ISO 14155:2020 and the new ISO/DIS 14155:2024
Session 3: Structuring a Clinical Investigation Plan
- Essential Elements of a CIP
- Objectives, hypotheses, and endpoints
- Study design and methodology
- Participant selection and recruitment
- Ethical Considerations and Risk Management
- Informed consent process
- Risk-benefit analysis and safety monitoring
- Data Management and Statistical Analysis
- Data collection methods and management plans
- Statistical analysis plans and interpretation of results
Session 4: Practical Application and Case Studies
- Developing a CIP: Step-by-Step Guide
- Practical steps in drafting a comprehensive CIP
- Common pitfalls and how to avoid them
- Case Studies and Examples
- Analysis of exemplary CIPs passages
- Group exercises on identifying and correcting CIP deficiencies
- Interactive Q&A Session
- Addressing participant questions and concerns
- Sharing experiences and best practices
Session 5: Advanced Topics, Missed Opportunities, and Workshop
- Advanced Considerations in Clinical Investigations
- Adaptive trial designs and innovative methodologies
- Handling amendments and deviations in CIPs
- Missed Topics and Opportunities in the MDCG Guideline
- Identifying gaps and areas for improvement in MDCG 2024-3
- Emerging trends and technologies not covered by the guidelines
- Strategies for integrating innovative practices within the existing framework
- Workshop: Writing and Reviewing CIPs
- Hands-on writing session to draft CIP sections
- Peer review and constructive feedback
Final Discussion and Wrap-Up
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- Summary of key learnings
- Resources for further reading and support
- Feedback collection
The course is aimed at individuals responsible for ensuring compliance with the MDR and clinical investigations in the European Union and those looking for in-depth knowledge of the MDCG guidance on Clinical Investigations for Medical Devices. This training will benefit anyone looking to stay current with the regulatory requirements and best practices in the medical device industry.
Participant experience:
Knowledge of clinical research would be beneficial.
This online training course will be conducted through an interactive virtual platform, ensuring a dynamic and engaging learning experience. The course will include live lectures, group discussions, and hands-on exercises designed to reinforce learning and facilitate the practical application of the concepts.
Docente/i
Diana Ribeiro
Diana started her career as a pharmacy technician, then completed her training as a pharmacist in the Faculty of Pharmacy of the University of Lisbon. She also obtained a post-graduate degree in Phytotherapy and a professional certification as a Clinical Research Associate.
After working in healthcare for more than 15 years, Diana became a freelance medical writer in 2019, working on both medical communications and regulatory documents.
To keep updated with the latest developments and further her knowledge in the medical writing and regulatory areas, Diana is an active member of both the European Medical Writing Association (EMWA) and the Regulatory Affairs Professionals Society (RAPS).
She is also a member of the Association of Health Care Journalists (AHCJ), where she gains valuable insights about communicating with the public.
Online Training – 2 modules
Module 1 | 12 March 2025 from 02:00 to 05:00 pm CET
Module 2 | 13 March 2025 from 02:00 to 05:00 pm CET
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 680,00* (until 20 February 2025)
Ordinary: € 875,00*
Freelance – Individual – Academy – Public Administration*: € 495,00*
* for Italian companies: +22% VAT
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Roberta Alberti
Events & Training Manager
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
