Introduzione
The Medical Device Coordination Group (MDCG) 2024-3 guideline on Clinical Investigation Plans (CIP) set forth critical standards for designing, conducting, and reporting clinical investigations for medical devices in the European Union. Compliance with this guideline is crucial for ensuring medical devices' safety, efficacy, and 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, 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 on Clinical Investigation Plans
- Overview of MDCG and its Role
- Introduction to the Medical Device Coordination Group
- 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: 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 3: 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 4: Advanced Topics, Missed Opportunities, and Workshop (1 hour)
- 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 latest Medical Device Coordination Group (MDCG) guidelines 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
Essential clinical research experience 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
Laura C Collada Ali
Laura is an accomplished Medical Writing Manager with a proven track record of efficiently overseeing the complete process and timely delivery of critical study documents. Her expertise encompasses a wide range of materials, including protocols, informed consent documents, clinical study reports (CSRs), and other essential study materials, particularly within the realm of pharmaceuticals. She also lends her support to medical device manufacturers in drafting crucial documents such as clinical evaluation reports, post-market clinical follow-up reports, and summaries of safety and clinical performance. Laura’s passion for clear and inclusive language extends beyond her professional duties, as she has a keen interest in public-facing writing. With over 24 years of experience, she has successfully collaborated with pharmaceutical companies and medical device manufacturers across various specialties, including oncology, orthopaedics, cardiology, dermatology, infectious diseases, and more. She regularly runs workshops on her expertise domains. Her active involvement in the European Medical Writers Organization (EMWA), where she serves as an Educational Officer and member of the Executive Committee, underscores her commitment to the field of medical writing and continuous professional development.
Online Training – 2 modules
Module 1 | 13 March 2025 from 9:00 am to 12:00 pm CET
Module 2 | 14 March 2025 from 9:00 am to 12:00 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
** Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
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.
