Attestato di partecipazione
Introduzione
The State of the Art section is not a new requirement under the EU MDR 2017/745. However, the provisions for this section have been enforced, and it has become the fundament of the Clinical Evaluation Report. The State of the Art section needs to identify benchmark devices besides information about the medical background, clinical conditions, and alternative therapies related to a medical device. Data about these benchmark devices are relevant to define safety and performance parameters and acceptance criteria. These criteria compare the subject medical device to the current State of the Art.
This requires a thoroughly structured systematic literature search and a deep understanding of the medical conditions related to the subject device.
Understanding the relevant parts of a State of the Art section and knowing where to start can be challenging.
Also, as a medical device professional, you may face devices with little background information for which the literature search can become challenging.
This workshop will give you profound insights into the State of the art's regulatory requirements, best practice recommendations on how to structure your search, and how to identify your benchmark devices and parameters.
- Brief introduction: Regulatory framework; content and structure
- Benchmark devices and benchmark parameters for safety and performance
- Tricky case studies and how to deal with them: novel devices; devices with no published data; artificial-intelligence-based devices; software medical devices; and so on…
- Systematic literature searches for the State of the Art
- How to compare the State of the Art information to the subject device
- Review cycles and updates
- Can Language Automation Models (artificial intelligence [AI]) help us draft the State of the Art?
This course is intended for medical device professionals who already have some experience of the MDR requirements for writing Clinical Evaluation Reports, including State of the Art Sections, and are looking for advanced training to better understand their strategic relevance.
Participant experience
We will assume that participants have a good knowledge of the directives and regulations governing medical devices, such as the MDR.
The lecturer will deliver short presentations on the program topics. Questions and subsequent discussions are welcome at any time during the workshop.
A series of polling questions will illustrate participants’ ideas and perceptions on the topics presented.
In breakout rooms, small groups of participants will have the chance to work on exercises related to the State of the Art section.
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 | 10 October 2024 from 9:00 am to 11:30 am CEST
MODULE 2 | 11 October 2024 from 9:00 am to 11:30 am CEST
Some days before the online training 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: € 510,00* until 10/09/2024
Ordinary: € 645,00*
Freelance – Individual – Academy – Public Administration**: € 380,00*
*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.
Registrati
Barbara Rossi
Training & Quality 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.