🇨🇿 A review of professional literature: fundamentals and practical experience

The event is held in Czech language only!

Literature reviews play a crucial role in demonstrating the safety and efficiency of medical devices and represent one of the frequently assessed elements of clinical evaluations. A properly conducted review allows for the identification of relevant clinical data, description of the state of the art (SOTA), evaluation of known risks and adverse effects, and, in some cases, a significant reduction in the need for new clinical trials. Regulatory practice places increasing emphasis on the quality, transparency, and repeatability of literature reviews. An insufficiently defined search procedure, a lack of justification for the selection of studies, or an unclear link to the assessment of safety and efficiency are among the frequent comments made by notified bodies and supervisory authorities.

This webinar will provide a comprehensive overview of how to properly plan, conduct, and document a literature review so that it is regulatory defensible and practically applicable to clinical evaluations of medical devices. 

Emphasis will be placed on the correct setting of criteria and keywords, working with databases, evaluating the quality of evidence, and creating a clear Literature Search Report that will stand up to audit or technical documentation assessment.

Who the webinar is for:

• Regulatory specialists of the manufacturer

• Clinical trial specialists

• Experts involved in the creation or revision of clinical documentation

• Anyone working in the medical device field who wants to broaden their horizons in this area

Lecturers:

• Mgr. Sidónia Molitorisová

• Ing. Kateřina Sinevičová

Content:

• The role of literature review in clinical evaluation

• Working with appropriate databases and keywords

• Search strategies and procedure documentation

• Citation managers

• Correct criteria for inclusion and exclusion of studies, level of evidence quality

• Creation of a literature search report and its use in documentation

• Shortcomings and how to prevent them in technical documentation

  
  

Additional information:

• During the webinar, participants will have the opportunity to ask questions

• Each participant will receive a certificate of participation

• A PDF presentation will be sent to all participants

Participation fee:

• 3.900 CZK excluding VAT

• 100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant

Webinar hosted by:

• Porta Medica s.r.o.

• ID: 03301931, VAT: CZ03301931

• Registered office: Opletalova 1525/39, 110 00, Prague 1 - Nové Město