Are there any training sessions or webinars on Embase?

Medical Device 3 Part Webinar Series is titled: Cracking the Code: Demystifying EU MDR and IVDR Compliance

To find out more about this topic see the slides below:

• Demystifying EU MDR: Navigating compliance issues and achieving CE
• Navigating the IVDR Maze: From CE Certification to IVD Device Registration
• How to pass your Clinical Evaluation Assessment Report (CEAR): Creating a pragmatic systematic literature review process to assure EU MDR approval

How to get started with a CER and how to deal with a gap in the literature for your device

To find out more about this topic watch the webinar recording.

Building smart and effective biomedical literature search strategies

Biomedical literature plays a key role in the development of effective and safe drugs. To avoid missing important insights it is critical your literature search is comprehensive. Additionally, to be efficient, you would like to avoid retrieving too many non-relevant articles.

In this webinar, scientific information experts Dr. Jean Dominique Pierret (Elsevier) and Dr. Caroline Muller (Bioledge) will explain how to quickly and efficiently focus your search on what is essential to you. Wherever you work in drug development, this webinar is relevant for you.

Using different databases and real-world examples, they will explain how to work with search operators to retrieve relevant literature.

This webinar will allow you to address topics such as:

• Creating a selection of articles on bispecific antibodies for cancer treatment
• Following trends in stents for heart infarction
• Closely monitoring the safety concerns of a specific marketed drug
• Review the latest literature about the specificity of a analytical test
• And more

To find out more about this topic watch the webinar recording or view the slides(Opens in a new tab or window)

Creating the Literature Review for a Comprehensive CER

The new Medical Device Regulation calls for much stricter clinical data and a continuous process of clinical evaluation. Based on analyses of MDR 2017/745, systematic reviews of the scientific literature clearly have a lot to offer for clinical evaluations of medical devices. However, retrieving relevant and high-quality evidence from the ever-increasing volume of Biomedical literature is a challenge. Can Embase® frameworks help synthesize literature evidence from vast amount of available information for a comprehensive Clinical Evaluation Report (CER)?

Dr. Iveta Petrova discussed this in a webinar at the MedTech Digital week 2020, where she shared six sections of MDR2017/745 that propose using literature as the source of clinical data and the best practices for formulating a systematic literature search using Embase®.

This webinar discusses:

• Requirements for literature during clinical evaluation planning (under the MedDev Guideline Rev. 4 and MDR2017/745)
• Best practices on formulating your systematic literature search
• Case study on CER planning by applying the frameworks Embase offers

To find out more about this topic watch the webinar recording.

Best practices for validating literature monitoring searches

In the context of literature monitoring for adverse reactions to medicinal products (EMA GVP Module VI), a reasonable number of Market Authorization Holders have no ready answer to justify why they use each search formula for each specific product when Audit or Inspection time comes: in fact the search formula, responsible for all the inbound traffic in the Literature Monitoring process is, many times, not validated, or regularly reviewed. How does one create a “good” PV search formula for Literature Monitoring and validate it? By “good” we understand: a formula where you can justify, to an auditor or inspector, why do you use it instead of any other.

In this webinar, Elsevier senior product development manager Júlio dos Anjos will discuss the process of (re-)validation of the search formulas used for literature monitoring in the context of EMA's GVP Module VI. This will enable you to create and fine tune the search formula and, when needed, present evidence, to an auditor or inspector, on each search formula fitness for purpose.

To find out more about this topic, view the slides here(Opens in a new tab or window)

Evidence synthesis is the foundation of modern evidence-based medicine. Systematic review, a type of evidence synthesis, requires an exhaustive and comprehensive database search to identify all relevant literature on one or more research question. However, not all evidence synthesis needs a comprehensive literature search.

This presentation will give a brief introduction of different types of evidence synthesis and related requirements for literature search.

• Download the presentation slides here(Opens in a new tab or window)

Finding the right Medical Device information in Scientific Literature

In this webinar, we discussed:

• The importance of biomedical literature in preparing successful Clinical Evaluations and in remaining compliant with post-market surveillance requirements.
• How to design effective searches using Embase and Emtree.
• How trade name and manufacturer name indexing supports competitive analyses.
• Download the presentation slides here(Opens in a new tab or window)

Getting started with Embase – An introduction

In this webinar, we discussed how to use Embase for basic biomedical searches. This includes:

• Which workflows are supported by Embase and why
• An overview of content and indexing compared to Medline
• A demo in Embase of some introductory searches
• Answers to the most frequently asked questions by new users

To find out more about this topic:

• Download the presentation slides here(Opens in a new tab or window).

Embase for Pharmacovigilance: Search Strategy Creation and Validation

In this webinar, we discussed:

• Best practices for saving time, staying current, validating search strategies and mitigating risk in the face of these increasingly complex processes in literature monitoring.
• Demonstration of how to use the newly released PV Wizard search form to construct a complex PV search strategy with 5 simple steps.

To find out more about this topic, view the slides here(Opens in a new tab or window).

Systematic literature searching for evaluation of the accuracy of a new diagnostic test

To meet the clinical need of rapid and accurate diagnosis, new diagnostic tests are continuously developed and several tests are often available for the diagnosis of a particular condition. Finding good evidence regarding the performance of diagnostic tests and interpreting its value for practice is more challenging and less straightforward than for interventions. Most diagnostic studies focus on diagnostic test accuracy. However, estimates of test accuracy often vary markedly between studies. In addition, searching for studies of diagnostic test accuracy is far more difficult because the study designs vary and there is no one term that can be used to filter all diagnostic studies. Systematic reviews of diagnostic test accuracy are carried out to provide an answer to a test accuracy question based on all available evidence, to critically appraise the quality of studies, and account for and explain variations between the results of studies.

This talk will cover the question formulation and the interpretation of results of a diagnostic test study, search and selection of literature, quality assessment, meta-analysis, and finally interpretation and summary of findings.

To find out more about this topic, view the presentation slides here(Opens in a new tab or window).

Embase wouldn’t be Embase without Emtree, the life science thesaurus that provides the vocabulary that is used for Embase indexing. In this webinar, Embase Product Manager Yvonne van de Vrede discussed:

• How Emtree is built-up and managed
• How a typical article is indexed
• How drugs, diseases and devices are indexed in Embase

To find out more about this topic, see the slides of the webinar here: Embase Webinar 24 May 2017(Opens in a new tab or window).

• Drug analytics on Embase.
• Searching literature databases for Post-authorisation Safety Studies (PASS).
• Searching social media for adverse events.
• Pharmacovigilance and the role of Scientific Literature - Challenges and Solutions.
• Embase for biomedical searching – An introduction (January 2016)(Opens in a new tab or window).
• Systematic searching for medical devices made easy in Embase - 24 Sept 2014.
• Embase introduction - 13 July 2014.
• Systematic Reviews: Searching for information on adverse effects by Dr. Su Golder.
• Embase content and coverage, April 2014.