The literature review is a fundamental, but often poorly executed, component of a clinical evaluation report (CER) for medical devices. With regulatory bodies increasing their scrutiny of literature reviews and CERs in general, organizations are looking for new ways to consistently deliver regulatory compliant, audit-ready literature reviews on time and on budget.
This webinar will cover practical, proven methods for building a predictable, cost-effective and standardized literature review process. The presenters will leverage the DistillerSR software platform to provide living examples of best practices and to illustrate the application of specialized software in this domain.
If you are involved in CER preparation or literature reviews in general, this is an opportunity to increase your understanding of the processes, best practices and potential pitfalls associated with them. Even experienced staff will pick up new, practical methods that will improve their day-to-day processes and make their work more valuable.
Peter O’Blenis, President, Evidence Partners
A firm believer that well-written web-enabled software can solve real-world problems, Peter O’Blenis co-founded Evidence Partners in 2008 to do just that. In 2001, Peter co-founded TrialStat, where he co-wrote SRS, the first commercially available systematic review software package. He has worked with over 150 research groups around the globe and has published and presented globally on best practices and methodologies for using web-based software to streamline clinical research, including several patent pending approaches.
Peter has served in senior management roles with Oracle, WebGain, Mitel and Flick Software. He holds an MBA from Queen’s University and a Bachelor of Computer Science from Carleton University and has also completed post-graduate courses in Clinical Pharmacology, Drug Development and Regulation, and Clinical Research at Tufts University.
Dr. Isabella Steffensen, President, Thera-Business Consulting
Dr. Isabella Steffensen is a biomedical scientist with a B.Sc. Honours Biology (cum laude) and Ph.D. in Cellular Biology from the University of Ottawa. She completed a postdoctoral fellowship with a leading neurologist at the Ottawa Health Research Institute where she performed research on stroke and spinal cord injury. Over the past 20 years, Dr. Steffensen has assisted pharmaceutical and medical device companies with technical, regulatory, marketing, and business development issues. She has extensive experience preparing clinical evaluation reports and other regulatory documents, as well as other evidence based-reports such as practice guidelines and systematic reviews. She is an expert at Clinical Evaluation Report remediation and helping medical device companies fulfill current regulatory requirements in the European Union. She has completed hundreds of projects for developers of therapeutic agents and medical devices, and government health agencies.
Who Should Attend?
Regulatory & medical communications professionals who are involved in the preparation of Clinical Evaluation Reports to comply with regulatory requirements
What You Will Learn
Upon the webinar’s conclusion, you will be able to:
- Understand and apply best practices for completing the literature review component of CERs
- Establish standard, repeatable processes for conducting literature reviews throughout your group or your entire company
- Consistently and efficiently produce and maintain fully compliant and audit ready literature reviews
Evidence Partners is the creator of DistillerSR, the world’s most widely used literature review software. DistillerSR helps regulatory groups manage fully compliant and audit-ready literature reviews quickly and easily.