Clinical Evaluation Report (CER) literature reviews are a critical component of our regulatory submission process. It is a fundamental but often poorly executed component. 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. It is important that we continue to find new and better ways to deliver our reviews in a predictable and audit-ready fashion.
This webcast will cover practical, proven methods for building a predictable, cost-effective and standardized lit review process. The webcast 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 you understanding of the processes, best practices and potential pitfalls associated with them.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Upon the webcast'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
Who should attend
- Regulatory and medical communications professionals who are involved in the preparation of CERs to comply with regulatory requirements
Peter O’Blenis, president, Evidence Partners
Isabella Steffensen, PhD, president, Thera-Business Consulting