This is an On-demand recording from March 2020.

 

 

The 26 May 2020 deadline for EU MDR implementation is quickly approaching along with the need to conduct and maintain living literature reviews. As a regulatory professional, you may be struggling to find ways to meet the new—and vastly increased—requirement for clinical evidence. With time at a premium and CER experts even more so, you need to focus on creating efficiencies in the literature review process.

 

According to a recent RAPS/KPMG survey, a whopping 83% of respondents cited “remediating and managing updates to technical files and Clinical Evaluation Reports” as a significant challenge. This webcast will review simple, pragmatic approaches and tools to focus on the high value work of CER preparation by reducing the time to complete low value administrative tasks such as retrieval and management of references/citations and full text articles in living literature reviews.

 

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.

Learning Objectives

• Upon conclusion of the program, you will be able to:
• Understand the role of living literature reviews in meeting clinical evidence requirements for EU MDR compliance
• Identify inefficiencies in current literature review processes
• Gain an understanding of available tools to automate time and labour-intensive aspects of the literature review process

 

Who Should Attend?

• Regulatory professionals involved in the preparation of clinical evaluation reports or other regulatory submissions requiring literature review

Speakers

Peter O'Blenis, chief executive officer, Evidence Partners

Peter O’Blenis co-founded Evidence Partners in 2008 to develop leading edge technology that helps researchers deliver higher quality evidence, faster. The company’s core product, DistillerSR, is now the world’s most widely used literature review software.

As a pioneer in literature review automation, Peter’s passion for the subject has made him a sought-after speaker and resource. He has worked with over 250 research groups around the globe since 2001 and has published extensively on best practices and methodologies for using technology to improve the review process.

Peter previously held 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.

 

Rogier van Erkel, chief sales officer, Research Solutions

Mr. van Erkel has 12 years of sales management experience at Elsevier, an information and analytics company, and one of the world's major providers of scientific, technical and medical information. In his most recent role, he served as sales director, leading a global team and agent network. He managed a diverse sales portfolio consisting of four product groups selling to businesses all over the world. In that role, he specialized in information products, input for discovery tools and solutions to optimize and maximize customer workflow. He also served in other senior sales roles in Elsevier and before that, managed sales and operations teams for five years at Renewi (formerly Van Gansewinkel), a leading waste management company operating across Europe. Mr. van Erkel earned his degree from the University of Amsterdam and his Bachelor of Arts in Business Economics from Hanze University of Applied Sciences Groningen.