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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
As the regulatory submissions landscape evolves under pressures of COVID-19 related delays and new/updated regulatory agency requirements, companies must become more agile in evaluating current regulatory strategies. This webcast will feature an overview of best practices to create successful eCTD submissions in a rapidly changing environment. Learn how to evaluate current operational workflows and eCTD technology from Certara’s Synchrogenix regulatory operations experts on in order to navigate the current drug development environment and optimize marketing application success.
Learning Level:
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:
· Understand current trends in regulatory operations
· Be familiar with best practices to optimize regulatory workflow
· Know the must-have requirements in eCTD technology
Who Should Attend:
· Regulatory Operations
· Regulatory Affairs
· Research and Development IT
Speakers:
· Rob Labriola, senior director regulatory services, Certara Synchrogenix
Robert Labriola has over 25 years of experience in the pharmaceutical industry, with a focus on regulatory operations. His areas of expertise include leading global regulatory submission projects, building regulatory operations teams, and implementing document management/electronic submissions solutions. Mr. Labriola has been involved in the production of electronic regulatory submissions to numerous health agencies, with experience in all roles and at all leadership levels, and has directed numerous multi-company regulatory submissions for investigational and marketing applications. Mr. Labriola was an early adopter of the electronic Common Technical Document (eCTD), serving on industry regulatory technology working groups with Bio and PhRMA. He has served as a mentor and speaker to undergraduate and postgraduate students seeking life science careers and holds a Master of Science in Regulatory Affairs and Clinical Research Management. Mr. Labriola provides regulatory operations strategy, consulting, and submission support to Certara Synchrogenix clients, delivering quality services that drive clients to achieve their goals.
· Evan Richardson, director regulatory services, Certara Synchrogenix
Evan Richardson is an accomplished, results-driven regulatory affairs professional specializing in eCTD submissions, FDA interactions, and project management. With over 15 years of experience, he has a proven track record of successful regulatory submissions to a variety of regulatory authorities. Mr. Richardson joined Certara's Synchrogenix division in 2015, where he leads the Regulatory Services department and serves as a subject matter expert to ensure the timely delivery of services, mitigation of risks, and satisfaction of all clients.