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This is an On-demand
recording from October 2020.
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.
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.
Understand current trends in regulatory operations
Be familiar with best practices to optimize regulatory
Know the must-have requirements in eCTD technology
Research and Development IT
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,
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.