How Huvepharma Maintains Quality and Innovation in a High Growth Environment

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How Huvepharma Maintains Quality and Innovation in a High Growth Environment

This is an On-demand recording from April 2021 



Starting June 24th, 2021, the US FDA will require all your post-marketing submissions of promotional materials and submissions of promotional materials for accelerated approval products be submitted via electronic Common Technical Document (eCTD) format. The 37-page guidance by the FDA titled, “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs” defines ‘FDA-required labeling’ as any labeling reviewed and approved by FDA as part of the marketing application review process. Whether it’s your website, television advertisements, exhibits, product brochures, print adverts, etc., make sure you are prepared June 24th to successfully submit your promotional submissions and avoid common eCTD formatting errors.

Attend this webinar with Certara’s regulatory operations experts to learn the need-to-know information for providing your promotional materials submissions in the eCTD format to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling branch (APLB) in the Center for Biologics Evaluation and Research (CBER).

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.

Objective

  • Understand current trends in advertising and promotional submissions to the FDA
  • Implement best practices from Certara’s first-hand experiences of working with other Sponsors
  • Avoid common eCTD formatting errors when submitting your advertising and promotional materials
  • Recognize the must-have technical requirements in eCTD software

Who Should Attend?

  • Regulatory Operations
  • Regulatory Affairs
  • Research and Development IT
  • Commercial Marketing

Speakers

Rob Labriola

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

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.