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Transformation and Innovation in Regulatory Affairs

26 July 2018

Presenters

Venu Mallarapu, Practice Director, Regulatory Affairs Advisory Consulting, Cognizant Technology Solutions

Romuald Braun, Vice President – Strategy, Amplexor Life Sciences

Overview

Life Sciences organizations today are focused on addressing an increasing number of regulatory requirements which span across geographies, business activities, and functions. Moreover, the Regulatory Affairs function is key to improving document management, along with the process controls associated with regulatory submissions that increase efficiencies of the entire product development value chain and reduce time-to-market.

In this webinar, Venu Mallarapu, Practice Director, Regulatory Affairs Advisory Consulting, Cognizant Technology Solutions, will review opportunities for holistic transformation of Regulatory Affairs’ Business Processes, Data, and Platforms. He will explore ideas ranging from Robotic Process Automation, Intelligent Automation and Machine Learning to using Blockchain for Labeling Management and other submissions.

Amplexor’s Vice President – Strategy, Romuald Braun will present how the Amplexor Life Sciences Suite is evolving as a platform that can rise up to the frequently changing regulatory requirements and challenges. He will also walk through how Amplexor is driving innovation, aligned with ideas shared by Venu, in Regulatory Affairs through its Life Sciences Suite.

What You Will Learn by Attending this Webinar:
 

  • Review opportunities for holistic transformation of Regulatory Affairs’ Business Processes, Data and Platforms
  • Understand present challenges and key developments in Regulatory Affairs
  • Learn about various use cases in Regulatory Affairs to drive innovation
  • Recognize the need for any RIM platform to become the vehicle to drive innovation and transformation
  • Appreciate the need for driving innovation in regulatory affairs for holistic transformation

About the Presenters

Venu Mallarapu - Head of Regulatory Affairs Advisory Consulting at Cognizant Technology Solutions

Venu is responsible for managing the growth of Cognizant’s Regulatory Affairs Advisory Consulting services. He has more than 20 years of experience in providing thought leadership, business & IT transformation advice, and strategic consulting services to clients globally. Venu has extensive experience in clinical, regulatory, safety, quality, and compliance space in Life Sciences R&D.

 

Romuald Braun, Vice President Strategy, Life Sciences, Amplexor

Romuald has devoted his 25-year career to-date to various roles related to compliance, document management, and content management in the Life Sciences industry. He has held leadership roles both on the client side and in consulting, including delivery, sales, and project and line manager. His experiences bridge on-premise and cloud environments in Europe and the US. Romuald holds a Master’s Degree in Drug Regulatory Affairs from the University of Bonn, Germany, and a diploma in data technology from the Technical University Darmstadt, Germany.