Sponsored: An integrated approach to regulatory submissions

Sponsored: An integrated approach to regulatory submissions
FREE SPONSORED WEBINAR - The success of regulatory submissions is dependent on the close collaboration between regulatory, supply, and quality teams. Breaking down silos, and working together to plan and execute effective marketing authorization supply transfers (MAST) enables a seamless supply of compliant drugs and devices to reach patients around the world.

Date: 27 October 2021
Time: 14.00 - 15.00pm (BST)

Join Genpact’s leading regulatory affairs expert, Kyle Fliszar, as he shares the experiences of regulatory teams who have used Genpact’s MAST solution to manage submissions data in a single, integrated platform to allow input and visibility across functions to minimize discards, gaps in product supply, and non-compliance.

Learning objectives
During this session we will explore the relationship between regulatory, quality, and manufacturing to manage and support submissions. You will learn how to:
• Reduce downstream supply constraints that impact the regulatory strategy for submissions
• Minimize risk and delays through meticulous execution planning   
• Mitigate direct risk to revenue with effective submissions management and governance

Suitable for
Regulatory Affairs teams of all levels
• Supply Chain teams of all levels
• Quality teams that support batch release


 Kyle Fliszar, Vice President, Genpact  

Kyle is a life sciences professional with over 20 years of experience working in the pharmaceutical industry holding roles across a range of functions including analytical research, regulatory affairs, manufacturing, and commercial. 

Kyle spent 20 years at Merck where he worked across various domains and therapeutic areas. Ultimately, he became Head of Regulatory Affairs and Clinical Safety Business Development responsible for overseeing all aspects of incoming and outgoing partnerships as they related to regulatory affairs and clinical safety.  In the final few years of his tenure, he played a critical role in designing the R&D organization for Organon and led the internal team responsible for transfer of >4500 marketing authorizations from Merck to Organon. 

Kyle has an undergraduate degree in Chemistry from Villanova University, and a MS & PHD in Pharmaceutical Chemistry from Lehigh University. He recently completed the Regulatory Excellence Leadership Academy through McKinsey and held the position of Adjunct Professor of Chemistry at Lehigh University for 10 years.

Kyle has spent a large portion of his career managing international teams comprised of internal employees and external partners across many domains giving him excellent breadth in the industry.

This webinar is sponsored by Genpact.

Disclaimer: Whilst TOPRA is running this webinar for Genpact, this is not an endorsement of Genpact, Genpact's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

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  • Members: free
  • Non-members: free

Terms and Conditions

By purchasing this webinar, you are agreeing to TOPRA's training terms and conditions.


27/10/2021 14:00 - 15:00
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