The COVID-19 Impact: How will Regulatory Emerge from the Pandemic? (On-Demand)

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The COVID-19 Impact: How will Regulatory Emerge from the Pandemic? (On-Demand)

This is an On-demand recording from December 2020. 

COVID-19 has had a tremendous impact on the Life Sciences industry and forced companies to reassess their organizational resiliency and agility. Register for this webcast to learn how regulatory teams are adapting to this global health crisis and what effects it will have in the short and long term.

Experts from the Gens & Associates fall COVID-19 pulse survey will focus on implications for regulatory activities, business operations, and the future regulatory workforce. Scott Cleve, VP of Regulatory Operations at bluebird bio, will also share insights into how COVID-19 is prompting cultural and technological changes at his organization and what he projects for the broader regulatory industry.


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 the impact of the global health crisis to regulatory teams through the latest primary research

·        Be able to consider how your organization compares to others in the industry and what best practices you can leverage going into 2021

·        Have learned how one innovative biotech is proactively adapting to thrive in a post-COVID world


Who Should Attend:

·        Life sciences leaders (manager, director, and VP-level) in the following areas:

o   Regulatory Operations

o   Regulatory Affairs

o   Regulatory Information Management (RIM)

o   Submissions & Document Management



Steve Gens (MSOD), Gens and Associates Inc.

Managing partner of Gens and Associates Inc., Steve has more than 30 years of business experience, mostly in the biopharmaceutical and healthcare industries. Gens and Associates Inc. is a global healthcare consulting firm specializing in strategic planning, regulatory information management, industry benchmarking, and organization development. Steve and his team consult for many large and small global life science companies and are well known for their extensively used industry surveys.


Katherine Yang-Iott, Gens and Associates Inc.

As consultant and analyst, Katherine is a core member of the Gens and Associates team with more than 15 years of experience in the healthcare and pharmaceutical industries. Prior to joining Gens, she worked as a research scientist at Regeneron Pharmaceuticals and The Children’s Hospital of Philadelphia where she focused on strategy development and continuous improvement projects to support research operations.


Scott Cleve, Bluebird Bio

As vice president of regulatory operations & compliance, Scott leads the Regulatory Operations and Compliance team at bluebird bio. In past roles, Scott built and led publishing and regulatory operations teams at Astellas, AbbVie, and Boehringer Ingelheim. While many of his roles have been technical in nature, Scott is inspired to build high-performing teams and help people develop and meet their career goals. He seeks to build efficient, easy-to-use processes and systems and enjoys exploring the latest trends in technology including AI, ML, and automation.


Rachel Belani, Veeva Systems

As director of strategy for Vault RIM at Veeva Systems, Rachel serves as a key member of the global regulatory strategy team, supporting enterprise and key SMB (small-to-medium) life science customers. She contributes to product strategy, customer enablement, sales approach, and marketing efforts for the Veeva Vault RIM Suite.

Prior to Veeva, Rachel spent 13 years developing solutions and processes within and for life sciences organizations, with a specific focus on regulatory, clinical and safety.

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