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Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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
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.
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.
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:
Regulatory Information Management (RIM)
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.