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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 October 2020.
Audience 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
conclusion of the program you will be able to:
Understand the fundamental requirements for performing an effective RI
assessment to determine gaps and opportunities for development
Articulate how RI activities, like trend spotting, and external environment
scanning will add value to the organization
Identify the appropriate RI strategy for your company based upon size,
portfolio and company objectives
Who Should Attend:
Associate Director, Director, VP of Regulatory Affairs
Brian E Harvey MD PhD, managing expert, Regulatory Center of Excellence, YourEncore
Brian E. Harvey, MD, PhD is a
physician and biochemist with academic research, clinical practice, U.S. FDA
regulatory, bio-pharmaceutical industry and non-profit experience. He currently
provides regulatory advice for biologics, drugs and medical device development
programs and volunteers as the Executive Vice President, Science and Regulatory
at the Global Liver Institute non-profit based in Washington, DC. Prior to his
current roles, Dr. Harvey held positions as Vice President of U.S. Regulatory
Strategy at Pfizer and Vice President of U.S. Regulatory Policy at Sanofi-Aventis.
Anne Marie Finley, MS, RAC, managing expert, Regulatory Center of Excellence,
Anne Marie Finley is a subject matter
expert in regulatory strategy for pharmaceutical and biotech organizations. She
is currently managing expert for YourEncore Regulatory Center of Excellence,
and was formerly Vice President, Government Relations & Public Policy at
Celgene. Anne Marie has developed robust regulatory solutions and provided
holistic perspectives for the entirety of her career and currently serves on
the Board of Directors of the FDA Alumni Association. She has been named to the
list of "Top 50 Global Thought-Leaders in Orphan Drugs and Rare
Diseases" by the World Orphan Drug Congress as "an expert with an
expert with access to different national regulators. Anne Marie has a unique
holistic perspective on the challenges surrounding orphan drug development
across multiple markets."