Regulatory Policy and Intelligence: Understanding When, Why, and How to Invest in Growing These Capabilities
The COVID-19 pandemic has magnified the importance of regulatory policy and intelligence, a sometimes overlooked and perhaps undervalued division of the regulatory affairs department or organization. While it is easy to understand why these capabilities have come into the spotlight more recently, regulatory intelligence (RI) has increasingly proven to be a critical function as companies become more educated on the product-, portfolio-, and company-level impact it has on strategic development.
Upon 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
- 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. As a Managing Expert for YourEncore’s Regulatory Center of Excellence, 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, YourEncore
Anne Marie Finley is a subject matter expert in regulatory strategy for pharmaceutical and biotech organizations. She is currently Managing Expert for YourEncore’s 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.”