Importance of Critical Thinking in Regulatory Intelligence (On-demand)
This is an on-demand recording from July 2023
Critical thinking is an evidence-based process of actively and skillfully conceptualizing, applying, synthesizing, and evaluating information to reach a conclusion. Regulatory intelligence requires monitoring and analyzing evidence-based data, separating fact from inference. It is an area where critical thinking helps regulatory professionals solve problems and make decisions based on industry trends, while they gather and analyze data.
In this webcast, attendees will learn strategies to help them think critically, including reading for understanding, examining arguments, clarifying thinking, and cultivating “habits of mind.
REGISTRATION FEES & DEADLINES
Member: Free | Nonmember: $25
Learning Objectives
At the conclusion of this workshop, participants should:
- Define critical thinking
- Describe the importance of thinking critically to make effective strategies for questions raised in drug development projects
- Describe how critical thinking skills can be used to evaluate information and decision making for regulatory intelligence
Audience Learning Level:
q 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.
Who Should Attend?
Regulatory professionals, specialists, managers, associate directors, and directors/p>
Instructors:
Ana Sengupta, senior manager in regulatory affairs—CMC at AbbVie has more than 24 years of professional experience in the biotechnology and the pharmaceutical industry, with 12 years of direct experience working in regulatory affairs. Prior to joining AbbVie, she worked in various capacities in research and development area of drugs and biologics in mid-size to large, multi-national pharma/biotech firms such as Novartis, Genentech, and AstraZeneca. She has experience in regulatory requirements for early and late stages of drug development for both small molecules (New Chemical Entity) and large biomolecules (New Biologic Entity), indicated for several therapeutic areas such as oncology, hematology, cardiovascular, neuroscience, etc. She has regulatory filing and product approval experience in the US as well as global markets. She has experience in lifecycle management of drug products, assessing and evaluating changes, authoring, and reviewing of IND, IMPD, NDA and BLA. She is passionate about bringing safe and effective drugs to patients.
She has a master’s degree in chemistry from the University of Nebraska-Lincoln and an MBA in healthcare management from the University of California, Irvine. She also has a MSc. degree in microbiology from India. She has also earned a project management certificate from the University of California, Berkeley, a regulatory affairs certificate from University of California, Santa Cruz, and earned her RAC-US in 2018. She is also a volunteer chapter leader for the RAPS San Francisco Bay Area Chapter.
