This workshop is designed for regulatory professionals who want to develop their critical thinking skills and learn how to apply regulatory intelligence for optimizing approaches to drug development.
Regulatory intelligence is the process of gathering, monitoring, and critically evaluating evidence-based data and industry trends to inform strategic regulatory actions and make effective drug development decisions. Regulatory intelligence professionals leverage artificial intelligence (AI) resources to accelerate the overarching regulatory impact and risk analysis throughout the drug development lifecycle.
This workshop will introduce the fundamental requirements to implement regulatory intelligence in a medicinal product development organization and help members of the department develop the ability to think critically. Attendees will learn how to apply AI to develop science-based and risk-based regulatory strategies for development and lifecycle management of medicinal products.
Case study examples will leverage participants’ analysis skills to obtain data-driven regulatory insights. A human-centric approach will guide the technical aspects of using AI for data acquisition, validation, model development, performance assessment, interpretability, and model deployment. Workshop attendees will develop their ability to separate fact from inference when it comes to regulatory intelligence.
Registration Fees & Deadlines
12 July 2024 – 03 September 2024: Member $825 | Nonmember $970
04 September 2024 - 04 October 2024: Member $970 | Nonmember $1150
Learning Objectives
- Upon completion of this session, participants will be able to develop fundamental critical thinking skills, including how to read for understanding, examine arguments, clarify thinking, and cultivate "habits of mind."
- Upon completion of this session, participants will be able to learn how to use artificial intelligence for regulatory intelligence including data acquisition, validation, model development, performance assessment, and interpretability.
- Upon completion of this session, participants will be able to learn how to identify and evaluate evidence, and how to distinguish between facts and inferences.
Who Should Attend?
Regulatory Intelligence, Regulatory Strategy, Regulatory Affairs
Audience Learning Level
Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.
Speakers
Ana Sengupta
Regulatory Affairs CMC, AbbVie Inc.
Susan Carino
Principal Regulatory Consultant,
Integrated Project Management Company, Inc.
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org