Name: Implementing FDA’s IVPT Recommendations: A Step-By-Step Illustration
Start: 2025-04-29T08:30:00-04:00
End: 2025-04-30T15:30:00-04:00
Location: The Universities at Shady Grove

$Implementing FDA\u2019s IVPT Recommendations: A Step-By-Step Illustration$

Critical considerations to guide investigators during method development, validation, and study conduct will be discussed at each stage.
About this Event

Registration Fees:

$350, in-person attendees - general

$150, in-person attendees - government (must have an email ending in ".gov" in order to register at this rate)

For in-person attendees, beverages and food for breaks will be provided; lunch is not included. A link will be provided closer to the event for ordering lunch each day.

Free, virtual attendees

For faculty and students from the University of Maryland, Baltimore; The Universities at Shady Grove; and University of Michigan, the workshop is free for in-person attendance. Other students, please email us for a reduced rate. Please contact us at ([email protected]) and indicate which workshop you are interested in.

The workshop will clarify the intent of FDA recommendations for IVPT studies, with step-by-step demonstrations illustrating how IVPT study procedures can be performed in a manner compatible with recommendations in FDA’s Guidance for Industry: In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs. The focus will be on IVPT method procedures that abbreviated new drug application (ANDA) applicants frequently struggle to implement successfully, and the procedures will be demonstrated using different IVPT diffusion cell systems from major manufacturers. Critical considerations to guide investigators during method development, validation, and study conduct will be discussed at each stage. Also, best practices for dealing with issues that arise in different scenarios will be discussed.

Join us in person for an interactive experience featuring hands-on activities with diffusion cell systems from different manufacturers to discuss how different design features could impact how you implement FDA Guidance recommendations. Small group working sessions (only for in-person attendees) will simulate challenges and illustrate how one should navigate decisions during IVPT method development and study design for a hypothetical topical drug product. In person attendees will also have the chance to engage with regulatory, academic, and industry experts to ask questions, learn practical skills, share knowledge, and discuss how to approach challenges you may have experienced with IVPT studies. Virtual attendees will enjoy the convenience of accessing live presentations and panel sessions that discuss procedures illustrated with pre-recorded demonstrations.

Agenda
Day 1 Session 1: Current status and challenges with IVPT studies

Info: Session 1: Current status and challenges with IVPT studies
Format: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees)
• In this session, regulatory and industry scientists will discuss current challenges with the design, conduct, analysis and assessment of IVPT studies as a component of a characterization-based bioequivalence approach.

Day 1 Session 2: How to develop an IVPT method

Info: Session 2: How to develop an IVPT method – Theoretical understanding and hands on demonstrations
Format: Presentations, Illustrative videos, and a Panel Discussion with Q&A (Virtual and In-Person Attendees)
• This session will include presentations from FDA laboratories on their approach to IVPT method development, along with recorded demonstrations of suitable IVPT study procedures, and common pitfalls to avoid during IVPT method development, using different diffusion cell equipment from multiple manufacturers.

Day 1 Session 3: In-Person activities

Info: Session 3: In-Person Activities
Format: Small Group Working Sessions (In-Person Attendees Only)
• Small group working sessions will work through hypothetical scenarios that provide attendees the opportunity for more in-depth discussion and collaboration with experts on IVPT method development, validation and data analysis.

Day 2 Session 1: Considerations related to the analysis of IVPT data

Info: Session 1: Considerations related to the analysis of IVPT data
Format: Presentations and a Panel Discussion with Q&A (Virtual and In-Person Attendees)
• This session will include presentations from FDA on the scientific and regulatory considerations for analysis of IVPT method validation and pivotal study data.

Day 2 Session 2: Holistic Panel Discussion

Info: Session 2: Holistic Panel Discussion
Format: Panel Discussion with Q&A (Virtual and In-Person Attendees)
• Following the presentations across both Day 1 and 2, this discussion will cover the lessons learned, along with identifying the areas that are most needed to address the ongoing challenges with IVPT, where the FDA can provide additional guidance.

Day 2 Session 3: In-Person Activities (Continued from Day 1)

Info: Session 3: In-Person Activities (Continued from Day 1)
Format: Small Group Working Sessions (In-Person Attendees Only)
• Small group working sessions will work through hypothetical scenarios that provide attendees the opportunity for more in-depth discussion and collaboration with experts on IVPT method development, validation and data analysis.