The In Vitro Permeation Test (IVPT) is an important performance test used by the generic drug industry to support demonstrations of bioequivalence for generic topical drug products, when utilizing efficient characterization-based bioequivalence approaches.
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.
Choose your experience:
Virtual Attendees will have free access to all sessions of the workshop except the small group (in-person) working sessions. Virtual attendees will be able to:
• Attend all presentations and panel discussions
• Participate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists
• Enjoy free access to workshop recordings of presentations and panel discussion (not including the small group working sessions)
In-person Attendees will enjoy all of the benefits of virtual attendance as well as interactive experiences featuring:
• Hands-on activities with diffusion cell systems from different manufacturers
• Small group working sessions simulating challenges and illustrating how one should navigate decisions during IVPT method development and study design for a hypothetical topical drug product
• Collaborative discussion and learning opportunities with FDA, academic, and industry experts
Workshop Topics
• Theoretical/conceptual understanding of the recommendations in the IVPT guidance
• Demonstration of step-by-step procedures using 4 different diffusion cell systems
• Critical considerations for method development, validation, and study conduct
• Expert guidance and best practices for overcoming challenges
Audience
This workshop is primarily designed for professionals within the pharmaceutical industry and associated contract research organizations that are involved with the design and conduct of IVPT studies. This includes pharmaceutical scientists, research and development specialists, quality assurance and quality control experts, regulatory affairs professionals and formulation and product development scientists.
• Virtual Attendance is optimal for an audience who would like to have access workshop content from anywhere, eliminate travel time and expenses, and who would like to have the flexibility to attend dynamic sessions/presentations at preferred times.
• In-Person Attendance is optimal for an audience that is interested in collaborative discussions and real-time engagement, immersive learning, interactive sessions and group activities.
Registration Fees:
• This workshop is FREE for virtual attendees.
• $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.
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 (info@complexgenerics.org) and indicate which workshop you are interested in.
