Back to: FDA-CRCG Mastering Particle Size Analysis Workshop
Presentations
Unresolved Challenges in Determining API Particle Size Distribution in Complex Suspensions Using Laser Diffraction
Jernej Grmaš, PhD
Head of Physical Analytics, Lek Pharmaceuticals d.d. (Sandoz)
Challenges in DLS-Based Method Development: The Issue of Heterogeneity
Rama Subba Reddy K, MS
Analytical Expert-ACT Lab-Polymorphism & Nanosizing, Dr. Reddy’s Lab. Ltd
Bridging the Gap Harmonizing Laser Diffraction PSD with Real-Life Results and Regulatory Requirements
Yousif Ayoub, PhD
Director, Head of Analytical Development, KFS R&D, Teva Pharmaceuticals, Inc.
Hurdles/Issues/Challenges with Regulatory Package for Submission-Generic Industry Perspective
Bernard Domnic, MS
Director, Regulatory Affairs, Teva Pharmaceuticals, Inc
About
Industry leaders will share their experiences and insights on the challenges faced in developing generic products, with a focus on particle size measurement. Speakers will discuss critical aspects such as technology selection, method development, and validation processes. The session will also explore the emerging role of artificial intelligence and machine learning in knowledge management for regulatory submissions. A key component of this session will be a discussion on potential hurdles in preparing submission packages and areas where additional FDA guidance could be beneficial, fostering a productive dialogue between industry and regulatory perspectives later in the workshop.