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Virtual

Jun 09, 2026 9:30 AM - Jun 09, 2026 12:30 PM

Extractables and Leachables Harmonization: Risk-Based Approaches for Complex Generic Development

This is a virtual pre-meeting Short Course in conjunction with the DIA Global Annual Meeting.

Instructors

Ravi Kiran  Kaja, PHD

Ravi Kiran Kaja, PHD

Senior Principal Scientist, Complex Generics, Pharmaceutical Science, The United States Pharmacopeia (USP), United States

Dr. Ravi Kiran Kaja, Ph.D., FRSC, is a senior scientific leader with 20+ years of experience in analytical chemistry and pharmaceutical R&D, specializing in sterile and complex drug products. At USP, he leads scientific strategy for complex generics and develops high impact USP–NF standards that strengthen global quality and regulatory frameworks. His expertise spans formulation analytics, E&L, and technology transfer. A collaborative leader and mentor, Dr. Kaja is dedicated to advancing pharmaceutical quality and supporting the next generation of scientists.

Rodrigo  Feliciano, PHARMD, PHD

Rodrigo Feliciano, PHARMD, PHD

Senior Principal Scientist, Johnson & Johnson Innovative Medicine, Belgium

Rodrigo Feliciano is a Senior Principal Scientist at Johnson & Johnson, Belgium, and an E&L subject matter expert supporting regulatory strategies for complex drug–device combination products. He has 20 years of experience in analytical chemistry, including nine years focused on E&L, with expertise in chromatography and mass spectrometry. He holds a PharmD from the University of Lisbon and a PhD from the University of Wisconsin–Madison, followed by postdoctoral training in Germany. He has authored 33 peer-reviewed publications, is an active member of the ELSIE community, represents Belgium in ISO/TC 194, and is a Fulbright alumnus.

Alicja  Sobantka, PHD

Alicja Sobantka, PHD

Group Director Corporate Material Qualification, Octapharma, Austria

Chemical engineer with PhD (2013) in resource management and water quality; work experience in composite materials, dairy processing, blood plasma- and cell derived therapeutic proteins, and REACH regulation. Managing E&L at Octapharma since 2015.

Wim  Van Rossom

Wim Van Rossom

Senior Material Safety Expert, Associate Director, UCB BioPharma, Belgium

Wim Van Rossom is Extractables & Leachables (E&L) Expert at UCB, ensuring product quality and patient safety and application of the current legislation. Wim represents the PhRMA consortium as Quality Topic Lead in the ICH Q3E expert working group establishing the ICH guideline for E&L and he is active within the ELSIE (Extractables & Leachables Safety Information Exchange), BioPhorum and PhRMA consortia. Prior to joining UCB, he held a position at J&J where he provided leadership and expertise as E&L Subject Matter Expert and he has been E&L Study Director at Nelson Labs Europe providing him with hands-on experience in setting up E&L studies as well as an excellent insight and understanding of the leaching behavior of materials.

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