Loading…
← Back to schedule
#630: Streamlining Regulatory Frameworks for Complex Generic Development: Global Extractables and Leachables Harmonization
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
112AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-620-L04-P; CME 1.00; RN 1.00

Examine evolving extractables and leachables (E&L) regulatory guidance focusing on ICH harmonization efforts to support complex generic development through aligned risk management approaches and streamlined global regulatory frameworks.

Learning Objectives

Evaluate current global regulatory frameworks for E&L assessment in complex generic products; Analyze risk-based approaches for leachable impurity control across different jurisdictions; Synthesize harmonization opportunities to streamline product development and regulatory submissions.

Chair

Allison Radwick

Speaker

Panelist
Chaitanya Koduri, DDS, MHS

Panelist
Karthik Balasubramanian, PHD, MS

Panelist
James Wabby, MHS

Panelist
Ji Guo, PHD


Speakers
avatar for Karthik Balasubramanian

Karthik Balasubramanian

Dir Project/Program Management, External Manufacturing, Teva Pharmaceuticals, United States
Dr. Karthik Balasubramanian, Ph.D is Director, Program and Project Management at Teva Pharmaceuticals. He has over 20 years of experience in all phases of medical device and combination product development, from R&D to Technical Operations. Prior to joining Teva, he has worked in... Read More →
JG

Ji Guo

Chemist, OPQ, CDER, FDA, United States
Dr. Ji Guo is a chemist in the Office of Policy for Pharmaceutical Quality (OPPQ) within the Office of Pharmaceutical Quality (OPQ) at the FDA's Center for Drug Evaluation and Research (CDER). Her work encompasses scientific review of drug quality issues, policy analysis, and collaboration... Read More →
avatar for Chaitanya Koduri

Chaitanya Koduri

Director, International Government and Regulatory Engagement, US Pharmacopeia, United States
Dr. Chaitanya Koduri serves as the Director of International Government and Regulatory Engagement in the Global External Affairs division of the United States Pharmacopeia. In this capacity, Dr. Koduri oversees international regulatory partnerships involving the United States Pharmacopeia... Read More →
AR

Allison Radwick

Senior Regulatory and Policy Communications Manager, U.S. Pharmacopeia, United States
Allison is accomplished in combining communications, regulatory affairs, policy and science with demonstrated success driving public engagement initiatives, implementing integrated outreach plans and liaising across executive and functional levels. Skills include building awareness... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

Tweet Share

Get help with the event

Contact event planner Event login
View support guides Find upcoming events
Create an event you'd love to attend!
Explore why organizers choose Sched • Success stories
Event App • Event scheduling • Event registration • Event ticketing • Sched forms • Call for papers • Badges • Conferences
© 2026. SCHED LLC - All rights reserved - Helping events since 2008
Meeting Planning Software • Privacy • Terms
Share Modal

Share this link via

Or copy link