Question from: inah choi inahchoi@lgchem.com at 2026-01-21 23:39:04

Dear Melissa Brod
I hope this message finds you well. I am evaluating the suitability of your program for our team and would appreciate your clarification on the points below.
By way of introduction, I work as an Investigational Product Manager responsible for clinical trial medication management. While we frequently outsource global shipment and supply management to CROs and logistics partners, I am considering this course to strengthen our in‑house capability for cases where we do not outsource these activities. I believe sharing this context will help you advise on the program’s fit.

1.Case Studies – Clinical vs. Commercial Focus
Does the bootcamp include case studies on international shipping and customs clearance for clinical trial materials (Inecstigational Product)? If so, could you indicate the approximate balance between clinical and commercial scenarios (e.g., 60:40)?

2.Importer of Record (IOR) in Clinical Settings
Will the course cover how to establish and document the Importer of Record (IOR) during the clinical phase, including responsibility delineation between the sponsor and vendors (e.g., CRO, logistics providers)? If available, we would also be interested in actual inspection observations/findings related to IOR.

2. Temperature Control & Documentation Consistency
Does the curriculum address temperature monitoring and excursion management, alongside documentation consistency among regulatory and shipping documents (e.g., Label, Commercial/Proforma Invoice, Import Permit, Chain of Custody/CoC)—specifically from an inspection readiness perspective?

3. Vendor Oversight Best Practices (Depot/3PL)
Is there a session that shares best practices for vendor oversight of depots and 3PLs, including expectations and examples for QTA, SLA, Deviation handling, and CAPA management?

4. VAT Applicability & Exemption Processes for IPs
Does the program cover country‑specific VAT applicability for clinical trial materials (IPs) and the pre‑approval or exemption application processes (e.g., required documents, authorities involved, typical timelines, and common pitfalls) to obtain VAT relief where available?
In addition, could you please share the detailed agenda—including session titles, subtopics/modules, learning objectives, and timing (duration per session)—so that we can better assess the program’s depth and applicability to our current needs?
Thank you very much for your time and support. I look forward to your response.