GCSG 2024 Asia Pac Seoul Boot Camp: Program

Day 1 : Wednesday, February 28

9:00 am - 4:30 pm
Boot Camp / Seminar

Import and Export of Clinical Supplies - An Overview

This session is designed for those who want to learn more about the fundamentals of international logistics as well as best practices when planning and executing global clinical trials.

Delivered by clinical supply professionals with real life experience, various topics related to the distribution of clinical supplies will be covered, including:

●      Commodity Codes
●      Incoterms
●      Trade compliance, with a focus on the US, Europe, China, Singapore and Australia
●      Import Tax / Value Added Tax (VAT)
●      Role of the Qualified Person (QP) in the EU
●      Supply chain strategies (in-country depot vs direct to site)

Speakers:

9:00 am - 4:30 pm
Boot Camp / Seminar

Understanding the Essentials of the Clinical Supply Chain

This intensive session will focus on drug development and what goes into planning for and delivering a study drug for a clinical trial.

Learn the fundamentals of the clinical supply chain via theory and real-life case study examples, setting you up for success in this industry.

Topics will include:
●      Reasons behind Good Manufacturing Practices (cGMPs)
●      Phases of new drug development and approval
●      Randomizing and blinding clinical trial materials
●      Quality assurance and documentation
●      Protocol interpretation
●      Patient compliance
●      Labeling
●      Standard operating procedures (SOPs)
●      Stability
●      Good Distribution Practices (GDPs)
●      Returned drug accountability
●      Changing regulations in the European Union (EU) and rest of world (ROW)

Speakers:

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