South Korea: Navigating the Clinical Trial and Regulatory Environment is a webinar that focus on regulations and compliance issues culturally handled in Japan.
Topics
- Conducting Clinical Studies in South Korea
Likely Parameters Defining Clinical Trials, South Korea`s Clinical Investigational Plan (CIP), Importing the IMP & Supplies into South Korea, Clinical Trial Start-Up, Finding & Hiring CROs in South Korea, Product Labeling Requirements, Priority Reviews in South Korea, Conducting Clinical Trials in South Korea, CT Close-out and Reporting Requirements, Clinical Trial Pharmacovigilance Reporting, Effectively Working with the Regulators and Cultural Aspects – Working in South Korea - South Korea Regulatory Compliance
South Korea`s Regulatory Agencies Structure and Responsibilities, Overview of South Korea`s Healthcare System, Agency Review Process for Decision-Making, South Korean Drug Development Process, South Korea and ICH (International Conference on Harmonization), Country Establishment Licensing & Procedures – Requirements for Conducting Clinical Research, South Korea`s Desire for Innovative Products, Requirements for Clinical Trials in South Korea, The Changing KFDA, How South Korea Wants to be Involved in Clinical Trials?, Korean Philosophy in Risk Evaluation, Conducting Meetings with the Agency, Amending the CTA and How to Apply for Clinical Trials in South Korea
Who should Attend
Regulatory Affairs Professionals, Clinical Trial/ Research Professionals, Manufacturing/ Production, QA/ QC, Senior Management and Global Business Development.
