2023 CDISC 한국 인터체인지 등록이 오픈되었습니다. 한국에서 처음으로 열리는 CDISC 컨퍼런스 행사로써, 의학 연구 분야에서 전세계적으로 사용되는 데이터 인터체인지 표준에 대한 깊은 이해와 공유의 장이 될 것입니다.

1. 메인 컨퍼런스

• 일시: 2023년 12월 13일 - 14일

• 장소: The K Hotel 서울

• 내용: 데이터 인터체인지 표준에 관한 최신 동향, 전략적 아이디어 및 구현 경험 공유

2. 교육 과정

• 일시: 2023년 12월 11일 - 12일

• 장소: KoNECT

• 내용: CDISC 표준에 대한 심층 교육 및 실습

등록 방법 및 유의사항

• 교육 과정(12월 11-12일)의 등록은 메인 컨퍼런스와 별개로 이루어집니다.

• 교육 과정 등록을 원하시는 분은 CDISC Learn Store를 방문하여 등록하시기 바랍니다.

Register 등록 및 자세한 내용은 본 링크를 통해 페이지 이동이 가능합니다.

Seoul, Korea In-Person Training Event (Open to the Public)

11-12 December 2023

Location:

KoNECT

6th floor of the 137 KPX Building, Mapo-daero, Mapo-gu, Seoul, Republic of Korea

Trainings:

• ADaM Core Theory & Application (1-day training):

  Mon, 11 December 2023 - 09:00-18:00 CET

  
  

• SDTM Theory & Application (2-day training):

  Mon, 11 December 2023 - 09:00-18:00 CET;

  Tues, 12 December 2023 - 09:00-18:00 CET

  
  

• CDASH Fundamentals (1-day training):

  Tues, 12 December 2023 - 09:00-18:00 CET

  
  

• Define-XML (1-day training):

  Tues, 12 December 2023 - 09:00-18:00 CET

Format:

In-person (no virtual option); please bring a laptop to fully participate in the training

Training Materials:

After successful enrollment, please check your email; you will receive access to the online training materials within the CDISC learning management system.

Language:

Trainings will be taught in English using English materials.

Questions?

CDISC 페이지 참조 (https://learnstore.cdisc.org/catalog?pagename=1689172892K5viJ)

2023 Korea Interchange

The 2023 CDISC Korea Interchange is an event consisting of workshops, training courses, and a two-day Main Conference. CDISC Interchanges are held annually on three continents with hundreds of attendees gathering to share their expertise, best practices, and lessons learned in developing and implementing CDISC standards to bring clarity to data.

Education Courses | 11-12 December 2023

Main Conference | 13-14 December 2023

Membership Discounts: CDISC Platinum Members receive a 40% discount, and CDISC Gold Members receive a 20% discount off of Main Conference registration and Education Courses!

Find out if you are a CDISC Member here.

Group Discounts: Discounts are available for groups of 10+ people from the same organization. Contact events@cdisc.org for details.

Early Bird Discounts: Register early to receive the lowest rates for the conference.

Save the Date

Save December 11-14 2023 in your calendars! Questions? Contact the CDISC Events team by clicking the button below.

Contact Us

Call for Abstracts Now Open

The call for abstracts is now open! Submit an abstract for consideration by Friday, March 10th 2023 for review by our program committee.

Submit an Abstract

Sponsor & Exhibitor Opportunities

Elevate your conference experience by sponsoring or exhibiting during the event! Space is limited.

Become A Sponsor

Why Attend an Interchange?

See seven good reasons you should attend!

Reasons

자세한 내용은 아래 출처를 클릭하세요.

Sponsorship and Exhibitor opportunities are available for our 2023 Korea Interchange.

Please fill out the form below with your contact information and then select your preferred sponsorship or exhibitor package.

Please make sure to click the "Submit Form" button once complete. You will then receive an electronic invoice from CDISC within five business days.

*Flyer to be provided by Sponsor.

**Diamond and Ruby Sponsors will be provided with a list of attendees who have opted-in to Sponsor Marketing when registering for the Interchange.

Bundle your sponsorship for up to three (3) CDISC events, at a significantly reduced rate (20% discount for 3 events; 10% discount for 2 events). When a sponsor chooses to bundle three events, they become a Global Sponsor, which guarantees all of the benefits of the package level they select, for all three events.

Global Diamond Sponsor is an exclusive sponsorship level, limited to only one (1) per year.

Prices shown are for 2023 Korea Interchange only

자세한 내용은 아래 출처를 클릭하세요.

2023 Korea Interchange Call for Abstracts

Abstracts Due: Friday, 25 August 2023

We welcome abstracts for the 2023 CDISC Korea Interchange on any of the topics listed below.

Novelty in Clinical Trials and CDISC Standards

• How modernization of clinical trials is impacting CDISC standards: experience from decentralized trials, master protocols, etc.

• Social evolution can impact clinical trials conduct and standards: share experience or initiative related to this (e.g. diversity inclusion)

Real World Data / Evidence

• The life cycle of drug development is being modernized through the use of real-world data / evidence.

  • The combination of RCT data (safety, efficacy) and RWD (effectiveness) for submission is becoming the 'new' standard

• We are interested to receive experiences from the industry on the following related topics:

  • Sports Medicine study like ACSM + CDISC

  • Digital Medicine studies

  • Progress and barriers to the use of real-world data / evidence for regulatory evaluation

  • Best Practices of using CDISC Standards for RWD and Barriers

  • Pragmatic Clinical Trials

  • Use of CDISC and other life sciences/healthcare standards (OMOP data model, HL7 FHIR, etc.)

    • FHIR to CDISC Joint Mapping Implementation Guide v1.0

  • CDISC collaborations with other standards and initiatives

  • Move to decentralized clinical trials - usage of digital biomarkers / digital endpoints (collected as part of the clinical trial)

CDISC in Academic Research

• Healthcare Data Systems

• eSource/Direct Data Capture (DDC)

• Meta Analysis / Data Integration

• Computer Science and Data Science perspectives on CDISC standards

Conformance Rules and Validation, Including CDISC Open Rules Engine (CORE)

• Implementation of FDA / PMDA Business / Validation rules vs. CDISC conformance rules

• Experience of various validation tools for SEND / SDTM / ADaM / Define-XML

• Rules coming as part of a TAUG

• Conformance rules integration into the standard governance

• Experience in use of Open Source tools

• Experience in the use of CORE, Rules Authoring Tool and generation of Rules

Global Regulatory Submissions

• Submission to FDA / PMDA / NMPA learnings

• Submitting around the globe, submission experience with other Health Authorities e.g. EMA Clinical Trials Raw Data Pilot

• Supporting FDA BIMO deliverables

• Achieving quality and efficiency in data submission e.g.

  • Proper documentation

  • How to correctly provide metadata in Define-XML

  • Automation

  • Process flow

• Impact of new FDA guidance e.g.

  • Standard Safety Tables and Figures Guide

  • Experience and adherence to FDA division guidance e.g., CBER Vaccine, CDER NASH, etc.

  • Inclusion and diversity requirements and challenges from a standards point of view, e. g. gender, how to correctly provide metadata in Define-XML

  • RWE impacts decision making by regulators – opportunities and challenges from data standards / harmonization / review

Standards Governance, MDR and CDISC 360 - User Experiences

• How to handle CDISC versions before submission / across standards / regulatory agency requirements

• How do you handle non-adherence in terms of submission to one or multiple regulatory agencies, how do you ensure adherence?

• Metadata-driven governance. Collected element usage. How do you determine what data you aren’t using in the final CSR, in order to simplify collection?

• Graph databases / linked data implementations

• Automation experiences

• Implementation of USDM / Transcelerate DDF

CDISC Foundational Standards

• CDASHIG 2.3/3.0

• SDTM/IG 2.1/4.0

  • SDTM/IG 1.7/3.3 Upversioning Experience

• ADAM

  • ADaM Metadata Submission Guidelines 1.0

  • ADaM popPK Implementation Guide 1.0

  • Analysis Results Standard v1.0

  • Advanced use cases

• SEND/IG 2.1/3.2

• Define-XML v2.1

• TAUG

OTHER TOPICS TOWARDS CDISC STANDARDS

You are welcome to submit an abstract on any CDISC model experience, its implementation and associated planning. Related use cases are encouraged. We want to hear your success stories even if they do not fit into the topic areas mentioned. CDISC is an open and multidisciplinary standard which interfaces with many areas and we are eager to hear about your experiences working with standards.

자세한 내용은 아래 출처를 클릭하세요.

2023 CDISC PUBLIC TRAINING COURSE 강의실 안내드립니다.

202.022~07 ~ 2023.02.09 3일간 동국대학교 서울캠퍼스 내 학림관 강의실에서 진행됩니다.

• Newcomers : Class A (학림관 J211 )

  • 2월 7일 화 14:00~17:00

• SDTM : Class A (학림관 J211 )

  • 2월 8일 수 09:00~18:00

  • 2월 9일 목 09:00~18:00

• SEND : Class B (학림관 J212 )

  • 2월 8일 수 09:00~18:00

  • 2월 9일 목 09:00~18:00

감사합니다.

2023 CDISC 공식 교육 과정 바우처 코드 제공

2월 8일~9일 운영되는 CDISC Public Training Course SDTM 과정 및 SEND 교육과정의 50% 할인 바우처 코드를 제공합니다.

2월 5일까지 적용가능한 바우처 코드로 등록시 해당 코드를 입력하여 수강신청 바랍니다.

- SDTM Training : New Discount Code: sdtm_korea_training_2023

- SEND Training : New Discount Code: send_korea_training_2023

CDISC Public Training Course

Hosted by CLUPEA, organized by Korean CDISC Coordinating Committee (K3C)

2023. 2.7. ~ 2023. 2.9. (3일간)

동국대학교 서울캠퍼스 내 강의실

| 교육 일정

• 전 교육과정은 CDISC Training Course 운영지침을 준수하여 진행

• CDISC for Newcomers 과정은 한국어 교육으로 진행

• SDTM Theory and Application, SEND Implementation 과정은 별도 통번역 없이 영어로 진행

• SDTM Theory and Application, SEND Implementation 과정은 노트북 지참 참석 권장

• 점심식사, 주차 별도 지원 없음

| 과정 개요

CDISC for Newcomers : CDISC란 무엇인가? 에서부터 CDISC의 필요성, 데이터 교환 표준 등 CDISC 전반에 대한 설명과 이해를 높이기 위한 입문자를 위한 기초 교육 과정입니다.

SDTM Theory and Application : SDTM(StudyDataTabulationModel)은 상호 운용 가능하고 재사용 가능한 데이터 공유를 지원하기 위해 전임상 및 임상데이터를 구조화하기 위한 규격으로, 미국FDA 및 일본 PMDA에 제출 가능한 데이터 형식입니다.

이 과정은 SDTMv1.7 및 SDTMIG v3.3의 표준 문서에 있는 정보를 대략적으로 다룹니다.

SEND Implementation : SEND는 CDISC 표준 비임상 데이터 교환 구현 가이드로 단일 및 반복 투여 독성 시험의 데이터 제출을 위한 데이터 작성 모델을 제공합니다.

이 과정은 SEND 표준 구현을 진행할 연구원(데이터 준비 및 데이터셋 구성 등)을 위한 교육 과정이며 데이터의 구조를 확인할 수 있어 SEND 데이터를 검토하는데 유용한 정보를 제공합니다.

CDISC Public Training in Seoul, South Korea 일정 공지입니다.

한국 CDISC PUBLIC TRAINING을 개최합니다.

장소는 동국대학교 서울캠퍼스이며,

2023년 2월 7일부터 9일에 개최합니다.

신청은 아래 링크로 신청 하실 수 있습니다.

CDISC for Newcomers:

https://learnstore.cdisc.org/product?catalog=CDISC-for-Newcomers

SDTM Theory and Application:

https://learnstore.cdisc.org/product?catalog=SDTMTAHCTED2

SEND Implementation:

https://learnstore.cdisc.org/product?catalog=SEND-Implementation

문의 사항은 클루피 contact us로 문의 주십시오.

감사합니다.

CDISC 2023 한국 인터체인지가 확정되었습니다.

개최일자는 2023년 12월 11~14일 서울에서 열립니다.

CDISC 2023 한국 인터체인지의 향후 일정에 대해서 새로운 소식이 있으면 바로 업데이트 하도록 하겠습니다.

많은 관심 부탁드리며 문의 사항은 Contact us 혹은 contact@clupea.co.kr 로 연락바랍니다.

감사합니다.

The 2023 CDISC Korea Interchange is an event consisting of workshops, training courses, and a two-day Main Conference.

This event will provide an opportunity to share progress, implementation experiences, and strategic ideas on world wide data interchange standards for medical research.

Main Conference | 11-14 December 2023

please Contact us Click!