국가임상시험지원재단

● The Common Registry Data Packet: TransCelerate’s Initiative to Improve Data in Clinical Trial Registries / eLabels: Understanding the Benefits for Patients, Sites and sponsors

Keris Huang(MSD, TransCelerate representative )

TransCelerate BioPharma, Inc. is a unique collaboration of 19 global pharmaceutical companies, utilizing cross-industry perspectives to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high-quality delivery of new medicines through several initiatives. This session will provide an overview of two those initiatives.
? Develop technology assessment and proof of concept for regulatory and other stakeholder engagement.
? Clinical trial registries contain a high volume of scientific, jargon-rich data and information difficult for the lay audience, particularly patients, to search and interpret.
? The goal of this initiative is to develop a catalog of existing registry data submission fields, each with guidance on authorship and procedural best practices for clinical trial sponsors to ensure data quality
? The initiative is targeting its solutions towards the registry data submission fields patients find most useful and informative in clinical trial registries, as indicated by consultations with patients from a range of ages, conditions, and geographies.
Second, TransCelerate will provide an overview of its eLabels initiative:
An electronic label, or eLabel, is the provision of a complete investigational medicinal product (IMP) label on an electronic device while still utilizing a single panel label on the physical packaging. Because eLabels have the potential to realize several, significant benefits for patients, sites, regulatory bodies and sponsors, the TransCelerate eLabels Initiative was launched, helping the industry progress on the journey to digitally-supported, patient-centric clinical supply chains by facilitating regulatory engagement and promoting uptake of eLabeling across the industry. The TransCelerate eLabels Initiative aims to act as a catalyst for clinical supply chain transformation, enhanced patient utility, reduced clinical labeling timelines and costs, promotion of consistent, up-to-date information, and effective Health Authority engagement. The initiative’s main output is not an eLabeling system, specifications, or standard, but an eLabels Implementation Toolkit to facilitate external engagement and uptake in the industry. Specifically, the TransCelerate eLabels Initiative has worked to: ? Prepare an implementation toolkit to facilitate voluntary, modular adoption of eLabeling and to assist in Health Authority
engagement.
? Develop and implement an external engagement strategy including sites, patients and Health Authorities.
? Develop technology assessment and proof of concept for regulatory and other stakeholder engagement.?

● The Digital Patient Journey

Catherine Yi-San Lee(Pfizer)

While clinical trial landscape are continuing to evolve, pt centricity which means pts were empowered and encouraged to active participate in the trial journey and become one of the critical successful factor to weight in and secure the success of drug development. By leveraging new technology with innovative approach, we are going to share what’s our area of focus in Clinical Innovation in Pfizer, how we enhance our patient experience and engagement through mClinical pt journey and how we bring it together to prepare for 21st centry clinical trials with real case sharing. The case sharing will include our experience in eConsent deploying and another sharing regarding “Bring your own device” to improved diary compliance and reduced cost by using subject’s own smart phone for the capture of ePRO data.

1. Keris Huang(MSD, TransCelerate representative )

2. Catherine Yi-San Lee(Pfizer) 

상기 과정은 보수과정으로 직능별, 단계별 인정가능시간이 상이함으로 관련규정 '[별표1] 임상시험등 종사자별 교육과정 및 이수시간'을 꼭 확인하시기 바랍니다.

[별표 1]

임상시험등 종사자별 교육과정 및 이수시간

(제5조 관련)