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New Approaches to Pharmacovigilance & Their Applications to Clinical Development?_공통보수

구분 온라인교육
카테고리온라인 > KoNECT International Conference_공통 > 2018 KoNECT International Conference
과정명New Approaches to Pharmacovigilance & Their Applications to Clinical Development?
신청기간 상시 교육기간 -
학습일수/시간 30 일 / 65 분 교육장소 미정
수강료 무료 교육정원인원제한없음
  • 소개
  • 목차
  • 교육일정
학습개요

?ICH E19: Update and Expectation from Industry


?Seong Choon Choe(Boryung Pharmaceutical)

ICH E19, a new guideline is proposed to provide internationally harmonized guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post- marketing studies, and how such an approach would be implemented.
The guideline is currently step 1 and there is the right time for input from pharmaceutical industry. So I would like to discuss what industry wants to get with this guideline.
By tailoring safety data collection in some circumstances, the burden to patients would be reduced, a larger number of informative clinical studies could be carried out with greater efficiency, studies could be conducted with greater global participation, and the public health would be better served.
But there is no widely adopted guidance on when the use of targeted safety data collection would be appropriate in late-stage pre-marketing or post-marketing studies, or on how to implement such an approach. Thus, this topic represents an ideal opportunity for international harmonization.
Recognizing that protection of patient welfare during drug development is critically important, unnecessary data collection may be burdensome to patients, and serve as a disincentive to participation in clinical research. Regulators and industry have a shared interest in reducing the burden to patients and facilitating the conduct of studies that could yield important new medical knowledge and advance public health.
The guideline is currently step 1 and there is the right time for input from pharmaceutical industry. So I would like to discuss what industry wants to get with this guideline.?

 

?Pharmacovigilance for Oncology Combination Studies with Checkpoint Inhibitors


Stewart Geary(Esai)

Immunotherapy using checkpoint inhibitors has led to significant improvements in patient outcomes across a variety of tumor types and stages of disease. Recently attention has turned to combination studies using chemotherapy or molecularly targeted agents with checkpoint inhibitors in order to broaden the range of patients who benefit from immune- oncology and further improve patient survival. Pharmacovigilance for such combination studies can be challenging both because of the differing toxicities associated with these individual therapies, the different timelines over which toxicity may be anticipated for small molecule as compared to antibody therapies and the theoretical potential for overlap or augmentation of important toxicities such as interstitial pneumonia and hepatotoxicity. This presentation will present considerations for pharmacovigilance during clinical studies of these combinations.

 

?Innovative Technology for Case Intake to Enable Process Improvements and Focus on Data Analysis


Jamie Portnoff (Foresight)

Case Intake presents a significant issue for industry. Multiple and increasing sources, poor quality of initial data, multiple formats and platforms all combine to make Intake an expensive and error prone process that compromises case quality, has been difficult to optimise and takes resources from data analysis to data input.
Innovations in case intake enable a greater investment in value-added data analysis, which in turn supports the broader goal of maintaining products on the market with accurate safety profiles.
Multiple case studies will be shared to highlight different approaches taken within industry, ranging from small biotechs to the largest pharma companies. The unique challenges faced by each company leading them to pursue solutions for case intake, as well as the benefits and high-level return-on-investment realized by each company will be described with the case studies. A brief demonstration of a technical solution will be provided.
Innovations in case intake enable a greater investment in value-added data analysis, which in turn supports the broader goal of maintaining products on the market with accurate safety profiles.?

학습목표

Seong Choon Choe(Boryung Pharmaceutical)

Stewart Geary(Esai)

Jamie Portnoff (Foresight) 

교육대상

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

(5조 관련)

교육과정

해당 분야 실시경험이

없는 종사자

해당 분야 실시경험이 있는 종사자2)

신규자 교육과정

(우선교육시간)1)

심화 교육과정

보수 교육과정

 . 임상시험등 시험책임자3), 시험담당자4)

8시간 이상

(4시간 이상)

6시간 이상

4시간 이상

 . 심사위원회 위원

의사등3)

8시간 이상

(4시간 이상)

6시간 이상

4시간 이상

그 밖의 위원

12시간 이상

(6시간 이상)

6시간 이상

4시간 이상

 . 관리약사

8시간 이상

(4시간 이상)

6시간 이상

4시간 이상

 . 임상시험등 모니터요원

40시간 이상

(20시간 이상)

24시간 이상

8시간 이상

 . 임상시험등 코디네이터

 . 임상시험등 실시기관 품질보증 담당자

 . 임상시험등 업무 담당자5)

4시간 이상

(2시간 이상)

3시간 이상

2시간 이상

1) 규칙 제38조의23항 후단 및 제5조제2항에 따라 임상시험등 업무 경력이 없는 사람이 그 업무를 시작하기 전에 받아야 하는 교육시간을 말한다.

2) 보수교육과정은 평가를 생략할 수 있고, 해당 교육과정의 교육대상이면서 교육을 실시한 경우에는 교육시간을 이수시간으로 인정하며, 심포지엄, 워크숍, 온라인 교육 등으로 이수할 수 있으며, 이수시간의 최대 50/100까지 인정된다.

3) 의사 등이 시험책임자?시험담당자 교육과정에서 이수 받은 교육시간은 심사위원회 교육과정에서 이수 받은 교육시간으로 보며, 반대의 경우도 동일하게 적용한다.

4) 의약품 등의 안전에 관한 규칙[별표 4] 의약품 임상시험 관리기준 제2호코목에 따른 시험당당자(Subinvestigator)를 말한다.

5) 시험담당자(Subinvestigator), 관리약사, 임상시험등 코디네이터를 제외한 시험책임자의 위임 및 감독에 따라 임상시험등 업무를 담당하는 사람(임상병리사, 방사선사 등)을 말한다.

 

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