[KIC > 보수]
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교육일정
● Clinical Trial Regulation Implementation in Germany
Janet Koenig(BfArM)
The new European Clinical Trials Regulation 536/2014 will replace the still valid European Directive 2001/20/EC. The legislation becomes a regulation, rather than a directive, which will ensure key aspects have identical rules throughout the EU. The new regulation aims to harmonise authorisation and reporting procedures for clinical trials and introduces of a joint European assessment for multinational clinical trials in the EU. Despite the joint assessment administered by a reporting member state, however, each member state will continue to authorise clinical trial applications nationally. The new procedures will also require close cooperation between the competent authorities and national ethics committees in the assessment of clinical trial applications. In Germany, a pilot project was started to simulate the future processes of the regulation in line with current legal requirements and in order to give applicants, competent authorities and ethics committees the opportunity to get familiar with the new procedures.
Compliance with the deadlines set by competent authorities and ethics committee shows that the technical infrastructures and processes established in the pilot procedure are fully functional. From the perspective of the parties involved, the cooperation between competent authorities and ethics committees was seen to be very successful.
● Regulatory Reform to Support Clinical Development of Innovative Products in China
Ling Su(China)
Since June 2015, China has implemented an unprecedented comprehensive reform of its regulatory system. In June 2017, the Chinese regulatory agency became a regulatory member of ICH. All of these have brought about significant changes to many aspects of new drug development, approval and regulation in China and have important impact on all stakeholders including the industry, research organizations and the regulatory agency. In this brief presentation, the following topics will be discussed:
- Acceptance of overseas clinical data to support drug registration in China, particularly in the context of multi-regional clinical trial (MRCT) and ICH E17
- Acceptance of overseas clinical data to support drug registration in China, particularly in the context of multi-regional clinical trial (MRCT) and ICH E17?
● Preparedness and Execution of Chinese Regulatory Reform
Chang Lee(PAREXEL)
China is the 2nd largest pharmaceutical market worldwide, and an attractive country for biopharmaceutical companies to conduct clinical research. The major drivers of the growth include the unmet medical needs, the expanding middle class, stronger belief in innovation economics, greater in-flows of investment, and the central government’s policies. As of September 1, 2018, the Chinese FDA “CFDA” English abbreviation has officially been changed to NMPA - National Medical Products Administration. NMPA approval timelines have been dramatically reduced: there were 324 new drug applications in 2017; CTA approval was 110 days in 2017, and it is 57 days in 2018. The NMPD/CDE reviewers grown from 120 to 800 in a short time. Foreign data can be accepted for registration if there is no ethnic difference in the patient population; In July 2018, a list of 48 drug products approved outside of China but not yet in China was published by NMPA for priority review. Those 48 products can be approved in 3-6 months based upon overseas data. Innovative drugs can now be listed in the National Reimbursement Drug List (NRDL) through price negotiation with the government. China approves 17 anti-cancer drugs for medical insurance coverage on October 10, 2018. This talk will present relevant regulatory, clinical & product launch strategies, four clinical innovations that have promise in decreased patient recruitment timelines, increased likelihood of launch, and inclusion on payer formularies, and multichannel communications with NMPA/CDE to obtain development agreements.
1. Janet Koenig(BfArM)
2. Ling Su(China)
3. Chang Lee(PAREXEL)
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)
교육과정 | 해당 분야 실시경험이 없는 종사자 | 해당 분야 실시경험이 있는 종사자2) | ||
신규자 교육과정 (우선교육시간)1) | 심화 교육과정 | 보수 교육과정 | ||
가. 임상시험등 시험책임자3), 시험담당자4) | 8시간 이상 (4시간 이상) | 6시간 이상 | 4시간 이상 | |
나. 심사위원회 위원 | 의사등3) | 8시간 이상 (4시간 이상) | 6시간 이상 | 4시간 이상 |
그 밖의 위원 | 12시간 이상 (6시간 이상) | 6시간 이상 | 4시간 이상 | |
다. 관리약사 | 8시간 이상 (4시간 이상) | 6시간 이상 | 4시간 이상 | |
라. 임상시험등 모니터요원 | 40시간 이상 (20시간 이상) | 24시간 이상 | 8시간 이상 | |
마. 임상시험등 코디네이터 | ||||
바. 임상시험등 실시기관 품질보증 담당자 | ||||
사. 임상시험등 업무 담당자5) | 4시간 이상 (2시간 이상) | 3시간 이상 | 2시간 이상 | |
1) 규칙 제38조의2제3항 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. |
평가기준 | 집합 출석율 | 온라인 진도율 | 시험 | 과제 | 토론 | 기타 |
---|---|---|---|---|---|---|
배점비율 | - | 100.00% | - | - | - | - |
과락기준 | - | 100% | - | - | - | - |