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국외 약물감시 규정 자료집 1
| 작성자 | 관리자 | ||
|---|---|---|---|
| 작성일 | 2013-05-02 | 조회수 | 1,416 |
| 원문 | 식품의약품안전평가원 | ||
| 출처 | http://www.nifds.go.kr/nifds/03_info/service01.jsp?mode=view&article_no=5516&pager.offset=0&search:search_category:category=22&search:search_key:search=article_title&search:search_val:search=&board_no=80 | ||
| 첨부파일 | |||
국외_약물감시_규정_자료집_1.pdf(33.63MB)
교육내용
1. Development and Use of Risk Minimization Action Plans
2. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
3. Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report
4. Best Practices for Conducting and Reporting Pharmacoepi demiologic Safety Studies Using Electronic Healthcare Data Setsm
5. Medication Guides - Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)
6. Safety Labeling Changes - Implementation of the Federal Food, Drug, and Cosmetic Act
7. Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Apporoved Application
8. Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
9. Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines
10. Reports on the Status of Postmarketing Study Commitments - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997
11. Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products - Content and Format
※ 자세한 내용은 아래 원문 URL을 이용하시기 바랍니다.
국외 약물감시 규정 자료집 1 입니다.
많은 활용 바랍니다.
※ 이 자료집의 한글 번역문은 해당 용어 및 정의에 대한 식품의약품안전처의 공식적 입장은 아님을 밝히며, 수정 및 기타 의견이 있으신 경우에는 식품의약품안전평가원 임상연구과(043)719-5255 또는 jihyeha@korea.kr
)로 연락 주시기 바랍니다.
1. Development and Use of Risk Minimization Action Plans
2. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
3. Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report
4. Best Practices for Conducting and Reporting Pharmacoepi demiologic Safety Studies Using Electronic Healthcare Data Setsm
5. Medication Guides - Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)
6. Safety Labeling Changes - Implementation of the Federal Food, Drug, and Cosmetic Act
7. Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Apporoved Application
8. Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
9. Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines
10. Reports on the Status of Postmarketing Study Commitments - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997
11. Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products - Content and Format
※ 자세한 내용은 아래 원문 URL을 이용하시기 바랍니다.
