Популярное

Музыка Кино и Анимация Автомобили Животные Спорт Путешествия Игры Юмор

Интересные видео

2025 Сериалы Трейлеры Новости Как сделать Видеоуроки Diy своими руками

Топ запросов

смотреть а4 schoolboy runaway турецкий сериал смотреть мультфильмы эдисон
dTub
Скачать

Electronic Submission of Adverse Event Reports to FAERS using ICH E2B(R3) Standards - Oct. 11, 2019

Автор: U.S. Food and Drug Administration

Загружено: 2020-01-17

Просмотров: 4246

Описание:

Suranjan De from CDER’s Office of Surveillance & Epidemiology discusses plans, progress, and technical specifications on enhancements to electronic submission of premarket and post-market Individual Case Safety Reports (ICSRs) in FAERS using ICH E2B(R3) standards.

Find more information at https://www.fda.gov/drugs/cder-small-...

_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Visit https://www.fda.gov/cdersbia and https://www.fda.gov/cdersbialearn for news and a repository of training activities.

Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
LinkedIn:   / cder-small-business-and-industry-assistance  
Twitter:   / fda_drug_info  
CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm...

Electronic Submission of Adverse Event Reports to FAERS using ICH E2B(R3) Standards - Oct. 11, 2019

Поделиться в:

Доступные форматы для скачивания:

Скачать видео mp4

  • Информация по загрузке:

Скачать аудио mp3

Похожие видео

Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS)- Nov. 1, 2019

Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS)- Nov. 1, 2019

Medical Device Quality Management System Regulation Risk Management

Medical Device Quality Management System Regulation Risk Management

Framework for FDA’s Real-World Evidence Program – Mar 15, 2019

Framework for FDA’s Real-World Evidence Program – Mar 15, 2019

Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards

Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards

Good Clinical Practice & Pharmacovigilance Compliance Symposium | D3S03-2 – Q&A Discussion Panel

Good Clinical Practice & Pharmacovigilance Compliance Symposium | D3S03-2 – Q&A Discussion Panel

FDA Direct: Catching Up on Agency Reforms

FDA Direct: Catching Up on Agency Reforms

Quality and Control of Clinical Trial Data (6of11) GCP Data Integrity Workshop

Quality and Control of Clinical Trial Data (6of11) GCP Data Integrity Workshop

eCTD Submissions of Promotional Labeling and Advertising Materials

eCTD Submissions of Promotional Labeling and Advertising Materials

Conversations on Cancer – Perspectives on Cancer Care Decision-Making Among Older Adults

Conversations on Cancer – Perspectives on Cancer Care Decision-Making Among Older Adults

Good Clinical Practice & Pharmacovigilance Compliance Symposium | D3S07 – Q&A Discussion Panel

Good Clinical Practice & Pharmacovigilance Compliance Symposium | D3S07 – Q&A Discussion Panel

FDA Expert Panel on Testosterone Replacement Therapy for Men

FDA Expert Panel on Testosterone Replacement Therapy for Men

Medical Device Quality Management System Regulation Design and Development

Medical Device Quality Management System Regulation Design and Development

Initiating the Removal of the “Black Box Warning” on Hormone Replacement Therapy

Initiating the Removal of the “Black Box Warning” on Hormone Replacement Therapy

Public Meeting: Reauthorization of the Biosimilar User Fee Act

Public Meeting: Reauthorization of the Biosimilar User Fee Act

Overview of Postmarketing Drug Safety Reporting Requirements - REdI 2020

Overview of Postmarketing Drug Safety Reporting Requirements - REdI 2020

FDA Direct: FDA Awards Six National Priority Vouchers

FDA Direct: FDA Awards Six National Priority Vouchers

Tobacco Products Scientific Advisory Committee Meeting, October 7, 2025

Tobacco Products Scientific Advisory Committee Meeting, October 7, 2025

GCP & Pharmacovigilance Compliance Symposium | D3S03-1 - (BE): Clinical Study Conduct

GCP & Pharmacovigilance Compliance Symposium | D3S03-1 - (BE): Clinical Study Conduct

Good Clinical Practice & Pharmacovigilance Compliance Symposium | D3S05 - (PV): Future of...

Good Clinical Practice & Pharmacovigilance Compliance Symposium | D3S05 - (PV): Future of...

FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)

FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)

© 2025 dtub. Все права защищены.



  • Контакты
  • О нас
  • Политика конфиденциальности



Контакты для правообладателей: infodtube@gmail.com