guideline

Cooperative Placement Guide

INTRODUCTION

Students of the School of Social Sciences and Liberal Arts - Bachelor of Arts (Honors) in English Language and Communication are required to do three cooperative placements. In each cooperative placement, students are requested to work or do their internship for two months at the end of every year of study. However, graduating students may do their final cooperative placement upon completion of all subjects (excluding cooperative placement) any time of the year. This cooperative placem

GUIDELINE FOR DRUG MASTER FILES

Center for Drug Evaluation and Research

Food and Drug Administration

Department of Health and Human Services

September 1989

For further information regarding the guideline please contact:

Food and Drug Administration

Center for Drug Evaluation and Research Office of Drug Evaluation I (HFD-100)

5600 Fishers Lane Rockville, Maryland 20857

TABLE OF CONTENTS

I. INTRODUCTION II. DEFINITIONS

III. TYPES OF DRUG MASTER FILES IV. SUBMISSIONS TO DRUG MASTER FILES

A. Transmittal Letters

1. Origin

EMEA

European Medicines Agency Pre-Authorisation Evaluation of Medicines for Human Use

London, 19 February 2009 Doc. Ref. EMEA/CHMP/EWP/15839/2009 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE

(CHMP)

CONCEPT PAPER ON THE NEED FOR A GUIDELINE ON THE EVALUATION OF

DRUGS FOR THE TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD)

AGREED BY EFFICACY WORKING PARTY

ADOPTION BY CHMP FOR RELEASE FOR CONSULTATION END OF CONSULTATION (DEADLINE FOR COMMENTS)

Comments should be provided using this to

KEYWORDS

Gastroesophageal Reflux Disease

EMEA

European Medicines Agency Pre-Authorisation Evaluation of Medicines for Human Use

London, 19 February 2009 Doc. Ref. EMEA/CHMP/EWP/15839/2009 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE

(CHMP)

CONCEPT PAPER ON THE NEED FOR A GUIDELINE ON THE EVALUATION OF

DRUGS FOR THE TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD)

AGREED BY EFFICACY WORKING PARTY

ADOPTION BY CHMP FOR RELEASE FOR CONSULTATION END OF CONSULTATION (DEADLINE FOR COMMENTS)

Comments should be provided using this to

KEYWORDS

Gastroesophageal Reflux Disease

2016年中国经皮冠状动脉介入治疗指南

中华心血管病杂志2016年5月第44卷第5期 Chin J Cardiol,May 2016,Vol.44 No.5

指南与共识

自\中国经皮冠状动脉介入治疗指南2012(简本)\[1]更新以来，在经皮冠状动脉介入治疗(percutaneous coronary intervention，PCI)及其相关领域又积累了众多临床证据。为此，中华医学会心血管病学分会介入心脏病学组、中国医师协会心血管内科医师分会血栓防治专业委员会、中华心血管病杂志编辑委员会组织专家组，在2009和2012年中国PCI指南[1,2]的基础上，根据最新临床研究成果、特别是结合中国人群的大型随机临床试验结果，参考最新美国心脏病学学院/美国心脏协会(ACC/AHA)以及欧洲心脏病学学会(ESC)等组织发布的相关指南

[3,4,5,6,7,8,9]

、并结合我国国情及临床实践，对PCI治疗领域的热点和焦点问题进行了全面讨论并达成一致共识，在此 为便于读者了解PCI对某一适应证的价值或意义，本指南对推荐类别的表述沿用国际通用的方式。 Ⅰ类：指已证实和(或)一致公认有益、有用和有效的操作或治疗，推荐使用。 Ⅱ类：指有用和(或)有效