药时代2020年活动计划(20191003版本)

原文始发于微信公众号(药时代):药时代2020年活动计划(20191003版本)

药时代2020年活动计划(20191003版本)

正文共:563014

预计阅读时间:15分钟

1

第一期中国新药企业战略研修班
The First Workshop on Strategy for China New Drug Developers

主讲:即将宣布

Instructor: To be announced

时间:2020年1月2日至3月31日期间,具体时间待定

Time: between January2and March 31of 2020, tobe determined

时长:3天

Days:3 days

地点:上海浦东

Location: Shanghai Pudong

预计人数:50人

Planned attendance: 50

参会费(人民币):8000元

Fee (RMB): 8000

日程安排:准备中

Agenda:In preparation

2

2020年NASH新药国际大会暨中国NASH新药联盟第一届年会
2020International Conference on NASH Drugs andThe FirstAnnual Meeting of China NASH New DrugAlliance

时间:2020年3月15日至31日期间,具体时间待定

Time: betweenMarch15 and 31of 2020, tobe determined

时长:两天

Days:2 days

地点:上海浦东

Location: Shanghai Pudong

预计人数:500人

Planned attendance: 500

参会费(人民币):4000元

Fee (RMB): 4000

日程安排:准备中

Agenda: In preparation

3

第二期数据可靠性培训班
The Second Data Integrity Workshop

主讲:Peter Baker先生,Monica Cahilly女士

Instructor: Mr. Peter Baker, Ms. Monica Cahilly

时间:2020年6月7-13日,具体时间待定

Time:07-13June 2020, to be finalized

时长:Level 1(两天);Level 2(两天);Level 3(两天)

Duration: Level 1 (2 days); Level 2 (2 days); Level 3 (2 days)

地点:上海浦东

Location: Shanghai Pudong

预计人数:Level 1(150);Level 2(150);Level 3(150)

Planned attendance: Level 1 (150); Level 2 (150); Level 3 (150)

参会费(RMB):Level 1(5000);Level 2(5000);Level 3(5000)

Fee (RMB): Level 1 (5000); Level 2 (5000); Level 3 (5000)

课程大纲:准备中

Class Outline: In preparation

4

第二期FDA药品、医疗器械及组合产品法规培训班

The Second Workshop on FDARegulationsforDrugs, Medical Devices and Combo Products

药时代2020年活动计划(20191003版本)

主讲:Janet Fourman博士

Instructor: JanetFourman,Ph.D.

时间:2020年4月至6月,具体时间待定

Time: between April and June of 2020, to be finalized

时长:药品(两天);医疗器械及组合产品(三天)

Duration: Drugs (2 days); Medical Device and Combo(3 days)

地点:上海浦东

Location: Shanghai Pudong

预计人数:药品(200人);医疗器械及组合产品(200人)

Planned attendance: Drugs (200); Medical device and combo(200)

参会费(人民币):药品(5000);医疗器械及组合产品(6000)

Fees (RMB):Drugs(5000); Medical device and combo(6000)

课程大纲:请见最后页

Class Outline:Please see below

5

第三期数据可靠性培训班

The Third Data Integrity Workshop

主讲:Peter Baker先生,Monica Cahilly女士

Instructor: Mr. Peter Baker, Ms. Monica Cahilly

时间:2020年10月18-24日,具体时间待定

Time:18-24 October 2020, to be finalized

时长:Level 1(两天);Level 2(两天);Level 3(两天)

Duration: Level 1 (2 days); Level 2 (2 days); Level 3 (2 days)

地点:北京

Location: Beijing

预计人数:Level 1(150);Level 2(150);Level 3(150)

Planned attendance: Level 1 (150); Level 2 (150); Level 3 (150)

参会费(RMB):Level 1(5000);Level 2(5000);Level 3(5000)

Fee (RMB): Level 1 (5000); Level 2 (5000); Level 3 (5000)

课程大纲:准备中

Class Outline: In preparation

6

第三期FDA药品、医疗器械及组合产品法规培训班
The ThirdWorkshop on FDARegulationsforDrugs,Medical Devices and Combo Products

主讲:Janet Fourman博士

Instructor: JanetFourman,Ph.D.

时间:2020年9月至11月,具体时间待定

Time: between Septemberand Novemberof 2020, to be finalized

时长:药品(两天);医疗器械及组合产品(三天)

Duration:Drugs(2 days); Medical Device and Combo(3 days)

地点:北京

Location: Beijing

预计人数:药品(200人);医疗器械及组合产品(200人)

Planned attendance: Drugs (200); Medical device and combo(200)

参会费(人民币):药品(5000);医疗器械及组合产品(6000)

Fees(RMB):Drugs(5000); Medical device and combo(6000)

课程大纲:请见最后页

Class Outline:Please see below

7

药时代线上系列活动
DrugTimes Online Activities

活动内容:准备中

Activity Outline:In preparation

药时代2020年活动计划(20191003版本)

课程大纲

药时代2020年活动计划(20191003版本)

FDA药品、医疗器械及组合产品法规培训班课程大纲

Outline of Pharma Workshop

Day 1:

·Pharma Product Submissions (4 hours):

oNew Chemical Entities, Breakthrough Therapy, FastTrack Review

oPatents and exclusivity

oGeneric vs. prescription drugs

oNonprescription drugs

·Good Regulatory Practices (4 hours):

oGLPs, GMPs, GCPs, GXPs

oStatistical applications

oeCTD modules 1-5

oTarget Product Profile and Quality Target Product Profile

Day 2:

·Pharma Quality (4 hours):

oInternational quality systems

oPostapproval submissions and compliance

oPrescription drug labeling

oPharmacovigilance

oRisk management

·NewTherapies (4 hours):

oBiologics, biosimilars, biobetters

oBlood products

oHuman cell and tissue products

oGenetic therapies

oRare diseases

Outline of Medical Device and Combination Product Workshop

Day 3:

·Good Device Submission Practices (4 hours)

oReview device discovery and development with emphasis on the international regulatory aspects of these activities

oReview FDA, EMA and ICH regulations on good manufacturing, good laboratory, and good clinical practices

oInterpret the meaning and implementation of these spractices from a global perspective

oRecognize the roles and responsibility of regulatory of regulatory professionals overseeing these practices

·Device Manufacturing Basics (2 hours)

oRecognize continuous manufacturing as an option to improve and sustain manufacturing operations

oUnderstand Quality by Design (QbD) principles

·Quality Management (2 hours)

oEmphasize Quality System Regulations (QSR)

oPrepare for audits and inspections

Day 4:

·Device Statistics (2 hours)

oUnderstand Statistical Process Control (SPC)

oComprehend Design of Experiments (DOE)

oUtilize descriptive and inferential statistics fordevice specifications

·Medical Device Lifecycle Management (2 hours)

oRecognize the importance of the supply chain

oProcess Medical Device Reporting (MDR)

oEmphasize medical device tracking

oDefine the import/export requirements

·Biometric Technologies (2 hours)

oGain an understanding of the sciences and technologies used to measure and study unique biological traits to safeguard patient identity

oExplore the impact of social media platforms on health reported outcomes

·Medical Device Emerging Technologies (2 hours)

oRecognize the emerging medical mobile app industry

oRealize how AI and other robotics will enhance medical devices

oExplore the cognitive and human factors of medical devices

Day 5:

·In Vitro Diagnostic Submissions and Compliance (2 hours)

oUnderstand the pre-submission process, regulatory submission types and their requirements

oComprehend the concept of therapeutic product and companion diagnostic co-development

·Combination Products (6 hours)

oProduct definition

oDetermine combination product and regulatory path

oPremarket review

oPostapproval modifications

oGood manufacturing practice requirements

oPostmarket safety reporting for combination products

oCombination product user fees

oCombination product review

oNew combination products guidances and regulations

药时代2020年活动计划(20191003版本)

药时代2020年活动计划(20191003版本)
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药时代2020年活动计划(20191003版本)

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