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药时代2020年活动计划(20191003版本)

药时代活动 药时代 2019-12-11

正文共: 5630字 14图

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 January 2 and March 31 of 2020, to be 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
2020 International Conference on NASH Drugs and The First Annual Meeting of China NASH New Drug Alliance


时间:2020年3月15日至31日期间,具体时间待定

Time: between March 15 and 31 of 2020, to be 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: 07-13 June 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 FDA Regulations for Drugs, Medical Devices and Combo Products


主讲:Janet Fourman博士

Instructor: Janet Fourman, 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 Third Workshop on FDA Regulations for Drugs, Medical Devices and Combo Products


主讲:Janet Fourman博士

Instructor: Janet Fourman, Ph.D.


时间:2020年9月至11月,具体时间待定

Time: between September and November 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: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


课程大纲

 

 

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):

o   New Chemical Entities, Breakthrough Therapy, FastTrack Review

o   Patents and exclusivity

o   Generic vs. prescription drugs

o   Nonprescription drugs

·      Good Regulatory Practices (4 hours):

o   GLPs, GMPs, GCPs, GXPs

o   Statistical applications

o   eCTD modules 1-5

o   Target Product Profile and Quality Target Product Profile

Day 2:

·      Pharma Quality (4 hours):

o   International quality systems

o   Postapproval submissions and compliance

o   Prescription drug labeling

o   Pharmacovigilance

o   Risk management

·      NewTherapies (4 hours):

o   Biologics, biosimilars, biobetters

o   Blood products

o   Human cell and tissue products

o   Genetic therapies

o   Rare diseases

 
Outline of Medical Device and Combination Product Workshop

Day 3:

·      Good Device Submission Practices (4 hours)

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

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

o   Interpret the meaning and implementation of these spractices from a global perspective

o   Recognize the roles and responsibility of regulatory of regulatory professionals overseeing these practices

·      Device Manufacturing Basics (2 hours)

o   Recognize continuous manufacturing as an option to improve and sustain manufacturing operations

o   Understand Quality by Design (QbD) principles

·      Quality Management (2 hours)

o   Emphasize Quality System Regulations (QSR)

o   Prepare for audits and inspections

Day 4:

·      Device Statistics (2 hours)

o   Understand Statistical Process Control (SPC)

o   Comprehend Design of Experiments (DOE)

o   Utilize descriptive and inferential statistics fordevice specifications

·      Medical Device Lifecycle Management (2 hours)

o   Recognize the importance of the supply chain

o   Process Medical Device Reporting (MDR)

o   Emphasize medical device tracking

o   Define the import/export requirements

·      Biometric Technologies (2 hours)

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

o   Explore the impact of social media platforms on health reported outcomes

·      Medical Device Emerging Technologies (2 hours)

o   Recognize the emerging medical mobile app industry

o   Realize how AI and other robotics will enhance medical devices

o   Explore the cognitive and human factors of medical devices

 

Day 5:

·      In Vitro Diagnostic Submissions and Compliance (2 hours)

o   Understand the pre-submission process, regulatory submission types and their requirements

o   Comprehend the concept of therapeutic product and companion diagnostic co-development

·      Combination Products (6 hours)

o   Product definition

o   Determine combination product and regulatory path

o   Premarket review

o   Postapproval modifications

o   Good manufacturing practice requirements

o   Postmarket safety reporting for combination products

o   Combination product user fees

o   Combination product review

o   New combination products guidances and regulations



往期活动精彩回顾


88张照片,记录Peter Baker老师中国"首秀"的精彩瞬间!

精彩回放!"新靶点 新技术 新机遇 助力新跨越!—— 2019中国抗肿瘤药高峰论坛"成功举办!

2019年NASH大会精彩瞬间!高朋满座 大咖云集!


走进新时代 谱写新篇章!— 2017中国新药研发立项与投融资高峰对话圆满举办!

FDA药品最新法规及注册策略研修班成功举办!

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