原文始发于微信公众号（药时代）：药时代2020年活动计划
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
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
主讲：Peter Baker先生，Monica Cahilly女士
Instructor: Mr. Peter Baker, Ms. Monica Cahilly
时间：2020年3月1-7日，或6月7-13日，具体时间待定
Time:Either the week of01-07March 2020 or week of07-13June 2020 for Shanghai Pudong, 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
The Second Workshop on FDARegulationsforDrugs, Medical Devices and Combo Products
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
主讲：Peter Baker先生，Monica Cahilly女士
Instructor: Mr. Peter Baker, Ms. Monica Cahilly
时间：2020年10月4-10日，或10月18-24日，具体时间待定
Time: Either the week of04-10October 2020 or week of 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
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
药时代线上系列活动
活动内容：准备中
Activity Outline:In preparation
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
·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
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
·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
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