药时代2020年活动计划
1
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
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
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 of 01-07 March 2020 or week of 07-13 June 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
4
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
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 of 04-10 October 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
6
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
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
· 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
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
· 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
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