Training Webinar on FDA Regulations Session 1 Pre-registration

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Training Webinar on FDA Regulations Session 1 Pre-registration

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美国FDA法规培训网络视频课程 | Training Webinar on FDA Regulations

本系列培训课程由“明月药械中美咨询”与“药时代”联合举办,由具有几十年美国和全球药品,医疗器械,及IVD注册经验的美国专家Janet Fourman博士、Gary Fourman博士主讲。

This series of training courses is co-organized by MinYue-Pharos Consulting, LLC and DrugTimes, presented by Dr. Jane Fourman and Dr. Gary Fourman, American experts with decades of experience in US and global pharmaceuticals, medical devices, and IVD registrations. 



60 hours in 5 sessions. Through study, students and friends will have a systematic and in-depth understanding of the latest FDA regulations, and can immediately apply in pharmaceutical research and development. This course is suitable for R&D professionals in pharmaceutical R&D companies, biotechnology companies, clinical trials, lecturers or students of university regulatory affairs, and professionals engaged in registration, clinical supervision, quality system creation and management.

Friends who finish the course will receive a certificate to be signed by Dr. Janet Fourman, Dr. Gary Fourman, Ms. Min Yue and Dr. Jinsong Guo.


The demo class on 2019-04-08 went very well. Many thanks to ~80 friends for their strong support!


Herein, we post the registration notice along with the registration link.

Session 1

Duration: 12 hours in 6 classes

Full Fee: 3000 RMB / 450 USD

If attending from 2019-05-11, the fee is 2000 RMB / 300 USD


  1. History of US Food, Drug and Cosmetic Laws (Jan)

  2. Pharma Research Ethics – ICH, WHO (Jan)

  3. Prescription Drug Product Submissions – New Chemical Entities, Breakthrough Therapy, Fast Track Review (Jan)

  4. Generic versus Prescription Drugs (Jan)

  5. Patents and Exclusivity (Jan)

  6. Over-the-Counter (OTC) Nonprescription Drugs (Jan)

Class time (Beijing Time):

  1. 2019-04-20 Saturday 8:00-10:00 AM (already completed)

  2. 2019-04-21    Sunday 8:00-10:00 PM (already completed)

  3. 2019-05-11 Saturday 8:00-10:00 AM

  4. 2019-05-12    Sunday 8:00-10:00 PM

  5. 2019-05-18 Saturday 8:00-10:00 AM

  6. 2019-05-19    Sunday 8:00-10:00 PM

Registration Link:


报名截止日期:2019-05-10 星期五

Deadline for registration: 2019-05-10 Friday

Session 2

Duration: 20 hours in 10 classes

Fee: 5000 RMB / 750 USD


  1. Nonclinical Studies of Drug Products – Toxicology, Pharmacodynamics, Pharmacokinetics (Jan)

  2. Good Laboratory Practices (GLPs) (Jan)

  3. Clinical Trials of Drug Products – Trial Phases 1 through 4 (Jan)

  4. Good Clinical Practices (GCPs) (Jan)

  5. Clinical Trials for Oncology (Jan)

  6. Clinical Trials Design and Statistics (Jan)

  7. Statistical Applications (Gary)

  8. Chemistry, Manufacturing and Controls (Gary)

  9. Good Manufacturing Practices (GMPs) (Gary)

  10. Good Manufacturing Practices (GMPs) Sterile Products (Gary)

Class time (Beijing Time):

  1. 2019-05-25 Saturday 8:00-10:00 AM

  2. 2019-05-26    Sunday 8:00-10:00 PM

  3. 2019-06-01 Saturday 8:00-10:00 AM

  4. 2019-06-02    Sunday 8:00-10:00 PM

  5. 2019-06-08 Saturday 8:00-10:00 AM

  6. 2019-06-09    Sunday 8:00-10:00 PM

  7. 2019-06-15 Saturday 8:00-10:00 AM

  8. 2019-06-16    Sunday 8:00-10:00 PM

  9. 2019-06-22 Saturday 8:00-10:00 AM

  10. 2019-06-23   Sunday 8:00-10:00 PM

Registration Link:


报名截止日期:2019-05-09 星期四

Deadline for registration: 2019-05-09 Thursday

Session 3

Duration: 14 hours in 7 classes

Fee: 3500 RMB / 525 USD


  1. Quality Systems – ICH, ISO, Electronic Systems (Jan and Gary)

  2. Post-approval Prescription Drug Submissions and Compliance (Jan)

  3. Prescription Drug Labeling (Jan)

  4. Pharmacovigilance – Patients, Manufacturing (Jan and Gary)

  5. Risk Management (Jan)

Class time (Beijing Time):

  1. 2019-06-29 Saturday 8:00-10:00 AM

  2. 2019-06-30    Sunday 8:00-10:00 PM

  3. 2019-07-06 Saturday 8:00-10:00 AM

  4. 2019-07-07    Sunday 8:00-10:00 PM

  5. 2019-07-13 Saturday 8:00-10:00 AM

  6. 2019-07-14    Sunday 8:00-10:00 PM

  7. 2019-07-20 Saturday 8:00-10:00 AM

Registration Link:


报名截止日期:2019-06-13 星期四

Deadline for registration: 2019-06-13 Thursday

Session 4

Duration: 8 hours in 4 classes

Fee: 2000 RMB / 300 USD


  1. Biologics Introduction and Submissions (Jan)

  2. Biologics Clinical Testing(Jan)

  3. Biologics Compliance (Jan)

  4. Biosimilars (Jan)

Class time (Beijing Time):

  1. 2019-07-21    Sunday 8:00-10:00 PM

  2. 2019-07-27 Saturday 8:00-10:00 AM

  3. 2019-07-28    Sunday 8:00-10:00 PM

  4. 2019-08-03 Saturday 8:00-10:00 AM

Registration Link:


报名截止日期:2019-07-05 星期五

Deadline for registration: 2019-07-05 Friday

Session 5

Duration: 6 hours in 3 classes

Fee: 1500 RMB / 225 USD


  1. Blood and Blood Products (Jan)

  2. Products for Subpopulations –Pediatrics, Geriatrics, Rare Diseases (Jan)

  3. Human Cell and Tissue Products (Jan)

Class time (Beijing Time):

  1. 2019-08-04    Sunday 8:00-10:00 PM

  2. 2019-08-10 Saturday 8:00-10:00 AM

  3. 2019-08-11    Sunday 8:00-10:00 PM

Registration Link:


报名截止日期:2019-07-19 星期五

Deadline for registration: 2019-07-19 Friday

如 何 注 册 ?

(1) 请复制黏贴每个session的报名链接或扫描二维码,填写表单,支付学费。

(2) 我们将在每个session的每节课开课的至少一天前把gotowebinar的链接发到您的电子邮箱中。

(3) 请阅读您收到的邮件,进行gotowebinar软件准备和您的电脑/手机系统的测试(如果是第一次使用gotowebinar的话)。

(4) 请按照每一节课的时间准时上课。

How to register?

(1) Please copy and paste the registration link in a brower or scan the wechat code to register and make the payment for each session.

(2) We will send the gotowebinar link of each session to your e-mail address at least one day before the class.

(3) Please click the link to set up the gotoweinar platform and check your system if it is your first time to use gotowebinar.

(4) Please make sure to attend each class at the pre-defined times.

重 要 通 知

(Important Notice)


If the number of attendees does not meet the minimum number, the organizer will have the right to postpone the classes, or cancel the classes.


If the classes are cancelled due to the organizer's causes, the organizer will reschedule the missed class, or make full refund to the attendee.


If the class can not run as planned due to Force Majeure,the organizer will not make any refund to the attendees.


In case you make the payment but miss the session or class, you will have the opportunity for one time to attend another session/class. No refund. Thanks for your understanding and support!


邮件:drugtimes@qq.com(请在主题栏注明"FDA training webinar" )

手机:+86 17811879657

For any questions, please contact us.

E-mail: drugtimes@qq.com (Please include "FDA training webinar" in the subject)

Mobile: +86 17811879657




Warmly welcome friends to attend!

Limited opportunities.

Please register asap. 

Thanks a lot!

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FDA法规研修班Session 1(5月11日开始)
2019-05-05 22:00
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