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

课程简介

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. Janet Fourman and Dr. Gary Fourman, American experts with decades of experience on US and global pharmaceuticals, medical devices, and IVD registrations. 

Dr. Janet Fourman and Dr. Gary Fourman

学时60小时，分5个session进行。通过学习，学员朋友们将对美国FDA的最新法规有系统深入的了解，可立即在医药研发工作中应用。本课程适合医药研发公司、生物技术公司研发主管、临床研发专家、大学法规事务专业讲师或学生、从事注册事务、临床监管、质量体系创建与管理等工作的专业人士。

完成课程学习的朋友将获得两位专家老师、主办方创始人签名的结业证书。

60 hours in 5 sessions. Through studies, friends will have a systematic and in-depth understanding of the latest FDA regulations, and can immediately apply to their pharmaceutical research and development work. This course is suitable for R&D professionals in pharmaceutical R&D companies, biotechnology companies, clinical trial organizations, and 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.

2019年4月8日星期一，早上9:15~10:15（北京时间），试听课成功举办。衷心感谢80位朋友们的支持！

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

现在，我们发布5个session的报名通知和报名链接。

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

Session 1

Duration: 12 hours in 6 classes

Fee: 3000 RMB / 450 USD

Content:

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

2. 2019-04-21    Sunday 8:00-10:00 PM

3. 2019-04-27 Saturday 8:00-10:00 AM

4. 2019-04-28    Sunday 8:00-10:00 PM

5. 2019-05-04 Saturday 8:00-10:00 AM

6. 2019-05-05    Sunday 8:00-10:00 PM

Registration Link:

https://www.bagevent.com/event/2556806

or scan registration wechat QR code:

报名截止日期：2019-04-18 星期四

Deadline for registration: 2019-04-18 Thursday

Session 2

Duration: 20 hours in 10 classes

Fee: 5000 RMB / 750 USD

Content:

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

2. 2019-05-12    Sunday 8:00-10:00 PM

3. 2019-05-18 Saturday 8:00-10:00 AM
   

4. 2019-05-19    Sunday 8:00-10:00 PM

5. 2019-05-25 Saturday 8:00-10:00 AM
   

6. 2019-05-26    Sunday 8:00-10:00 PM

7. 2019-06-01 Saturday 8:00-10:00 AM

8. 2019-06-02    Sunday 8:00-10:00 PM

9. 2019-06-08 Saturday 8:00-10:00 AM

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

Registration Link:

https://www.bagevent.com/event/2572341

or scan registration wechat QR code:

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

Content:

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

2. 2019-06-16    Sunday 8:00-10:00 PM

3. 2019-06-22 Saturday 8:00-10:00 AM
   

4. 2019-06-23    Sunday 8:00-10:00 PM

5. 2019-06-29 Saturday 8:00-10:00 AM
   

6. 2019-06-30    Sunday 8:00-10:00 PM

7. 2019-07-06 Saturday 8:00-10:00 AM

Registration Link:

https://www.bagevent.com/event/2572393

or scan registration QR code:

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

Content:

1. Biologics Introduction and Submissions (Jan)

2. Biologics Clinical Testing (Jan)

3. Biologics Compliance (Jan)

4. Biosimilars (Jan)

Class time (Beijing Time):

1. 2019-07-07    Sunday 8:00-10:00 PM

2. 2019-07-13 Saturday 8:00-10:00 AM

3. 2019-07-14    Sunday 8:00-10:00 PM

4. 2019-07-20 Saturday 8:00-10:00 AM

Registration Link:

https://www.bagevent.com/event/2572453

or scan registration QR code:

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

Content:

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. 2019-07-21    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

Registration Link:

https://www.bagevent.com/event/2572589

or scan registration wechat QR code:

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）

（1）如果报名人数没有达到开课最低人数要求，主办方有权利推迟开课或取消课程。

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

（2）如果因主办方的缘故取消课程，主办方将另行安排补课，或全额退款。

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.

（3）如果课程因不可抗力无法按预定计划进行，主办方无需退款。

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

（4）如果您注册但因故无法参加一节课或一个session，您有一次机会补课。恕不退款。敬请知悉谅解！

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!

（5）任何问题，敬请联系我们。

邮件：[e-mail]（请在主题栏注明"FDA training webinar" ）

手机：[phone]

For any questions, please contact us.

E-mail: [e-mail] (Please include "FDA training webinar" in the subject)

Mobile: [phone]

热烈欢迎朋友们参加！

名额有限，报名请从速！

衷心感谢！

Warmly welcome friends to attend!

Limited opportunities.

Please register asap. 

Thanks a lot!

聚焦新药研发，荟萃行业精华，分享交流合作，共筑健康天下！欢迎朋友们关注！谢谢！