4月20日，我们一起系统学习FDA最新法规！Better understand FDA regulations!

原文始发于微信公众号（药时代）：4月20日，我们一起系统学习FDA最新法规！Better understand FDA regulations!

课程简介

4月20日，我们一起系统学习FDA最新法规！Better understand 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JanetFourman博士、GaryFourman博士主讲。

This series of training courses is co-organized byMinYue-Pharos Consulting, LLCandDrugTimes, presented by Dr. Janet Fourman and Dr. Gary Fourman, American experts with decades of experience in 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。

Section1:基础知识(12hours)

Section2:GxP’s(20hours)

Section3:质量(14hours)

Section4:生物药品(8hours)

Section5:基因疗法(6hours)

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.

Section1:Foundations(12hours)

Section2:GxP’s(20hours)

Section3:Quality(14hours)

Section4:Biologics(8hours)

Section5:GeneTherapies(6hours)

Through these studies, 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, 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！

Thedemoclasson2019-04-08wentverywell.Manythanksto~80friendsfortheirstrongsupport!

Jan Fourman，博士，PhD，EdD，MBA，MSRA。Fourman博士是一位资深法规事务注册专家，拥有25年的从业经验，曾在礼来公司负责美国及全球药品注册事务。她拥有普渡大学法规事务和质量法规硕士学位、普渡大学生物技术、创新和监管科学博士学位、西密歇根大学健康教育学博士学位，以及印第安纳大学MBA学位。Fourman博士在新药研发与注册领域拥有丰富经验，尤其擅长糖尿病/内分泌、癌症、神经、骨骼/肌肉/关节等方面的新药注册。Fourman博士还精通生物制剂、器械、体外诊断、药械组合及伴随诊断产品FDA法规及注册要求。Fourman博士曾受邀在多个国家教授美国FDA法规及药品注册事务课程。Fourman博士在几十年工作之余编写课程，撰稿出书，发表关于法规策略的文献综述与报道。Fourman博士为普渡大学法规事务研究生课程撰写教材并主讲，并为制药和医疗器械公司提供3-5天的实地培训。

Gary L. Fourman，DP，RPh，MBA，具有四十三年药品及医疗器械研发与质量体系管理经验。他早期参与了无线电不透明成像产品制造的一线工作，之后在FDA从事政府广泛质量监管与督察工作。他后来分别就职于Upjohn、辉瑞和礼来，从事产品开发、GMP体系建立和管理以及质量控制，长达33年。他是礼来的第一位质量倡导者奖得主。他的其它经验包括统计数据应用和计算机系统建立，以确保产品顺利注册和迅速上市。最近，他也在普渡大学担任兼职讲师。

岳新民女士，一位药械行业资深的国际法规策略与注册专家，具有25年世界顶尖医药、医疗器械、诊断试剂及咨询公司的实战和管理经验。她近15年任国际法规注册经理/总监职位，为礼来制药、贝克曼生命科学及PAREXEL公司在全世界100多个国家注册了300多种药品及医疗器械设备与试剂。新民来自中国长沙，持湖南农大兽医学院兽医学位、美国威斯康星大学免疫学硕士、美国药械法规专业证书(RAC）。她将科学理论、药械研发与质量法规管理有机结合并灵活运用，常与中国药监局（CFDA，现名NMPA）进行交流与探讨以加速新药和诊断产品在中国的注册与上市。新民也常被邀请在美国及其它国际会议上演讲及培训国际/亚洲/中国法规和注册策略。新民创立了”MinYue-PharosConsulting”(明月药械中美咨询），现为中美两国药械行业提供研发质量控制、临床试验、上市前注册申报及上市后法规管理咨询与服务。岳新民女士将针对中国和美国的法规要求分享实战与交流策略，并主持与协调教学课程。

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：Foundations

4月20日，我们一起系统学习FDA最新法规！Better understand FDA regulations!

Duration:12hoursin6classes

Fee:3000RMB/450USD

Content:

History of US Food, Drug and Cosmetic Laws (Jan)
Pharma Research Ethics – ICH, WHO (Jan)
Prescription Drug Product Submissions – New Chemical Entities, Breakthrough Therapy, Fast Track Review (Jan)
Generic versus Prescription Drugs (Jan)
Patents and Exclusivity (Jan)
Over-the-Counter (OTC) Nonprescription Drugs (Jan)

Classtime(BeijingTime):

2019-04-20Saturday8:00-10:00AM
2019-04-21Sunday8:00-10:00PM
2019-04-27Saturday8:00-10:00AM
2019-04-28Sunday8:00-10:00PM
2019-05-04Saturday8:00-10:00AM
2019-05-05Sunday8:00-10:00PM

RegistrationLink:

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

orscanregistrationwechatQRcode:

报名截止日期：2019-04-18星期四

Deadlineforregistration:2019-04-18Thursday

Session2：GxP’s

4月20日，我们一起系统学习FDA最新法规！Better understand FDA regulations!

Duration:20hoursin10classes

Fee:5000RMB/750USD

Content:

Nonclinical Studies of Drug Products – Toxicology, Pharmacodynamics, Pharmacokinetics (Jan)
Good Laboratory Practices (GLPs) (Jan)
Clinical Trials of Drug Products – Trial Phases 1 through 4 (Jan)
Good Clinical Practices (GCPs) (Jan)
Clinical Trials for Oncology (Jan)
Clinical Trials Design and Statistics (Jan)
Statistical Applications (Gary)
Chemistry, Manufacturing and Controls (Gary)
Good Manufacturing Practices (GMPs) (Gary)
Good Manufacturing Practices (GMPs) Sterile Products (Gary)

Classtime(BeijingTime):

2019-05-11Saturday8:00-10:00AM
2019-05-12Sunday8:00-10:00PM
2019-05-18Saturday8:00-10:00AM
2019-05-19Sunday8:00-10:00PM
2019-05-25Saturday8:00-10:00AM
2019-05-26Sunday8:00-10:00PM
2019-06-01Saturday8:00-10:00AM
2019-06-02Sunday8:00-10:00PM
2019-06-08Saturday8:00-10:00AM
2019-06-09Sunday8:00-10:00PM

RegistrationLink:

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

orscanregistrationwechatQRcode:

报名截止日期：2019-05-09星期四

Deadlineforregistration:2019-05-09Thursday

Session3：Quality

4月20日，我们一起系统学习FDA最新法规！Better understand FDA regulations!

Duration:14hoursin7classes

Fee:3500RMB/525USD

Content:

Quality Systems – ICH, ISO, Electronic Systems (Jan and Gary)
Post-approval Prescription Drug Submissions and Compliance (Jan)
Prescription Drug Labeling (Jan)
Pharmacovigilance – Patients, Manufacturing (Jan and Gary)
Risk Management (Jan)

Classtime(BeijingTime):

2019-06-15Saturday8:00-10:00AM
2019-06-16Sunday8:00-10:00PM
2019-06-22Saturday8:00-10:00AM
2019-06-23Sunday8:00-10:00PM
2019-06-29Saturday8:00-10:00AM
2019-06-30Sunday8:00-10:00PM
2019-07-06Saturday8:00-10:00AM

RegistrationLink:

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

orscanregistrationQRcode:

报名截止日期：2019-06-13星期四

Deadlineforregistration:2019-06-13Thursday

Session4：Biologics

4月20日，我们一起系统学习FDA最新法规！Better understand FDA regulations!

Duration:8hoursin4classes

Fee:2000RMB/300USD

Content:

Biologics Introduction and Submissions (Jan)
Biologics Clinical Testing (Jan)
Biologics Compliance (Jan)
Biosimilars (Jan)

Classtime(BeijingTime):

2019-07-07Sunday8:00-10:00PM
2019-07-13Saturday8:00-10:00AM
2019-07-14Sunday8:00-10:00PM
2019-07-20Saturday8:00-10:00AM

RegistrationLink:

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

orscanregistrationQRcode:

报名截止日期：2019-07-05星期五

Deadlineforregistration:2019-07-05Friday

Session5：GeneTherapies

4月20日，我们一起系统学习FDA最新法规！Better understand FDA regulations!

Duration:6hoursin3classes

Fee:1500RMB/225USD

Content:

Blood and Blood Products (Jan)
Products for Subpopulations –Pediatrics, Geriatrics, Rare Diseases (Jan)
Human Cell and Tissue Products (Jan)

Classtime(BeijingTime):

2019-07-21Sunday8:00-10:00PM
2019-07-27Saturday8:00-10:00AM
2019-07-28Sunday8:00-10:00PM

RegistrationLink:

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

orscanregistrationwechatQRcode:

报名截止日期：2019-07-19星期五

Deadlineforregistration:2019-07-19Friday

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。

Howtoregister?

(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！

Incaseyoumakethepaymentbutmissthesessionorclass,youwillhavetheopportunityforonetimetoattendanothersession/class.Norefund.Thanksforyourunderstandingandsupport!

（4）任何问题，敬请联系我们。

邮件：drugtimes@qq.com

（请在主题栏注明”FDA training webinar” ）

手机：+8617811879657

微信：27674131

For any questions, please contact us.

E-mail:drugtimes@qq.com

(Please include “FDA training webinar” in the subject)

Mobile:+8617811879657

Wechat:27674131