【导读】为加强国际制药企业同行交流，国际制药项目管理协会（IPPM）联合加拿大PharmEng机构联合举办关于CMC撰写及FDA注册申请侧路培训班。
本次培训由PharmEng高级咨询顾问James Pierce先生主讲，课程一共2天，全英文授课、互动交流，实际案例讲解让您更直接了解CTD文档CMC部分的撰写以及FDA注册申请策略。
主办单位：IPPM、PharmEng（加拿大）
承办单位：天津凯博思科技有限公司
媒体支持：蒲公英
课程时间：2017年7月14-15日
课程地点：上海（具体地点报名后定向通知）
课程介绍：
本课程学习新药及仿制药申请CMC（中化学、制造和控制部分）的撰写；了解FDA注册申请策略，获取分析方法的验证/确认，稳定性考察以及质量源于设计的相关知识；学习并理解药品主文件在药品申请中的应用；掌握仿制药以及新药的在申请要求上的差异并设计相应的策略；获取跟监管部门沟通的技巧。
课程大纲：
1）CTD 模块2.3 （质量总体摘要）-写作技巧以及内容的协调
2）CTD 模块3 - 协作技巧以及监管部门的期望
3）药品主文件在申请中的作用
4）GMP支持性文件
5）决定药品有效期的稳定性考察
6）分析方法的验证 /确认
7）原料药与成品的标准
8）质量源于设计于CMC的关系
9）仿制药和原研药的CMC部分撰写差异
10）药品申请策略差异比较：仿制药和原研药
11）药品补充申请的策略
12）如何回应药品监管部门
13）和监管部门实现有效沟通的技巧
14）案例分析（基于学员递交的问题）
James Pierce讲师介绍：
James Pierce是PharmEng公司的资深顾问。具有24年的在生物药以及化药领域从事药事管理的经验。此前任职于多个跨过药企如赛诺菲，安进，勃林格殷格翰以及葛兰素史克的工作，参与药品研发，质量保证，工厂运行以及药事管理等工作。他曾负责生物制剂，化药，保健品以及医疗器械等不同产品的上市以及生物制剂及化药的临床研究申请。此外，James具有出色的和药监部门谈判的技巧。在申请递交的各个阶段如申请前会议，申请评审中的谈判都能和药品监管部分进行有效的沟通。还曾作为行业代表和监管部门谈判。James目前还是加拿大圭尔夫大学，新加坡国立大学，以及非盈利组织加拿大制药科技协会的客座讲师。
课程报名：
课程费：4000元/人（含会务费、资料费、茶歇、午餐）
IPPM企业会员和个人会员：3200元／人
加入IPPM会员咨询：[email protected]
均可开具发票
联系方式：
联系人：夏老师 手机：13764588378
盛老师 手机：13761638398
微 信：ak0369 邮箱：[email protected]
汇款账号：
账户名称：天津凯博思科技有限公司
银行名称：中国工商银行天津市黄纬路支行
单位账号：0302 0475 0930 0049778
附件一：参会报名表
关于CMC撰写及FDA注册申请策略培训培训
报名回执表
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此报名表请注明通讯地址、联系电话、手机号码 咨询电话：夏老师 13764588378 盛老师 13761638398（上海） 邮 箱： [email protected]
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附件:英文版课程大纲介绍
Objective
Tolearn how to prepare CMC in CDT format for NDA/ANDA submission; acquire theknowledge of method validation/ verification, stability programs s and qualityby design; learn and understand the use of DMF; ability to strategizesubmissions for Generics and Branded; gain the tips of successfulcommunications with Health Authorities.
Description
Thecourse will prepare the attendees with the basic knowledge of writing CMC （Module 2.3 QualityOverall Summary and Module 3）part ofthe CTD. It will emphasize the requirements related to drug substance startingmaterials, drug substance and drug product specifications, comparability,impurities, stability, and pharmaceutical development reports. It will also discuss the use of Drug MasterFiles (DMF) in preparation of filing. The course will discuss in-depth of CMCtopics of Analytical Method Validation / Verification, Quality by Design andCMC as well as Stability Programs. The course provides the principles andtechniques involved in strategizing submission for Branded verses Generics, howto use rolling and combined submissions as well as how to group post-approvalCMC variation submissions. The course will also cover how to response andinteract with Health Authorities and will provide tips for successful communications.
CourseOutline
1）CTDModule 2.3 (Quality Overall Summary) – Writing approach and contentharmonization
2）CTDModule 3 (Quality Section) --- Writing approach & Agency review expectations
3）Use ofDrug Master Files (DMF) as a tool in file preparation
4）GMPSupport Documents
5）Stability Programsfor Determining Product Shelf Life
6）Analytical MethodValidation / Verification
7）API and DrugProduct Specifications
8）Quality by Designand CMC
9）CMC writing forGeneric/Bio-similars verses Innovative
10）SubmissionStrategy: Branded verses Generics
11）Post-approval CMCvariation submission
12）Health Authoritiesqueries and How to Manage Response
13）Tips in SuccessfulInteraction with Health Authorities
14）Case Studies(obtained from course questionnaires)
TrainerProfile
James Pierce is currently a Regulatory Affairs Professional with over 24years of experience in the biological and pharmaceutical industry . Beforeholding the position as a senior consultant at PharmEng, he worked for some of themost recognized multinational companies (Sanofi, Amgen, Boehringer Ingelheimand GSK). Throughout his 24 years ofexperience, Mr. Pierce has worked in Research and Development, Quality Operations, Industrial Operations andRegulatory Affairs. He has beenresponsible for many different products (biologics, chemical entities, naturalhealth and Medical Device ) in commercial as well as products (biologic andchemical entities) in clinical development (CTAs). In addition, Mr. Pierce has demonstrated excellentdiplomacy and negotiating skills with Regulatory Authorities by successfullybeing involved in pre-filing meetings, negotiations during drug reviews,participation in on-site evaluations and industry panels. Mr. Pierce is alsoteaching certified programs at Guelph Humber University, National University ofSingapore and training programs for the Pharmaceutical Sciences Group (PSG).
