【药明康德仿制药一致性评价网络研讨会】演讲资料，视频链接

原文始发于微信公众号（药时代）：【药明康德仿制药一致性评价网络研讨会】演讲资料，视频链接

3月以来，国务院与CFDA连发与仿制药相关的通知意见与指导原则，仿制药一致性评价工作已经是开弓没有回头箭，各家药企都积极应对，主动响应政策，占领先机。作为国内最大的医药外包服务提供商，药明康德于2016年4月6日（周三） 13:00-17:00举办了“药明康德仿制药一致性评价网络研讨会”。多位专家通过对法规的解读，结合自身多年的项目经验，分享了仿药一致性评价各环节的技术要点。本活动旨在给仿药一致性评价研究参与单位提供一个平台，以便交流讨论如何更好地按照CFDA和美国FDA的要求和指导思想开展仿制药一致性评价。研讨会得到了业界朋友们的广泛关注和积极参与。

欢迎点击下方的【阅读原文】欣赏研讨会的录像！或使用以下链接。

http://ltd.wuxiapptec.com.cn/video-2016-04-06/

同时和朋友们分享药明康德制剂部Rajendrakumar主任的演讲资料。

【药明康德仿制药一致性评价网络研讨会】演讲资料，视频链接

Rajendrakumar Kale, Ph.D (Tech)

Rajendrakumar是一位印度籍制药研究员和专业技术顾问。他具备专业的业务知识和能力和长达九年的多家国际制药公司工作经历。

Rajendrakumar为International Controlled Release Society’s (CRS)摘要评审委员会的提名委员，发表多篇专业论文，并有一项美国专利申请，同时也是Indian Journal of Pharmaceutical Sciences杂志的评审专家。

Rajendrakumar在固体口服制剂方面具有丰富的新药研发经验，现任职于一家提供国内外药物研发综合服务的国际领军研发外包服务企业—–上海药明康德新药开发有限公司。

Brief Biography

Rajendrakumar Kale, Ph.D (Tech)

Rajendrakumar Kale is an Indian born pharmaceutical scientist and technical consultant. Over past 9 years he has been working in a wide variety of professional capacities with pharmaceutical organizations across cultures. He earned his Ph.D in 2007 through University of Mumbai’s (India) Ph.D (Tech) programme.

Rajendrakumar is the nominated member of International Controlled Release Society’s (CRS) Abstract Review Committee. He is honorary expert reviewer for ‘Indian Journal of Pharmaceutical Sciences’. He has several international research publications and one US Patent Application (provisional) to his credit. He has presented his research work in many national and international conferences.

During industry career, Rajendrakumar has gained ample amount of experience in generic dosage form development in the segment of solid orals for regulated markets. Currently Rajendrakumar is working with WuXi AppTec (Shanghai) Co. Ltd, a leading contract research organization dealing with integrated services of drug development ranging from IND filing to NDA (and NDF) submission projects for worldwide big and small Pharma companies.

【药明康德仿制药一致性评价网络研讨会】演讲资料，视频链接