Description

I am writing on behalf of Indian Pharmaceutical Association (IPA). We would be pleased to welcome you as the speaker to attend Asia Pacific Pharmaceutical Science Summit ForumAPPSFon Jan. 9-10, 2019 in Shanghai, China and give a 40-minute talk on: 1. New Drug Development Pathways in China 2. Generic Drugs: Research, Development and Regulatory Strategy Visions 3. Quality by Design -Concept and Implementation 4. Analytical Application and Biosimilar Introduction. We have watched your interview on the Internet and read your articles, and we would like to meet you and learn more about how you lead the pharmaceutical industry as well as the market to the road of innovation.

It is an honor and privilege to invite you to participate in our forum. We believe that your topic to pharmaceutics awareness is unparalleled, and are looking forward to hearing you speak on the forum. We will cover your expenses incurred during the conference for——travel and accommodation.

Thank you for considering our invitation. I hope to receive a positive reply from you before 11:59 p.m. on Nov. 9, 2018. If you have any questions, I can be reached anytime at yangchao@sjbmcc.com.

Kind regards,

Yours sincerely,

 Indian Pharmaceutical Association (IPA)

Organizing Committee of Asia Pacific Pharmaceutical Science Summit ForumAPPSF

Time:           Jan. 9-10, 2019

Venue:          Sheraton Shanghai Hongkou Hotel

Host:           Indian Pharmaceutical Association (IPA)

                SHENGJIE(Shanghai) Business Management & Consulting Co., Ltd

Co-organizers:  Pharmacy Council of India (PCI)

Director:        Chamber of Informatic Industry Commerce, Shanghai Federation of Industry and Commerce (SFIC)

Supporters:     Health Branch of Shanghai Federation of Industry and Commerce

ACPI KSPOR

Acharya Institutes

JSS Academy of Higher Education & Research

Media Partners: People.com.cn, Xinhua Net, The Paper, Eastday, Tencent, DXY, PHARMCUBE, Yaozhi, PharmFuture etc.

Forum Introduction: Asia-pacific Alliance, To improve Health Care Industry!

Domestic pharmaceutical companies face serious challenges now.

Join APPSF for the next breakthrough.

On Innovate Drugs

The current size of Chinese anti-tumor market is about 140 billion yuan. One third of the market is covered by the imported drugs. Drugs with the best curative effect are mostly imported. Although China has become the second largest medical and pharmaceutical market in the world, its proportion of innovative drugs with independent intellectual property rights is only 18%, far below the level of the United States, Europe and Japan.

On Generic Drugs

The global generic drugs market was valued at around US$ 244.5 Billion in 2017, growing at a compound annual growth rate (CAGR) of around 8% during 2010-2017 and Is expected to reach approximately USD 380.60 billion by 2021, expected growing at a CAGR of around 10.8 % between 2016 and 2021. FDA’s 2018 Proposal to Harmonize Standards for Generic Drugs, with such initiatives from Global regulatory bodies, propels the future of producing generic drug and makes the Generic Drug industry a high potential market and reason for generating more revenue for generic drugs Pharmaceutical industry. Thus, the current conference focuses on providing information to understand current global regulatory requirement for generic drug development and making your success path easy for contribution for development of quality medicine and treatment in cost effective way.

On QbD

Quality by Design (QbD) continues to be a hot topic across the life science industries, and as evidenced by the widespread adoption of QbD among manufacturers, there is no question about its benefits.   As the pharma sector moves to implement pharmaceutical QbD, regulatory bodies such as the FDA work provide a common understanding of key concepts, terminology and expectations. This conference focuses on reviewing the current understanding of concepts of pharmaceutical QbD and its implementation.

On Biosimilar:

Biosimilars are often confused with generic drugs—but they are not the same. Unlike generics, the FDA requires a biosimilar to be highly similar, but not identical to the existing biologic medicine, which is referred to as a "reference product”. Biopharmaceuticals accounted for nearly 25% of the global pharmaceutical market revenues from marketed drugs (~$1,100 billion) in 2016. To add to this, the patent expiry of the leading 10 biologic drugs represents a massive $70 billion opportunity for pharma companies over the period 2015 - 2020. Please join APPSF to learn more about the future game changer – Biosimilar.

We look forward to having professionals from related industries worldwide to attend this Asia Pacific Pharmaceutical Science Summit ForumAPPSF. With the industry insight and problem-oriented strategy, we will lead the pharmaceutical industry and market to the road of innovation. It would be great to have this forum in January. Let’s create and develop together.

Schedule

Jan.9  Wednesday

08:30-09:00

Admission

09:00-12:30

New Drug Development Pathways in China

(Opening Ceremony)

12:30-13:30

Lunch

13:30-16:40

Generic Drugs: Research, Development and Regulatory Strategy Visions

16:40-17:00

Appointment Ceremony for Honorary President and Advisory panel

Jan.10  Thursday

08:30-09:00

Entrance

09:00-12:30

Quality by Design - Concept and Implementation

12:30-13:30

Lunch

13:30-17:00

Analytical Application and Biosimilar Introduction

 

Agenda

 Day 1

New Drug Development Pathways in China

 (Opening Ceremony)

09:00-12:30 on Jan.9  The Banquet Hall on the Third Floor

Host speaker: Mr. Haihong Jin, Secretary-General, Chamber of Informatic Industry Commerce

08:30-09:00

Admission

09:00-09:10

Leader’s Oration

Dr. B Suresh, President, Pharmacy Council of India

Mr. Haihong Jin, Secretary-General, Chamber of Informatic Industry Commerce

09:10-09:50

Importance of Pharmacovigilance in Cancer Therapy

Dr. B Suresh, President, Pharmacy Council of India

09:50-10:30

Breaking the cultural barrier between India and China to improve the pharmaceutical industry

Dr. T. V. Narayana, President, Indian Pharmaceutical Association

10:30-11:10

China Drug Development Process - New Regulatory Reforms to Overcome the Barriers.

Dr. Bill Wei, Founder and CEO

Innovaco Pharmarceutical Inc., China

11:10-11:50

The Market Authorization Holder SystemMAH-Detail Overview

Mei Hao, VP, Quality Assurance, STA, China Draft

11:50-12:30

Safety of Clinical Treatment Efficacy Based on PD-1/L1 or Pharmacovigilance and its importance :Anticancer Application

Anantha Naik, Director, Amity Institute of Pharmacy, Gwalior, India.

12:30-13:30

Lunch

Generic Drugs: Research, Development and Regulatory Strategy Visions

13:30-17:00 on Jan.9  The Banquet Hall on the Third Floor

Host speaker: Dr. B Suresh, President, Pharmacy Council of India

13:30-14:30

Regulatory Challenge and Approach for Global Generic Drug Develop-ment: Understanding Current Guidelines and Strategy  (China, US, UK, Japan, Australia,  and Canada)

Dr. Raghunandan Venkatram Huralihalli, Founder of Chief Technical Consultant, RC2 Pharma Solutions, India.

14:30-15:20

Challenges and Opportunities of Generic Drugs in Chinese Market: Current Regulatory Overview

CNDADraft

15:20-16:00

Development of Oral Tablets – A Design Strategy

Harish K Jain, Director, Embiotic Laboratories (P) LTD

Secretary, Karanataka (Provincial) Drug Manufacturing Association.

16:00-16:40

Electronic Regulatory Submissions in eCTD Format – Understanding and Implementation.

Indian Pharmaceutical Association

16:40-17:00

Appointment Ceremony for Honorary President and Advisory Panel

Organizer

 Day 2

Quality by Design - Concept and Implementation

09:00-12:30 on Jan.10  The Banquet Hall on the Third Floor

Host speaker/Chairperson:  Dr. Premnath Shenoy

08:30-09:00

Entrance

09:00-10:00

Importance of QbD and its Approach in Pharmaceutical Industry - Regulatory Overview (USFDA, EU-EMEA, PMDA & ICH)

Dr. Bhupinder Singh Bhoop, Professor, University Institute of Pharmaceutical Sciences, Panjab, Chandigarh, India

10:00-10:50

Application and Implementation of QbD Design in Generic Drug Development - Solid and Semi Solid Overview

Dr. Bhupinder Singh Bhoop, Professor, University Institute of Pharmaceutical Sciences, Panjab, Chandigarh, India (Team)

10:50-11:40

Application of QbD in Analytical Research and Development

Dr. Bhupinder Singh Bhoop, Professor, University Institute of Pharmaceutical Sciences, Panjab, Chandigarh, India (Team)

11:40-12:30

Terminology, Statical

 tools and Models used for implementation of QbD

Dr Shivang Chaudhary, Chief Knowledge Officer (CKO) & Global Head Quality by Design (Formulation & Process Development), QbD Expert™ Ahmedabad, India.

12:30-13:00

Lunch

Analytical Application and Biosimilar Introduction

13:30-17:00 on Jan.10  The Banquet Hall on the Third Floor

Host speaker: Harish K Jain

13:30-14:10

Recent Developments and Approaches in Pharmaceutical Analysis:  Method Development, Qualification and Validation

WuXi AppTecDraft

14:10-14:50

Global Regulatory Challenges and Consideration for impurity characterization for: Heavy Metals, Residual solvents and genotoxic.

Pharmacy Council of India

14:50-15:30

Introduction to Bio analytics and Advances in Bio analytics

Dr. V. V. Ramireddy,

Global Director and Technical Operations,

National Chromatography Inco. (Bangalore and USA)

15:30-16:10

Role and Importance of International Pharmacopoeia and their control on Pharmaceutical Preparation.

USPDraft

16:10-17:00

Biosimilar Medicine: Global Scenario and Race in China (Future Game Changer).

Dr. Premnath Shenoy, Regulatory Director, AstraZeneca.

More guest speakers are coming in, and the final schedule is subject to the actual arrangement of the conference.

Schedule

时间:2019年1月9-10日

地点:上海虹口三至喜来登酒店

1月9日 星期三

08:30-09:00

签到入场 & 暖场视频

09:00-12:30

中国新药的研发路线图论坛(论坛开幕)

12:30-13:30

午餐

13:30-16:40

仿制药产业战略前瞻——研发与监管论坛

16:40-17:00

大会荣誉主席及顾问团聘任仪式

1月10日 星期四

08:30-09:00

入场

09:00-12:30

QbD——概念与应用论坛

12:30-13:30

午餐

13:30-17:00

生物类似药与分析应用论坛

论坛议程

 第一天

中国新药的研发路线图

(开幕典礼)

1月9日 09:00-12:30  3楼宴会厅

主持人:金海虹(上海市工商业联合会信息产业商会秘书长)

08:30-09:00

签到入场 & 暖场视频

09:00-09:10

领导致辞

Dr. B Suresh(印度制药委员会【PCI】主席)

金海虹(上海市工商业联合会信息产业商会秘书长)

09:10-09:50

药物警戒在肿瘤治疗中的重要性

Dr. B Suresh(印度制药委员会【PCI】主席)

印度药典委员会科学机构主席

印度J.S.S. University校长

09:50-10:30

打破文化隔阂,中印携手共同发展制药产业

Dr. T. V. Narayana(印度制药协会【IPA】主席)

10:30-11:10

中国药物研发进展—新的监管改革来攻克壁垒

Dr. Bill Wei

Innovaco Pharmarceutical Inc.

创始人及首席执行官

11:10-11:50

MAH药品上市许可持有人制度详细概述

郝玫(药明康德子公司合全药业全球质量副总裁)【拟】

11:50-12:30

抗肿瘤应用:基于PD-1/L1临床治疗的安全性与药物警戒的重要性

Dr. Anantha Naik Nagappa(印度阿米蒂医药研究所制药总监)

12:30-13:30

午餐

 仿制药产业战略前瞻——研发与监管

1月9日 13:30-17:00  3楼宴会厅

主持人:Dr. B Suresh(印度制药委员会【PCI】主席)

13:30-14:30

全球仿制药市场发展与监管挑战:最新指导方针和战略解析(中国、美国、英国、日本、澳大利亚和加拿大)

Dr. Raghunandan Venkatram Huralihalli

(RC2 Pharma Solution首席技术顾问创始人)

14:30-15:20

如何面对印度仿制药在中国市场面临的机遇和挑战:最新监管概述

国家药品监督管理局【拟】

15:20-16:00

口服片剂的开发过程——设计策略

Harish K Jain

Embiotic Laboratories (P) LTD.药物研发总监

Karanataka (Provincial) Drug Manufacturing Association.秘书长

16:00-16:40

使用eCTD格式进行电子监管申报——理解与应用

印度制药协会

16:40-17:00

大会荣誉主席及顾问团聘任仪式

大会主办方代表

 第二天

QbD——概念与应用

1月10日 09:00-12:30  3楼宴会厅

主持人:Dr. Premnath Shenoy

08:30-09:00

入场

09:00-10:00

QbD在制药业中的重要性、应用方法及监管概述(USFDA、EU-EMEA、PMDA和ICH)

Dr. Bhupinder Singh Bhoop

(印度潘加布大学药学研究所教授及其团队)

10:00-10:50

QbD设计在仿制药开发阶段中的应用与实施

Dr. Bhupinder Singh Bhoop

(印度潘加布大学药学研究所教授及其团队)

10:50-11:40

QbD在分析研究开发中的应用

Dr. Bhupinder Singh Bhoop

(印度潘加布大学药学研究所教授及其团队)

11:40-12:30

用于实现QbD的工具和模型

Dr. Shivang Chaudhary

QbD-Expert™

首席知识官兼全球QbD总监 (制定与流程开发)

12:30-13:30

午餐

生物类似药与分析应用

1月10日 13:30-17:00  3楼宴会厅

主持人:Harish K Jain

13:30-14:10

药物分析领域,开发方法,获取资格与有效性的最新进展

药明康德【拟】

14:10-14:50

世界范围内对重金属与杂质的监管与思考: 重金属,残留溶剂和基因毒性

印度制药委员会

14:50-15:30

生物分析学简介与生物分析学的最新进展

Dr. V.V.Ramireddy

National Chromatography Inco.

全球总监 & 技术运营(印度班加罗尔及美国)

15:30-16:10

国际药典的作用与重要性及其对药物生产的调控

USP【拟】

16:10-17:00

生物类似药:全球前景与中国竞赛(未来的规则改变者)

Dr. Premnath Shenoy (阿斯利康监管总监)

更多嘉宾陆续加入中,最终日程以大会现场实际安排为准。

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Registration

Corporation

** Includes: Delegate badge, Attend the whole Conference, Simultaneous interpretation during conference, Business tea breaks, Buffet Lunches, One copy of Conference Proceedings. Traveling and accommodation expenses are excluded.

Committee

Indian Pharmaceutical Association (IPA)
 

The Indian Pharmaceutical Association (IPA) founded in 1939, is the oldest premier association of pharmaceutical professionals in India, with a member base of over 13,000, spread across the length and breadth of the nation. IPA operates in India through 20 state branches and more than 46 local branches. The members represent various facets of pharmaceutical profession viz., industry, regulatory, community and hospital pharmacy practices and education.

As a member of the Drug Technical Advisory Board, India, IPA is actively involved in advising the government on matters of professional importance. IPA is affiliated with international pharma associations like FIP, FAPA, CPA, AAPS, AAiPS and is working with international bodies such as WHO and WHPA for carrying out various collaborative professional activities that include organizing training programmes for professionals from industry, academics, regulatory and practice.

IPA makes representations to the authorities on matters of professional interest and works constantly towards upgrading the standards of pharmacy professional services offered by the pharmacists. IPA’s major objective is to position pharmacists as one of the important healthcare providers in our country.

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Contact information

  • Dr.Johnny Yang
  • yangchao@appsf.org.cn
  • +86 17091411592