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Schedule
2019-09-24
2019-09-25
2019-09-24
09:00 -12:10
Main Forum
2019-09-24
09:00-09:15

Welcome Speech

Speaker
Guangcheng Pan
Executive President, China Pharmaceutical Industry Association
2019-09-24
09:15-10:00

The Latest Policy and Development Trend of Medical Reform

Speaker
Ziran Zhang
VP, China Pharmaceutical Industry Association
2019-09-24
10:00-10:45

The Impact of the STAR Market on the Bio-Pharmaceutical Industry

Speaker
Wenming Li
Partner in HejunConsulting
2019-09-24
10:45-11:15

Tea Break

2019-09-24
11:15-12:00

Panel Discussion: Balancing the Price and Market under 4+7

Speaker
Ziran Zhang
VP, China Pharmaceutical Industry Association
Xiaodan Guo
Secretary General, CCCMHPIE
Wenming Li
Partner in HejunConsulting
2019-09-24
13:30 -17:20
Forum 1: Innovative & Modified Preparations
2019-09-24
13:30-14:10

Development Strategy for Long-released Injectable Preparations

Speaker
Kaoxiang Sun
Vice President, Formulation Research, R&D Center, Luye Pharmacy Group
2019-09-24
14:10-14:50

Research and Application of Long-acting Nanocrystalline Injection

Speaker
Zhong Liu
the Deputy General Manager of Lunan Pharmaceutical Group and the Director of the Institute of Biopharmaceuticals
2019-09-24
14:50-15:20

Tea Break

2019-09-24
15:20-16:00

Prospects of Drugs for International Market Development

Speaker
Xiaodan Guo
Secretary General, CCCMHPIE
2019-09-24
16:00-16:40

Panel Discussion: Innovative and Improved Formulation R&D and Patent Strategy

Speaker
Xavier Yin
SBZL Intellectual Property
Kaoxiang Sun
Vice President, Formulation Research, R&D Center, Luye Pharmacy Group
Zhong Liu
the Deputy General Manager of Lunan Pharmaceutical Group and the Director of the Institute of Biopharmaceuticals
Xiaodan Guo
Secretary General, CCCMHPIE
2019-09-24
13:30 -17:20
Forum 2: CMC & Regulation Affairs
2019-09-24
13:30-14:10

Improve the Related Review System to Ensure the Quality and Safety of Drugs

Speaker
Huimin Sun
Director of Packaging Materials and Pharmaceutical Excipients Certification Institute, China Food and Drug Control Institute
2019-09-24
14:10-14:50

Study on the Selection and Stability of Drug Polymorphs

Speaker
Deepak Hedge
Senior Vice President, CMC at EOC Pharma
2019-09-24
14:50-15:30

Analysis Control and Risk Assessment of Impurities in ICH M7

Speaker
Jianhua Ge
VP of Institute of KPC Pharmaceuticals
2019-09-24
15:30-16:00

Tea Break

2019-09-24
13:30 -17:20
Forum 3: Consistency Evaluation
2019-09-24
13:30-14:10

Complex Injection Consistency Evaluation Research and Case Study

Speaker
Wenjian Cai
Head of Formulation Department, Guangdong Jiabo Pharmaceutical Co. Ltd
2019-09-24
14:10-14:50

Injection Development Ideas and High-risk Control

Speaker
Frank Fan
ICAS Pharma (Shanghai) Co., Ltd.
2019-09-24
14:50-15:30

Interpretation of ICH M10: Bioanalytical Method Validation Final endorsed Business Plan

Speaker
Fuqing Dai
Vice general manager of Nanjing Huawe Medicine Technology Development co., LTD.
2019-09-24
16:00-16:40

Tea Break

2019-09-25
09:00 -17:20
Forum 1: Innovative & Modified Preparations
2019-09-25
09:00-09:40

Factors and Process of Pellets Formulation

Speaker
Ying Ye
Chairman of LP Pharma
2019-09-25
09:40-10:20

The Application of Oral Sustained-Release Drug Delivery System in Neurological Dugs

Speaker
Dezhi ZHU
Formulation Director, COSCI MED-TECH CO.,LTD.
2019-09-25
10:20-10:50

Tea Break

2019-09-25
10:50-11:30

Difficulties in Analysis of the Pre-formulation Design of Oral Sustained-release Preparations

Speaker
Gilbert Wen
CEO at Overseas Pharmaceuticals Ltd
2019-09-25
11:30-12:10

Practical Considerations for the Development of New Drug Products via 505b(2) NDA Pathway

Speaker
Hongchun Qiu
Vice President, Pharmaceutical Product Development at Prinbury BioPharm Co.
2019-09-25
12:10-13:30

Luncheon

2019-09-25
13:30-14:10

Panel Discussion: How to Improve the Stability of Sustained-release Injection?

Speaker
Ying Ye
Chairman of LP Pharma
Gilbert Wen
CEO at Overseas Pharmaceuticals Ltd
Dezhi ZHU
Formulation Director, COSCI MED-TECH CO.,LTD.
Hongchun Qiu
Vice President, Pharmaceutical Product Development at Prinbury BioPharm Co.
2019-09-25
14:10-14:50

R&D and Recent Progress of Pharmaceutical Preparations

Speaker
Shengyan Huang
Researcher, Shanghai Institute of Pharmaceutical Industry
2019-09-25
14:50-15:20

Tea Break

2019-09-25
15:20-15:35

BioBAY- the First Choice for Innovative Biomedical Industrialization

Speaker
Yueyi Tao
Manager, BioBAY-Changshu
2019-09-25
15:35-16:10

Treatment Dilemma and New Drug Innovation for Central Nervous System Diseases

Speaker
Anchen Guo
Director, Beijing Tiantan Hospital
2019-09-25
16:10-16:50

Strategy and Consideration of Formulation about Novel Drugs on Different Stages

Speaker
Hongyan Ma
Operation VP of Shanghai Aucta
2019-09-25
09:00 -17:20
Forum 2: CMC & Regulation Affairs
2019-09-25
09:00-09:45

Deep Interpretation of the Current Situation and Prospect of eCTD Implementation in China

Speaker
Richard Que
Publishing Team Lead (Emerging Market, CMC and Japan), Worldwide Regulatory Operations, Pfizer
2019-09-25
09:45-10:30

Strategies of Registration with eCTD

Speaker
Winnie Yang
the Head of Life Sciences Business Process Services (LS BPS) China Operations at DXC Technology
2019-09-25
10:30-11:00

Tea Break

2019-09-25
11:00-11:45

Panel Discussion: Common Issues in the Submission of Registration Applications with eCTD

Speaker
Handsome Ji
China Publishing Hub Lead, Pfizer
Winnie Yang
the Head of Life Sciences Business Process Services (LS BPS) China Operations at DXC Technology
Richard Que
Publishing Team Lead (Emerging Market, CMC and Japan), Worldwide Regulatory Operations, Pfizer
2019-09-25
11:45-13:30

Luncheon

2019-09-25
13:30-14:10

Panel Discussion：Common Problems and Strategies of the Registration in Domestic Regulations

Speaker
Zhengping Wu
Vice President at Hutchinson MediPharma
Jimmy Zeng
General Manager of Zhendong Group International Department
Na Xu
Director of Global Regulatory Affairs, WuXi AppTec
2019-09-25
14:10-14:50

Declaration and Capacity Building under MAH

Speaker
Zhengping Wu
Vice President at Hutchinson MediPharma
2019-09-25
14:50-15:30

Research and Development Strategy of Generics ANDA in US

Speaker
Jimmy Zeng
General Manager of Zhendong Group International Department
2019-09-25
15:30-16:00

Tea Break

2019-09-25
09:00 -17:20
Forum 3: Consistency Evaluation
2019-09-25
09:00-09:40

Consistency Evaluation and Technical Guidance of Sustained-release Preparations and Reference Preparations

Speaker
Mindi Xu
Deputy Director, NIFDC
2019-09-25
09:40-10:20

Thoughts on the Consistency Evaluation of Generics Scientifically

Speaker
Shaohong Jin
Chief expert on chemical drug analysis in NIFDC
2019-09-25
10:20-10:50

Tea Break

2019-09-25
10:50-11:30

Mistakes in BE Trial of Generic Drugs

Speaker
Dongsheng Ouyang
Chairman of Changsha Duzheng biotechnology Co., Ltd.
2019-09-25
11:30-12:10

Panel Discussion: Consistency Evaluation of Quality and Efficiency of Poorly Soluble Preparation

Speaker
Jianjun Guo
General Manager/Test Facility Manager of EverPro Medical Co., Ltd.
Mindi Xu
Deputy Director, NIFDC
Shaohong Jin
Chief expert on chemical drug analysis in NIFDC
Dongsheng Ouyang
Chairman of Changsha Duzheng biotechnology Co., Ltd.
Yali Liu
GCP Expert, Professor of the First Affiliated Hospital of Shantou University Medical College
2019-09-25
12:10-13:30

Luncheon

2019-09-25
13:30-14:10

Bioequivalence Test and Consistency Evaluation of High Variation Drugs

Speaker
Yali Liu
GCP Expert, Professor of the First Affiliated Hospital of Shantou University Medical College
2019-09-25
14:10-14:50

Bioequivalence Research and Technical Challenges in Inhalations

Speaker
Yue Tang
Associate Professor, China Pharmaceutical University, visiting scholar at Cornell University
2019-09-25
14:50-15:30

Analysis of the Main Points of Evaluation of Internal and External Consistency of Slow Control Agent

Speaker
Li Zeng
CEO of Jing Medicine
2019-09-25
15:30-16:00

Tea Break

Welcome Speech

Guangcheng Pan
Executive President, China Pharmaceutical Industry Association

The Latest Policy and Development Trend of Medical Reform

Ziran Zhang
VP, China Pharmaceutical Industry Association

The Impact of the STAR Market on the Bio-Pharmaceutical Industry

Wenming Li
Partner in HejunConsulting

Tea Break

Panel Discussion: Balancing the Price and Market under 4+7

Ziran Zhang
VP, China Pharmaceutical Industry Association
Xiaodan Guo
Secretary General, CCCMHPIE
Guo Xiaodan received her Master degree in Pharmacy Administration from Shenyang Pharmaceutical University, she has more than 10 years working experience in the pharmaceutical industry. She is active in formulating government trade and regulatory policies, strengthen communications between China and abroad, government and companies, proposing lots of suggestion during the revision of drug administration law, solving problems such as EU No. 62 directive, Drug manufacturing consignment, CoPP, Drug HS code and so on. She organized many industry exchange dialogues and match-making programs with EU, US, Japan, Korea, India, Africa regulatory agencies and companies. Ms Guo specializes in international market access and regulatory strategy, healthcare trade and opportunities consultancy, multi-bilateral healthcare cooperation research， she has rich experience in policy and industry coordination. She takes the lead in many ministry-sponsored projects including drug distribution system research, emerging pharmaceutical market development, China’s pharmaceutical import and export regulation system, the globalization of Chinese healthcare industry etc. She published over 60 articles and thesis on newspapers and magazines. Ms Guo is also responsible for the China-India, China-Japan, China-Korea bilateral healthcare cooperation under government framework.
Wenming Li
Partner in HejunConsulting

Development Strategy for Long-released Injectable Preparations

Kaoxiang Sun
Vice President, Formulation Research, R&D Center, Luye Pharmacy Group

Research and Application of Long-acting Nanocrystalline Injection

Zhong Liu
the Deputy General Manager of Lunan Pharmaceutical Group and the Director of the Institute of Biopharmaceuticals

Tea Break

Prospects of Drugs for International Market Development

Xiaodan Guo
Secretary General, CCCMHPIE
Guo Xiaodan received her Master degree in Pharmacy Administration from Shenyang Pharmaceutical University, she has more than 10 years working experience in the pharmaceutical industry. She is active in formulating government trade and regulatory policies, strengthen communications between China and abroad, government and companies, proposing lots of suggestion during the revision of drug administration law, solving problems such as EU No. 62 directive, Drug manufacturing consignment, CoPP, Drug HS code and so on. She organized many industry exchange dialogues and match-making programs with EU, US, Japan, Korea, India, Africa regulatory agencies and companies. Ms Guo specializes in international market access and regulatory strategy, healthcare trade and opportunities consultancy, multi-bilateral healthcare cooperation research， she has rich experience in policy and industry coordination. She takes the lead in many ministry-sponsored projects including drug distribution system research, emerging pharmaceutical market development, China’s pharmaceutical import and export regulation system, the globalization of Chinese healthcare industry etc. She published over 60 articles and thesis on newspapers and magazines. Ms Guo is also responsible for the China-India, China-Japan, China-Korea bilateral healthcare cooperation under government framework.

Panel Discussion: Innovative and Improved Formulation R&D and Patent Strategy

Xavier Yin
SBZL Intellectual Property
Kaoxiang Sun
Vice President, Formulation Research, R&D Center, Luye Pharmacy Group
Zhong Liu
the Deputy General Manager of Lunan Pharmaceutical Group and the Director of the Institute of Biopharmaceuticals
Xiaodan Guo
Secretary General, CCCMHPIE
Guo Xiaodan received her Master degree in Pharmacy Administration from Shenyang Pharmaceutical University, she has more than 10 years working experience in the pharmaceutical industry. She is active in formulating government trade and regulatory policies, strengthen communications between China and abroad, government and companies, proposing lots of suggestion during the revision of drug administration law, solving problems such as EU No. 62 directive, Drug manufacturing consignment, CoPP, Drug HS code and so on. She organized many industry exchange dialogues and match-making programs with EU, US, Japan, Korea, India, Africa regulatory agencies and companies. Ms Guo specializes in international market access and regulatory strategy, healthcare trade and opportunities consultancy, multi-bilateral healthcare cooperation research， she has rich experience in policy and industry coordination. She takes the lead in many ministry-sponsored projects including drug distribution system research, emerging pharmaceutical market development, China’s pharmaceutical import and export regulation system, the globalization of Chinese healthcare industry etc. She published over 60 articles and thesis on newspapers and magazines. Ms Guo is also responsible for the China-India, China-Japan, China-Korea bilateral healthcare cooperation under government framework.

Improve the Related Review System to Ensure the Quality and Safety of Drugs

Huimin Sun
Director of Packaging Materials and Pharmaceutical Excipients Certification Institute, China Food and Drug Control Institute

Study on the Selection and Stability of Drug Polymorphs

Deepak Hedge
Senior Vice President, CMC at EOC Pharma

Analysis Control and Risk Assessment of Impurities in ICH M7

Jianhua Ge
VP of Institute of KPC Pharmaceuticals

Tea Break

Complex Injection Consistency Evaluation Research and Case Study

Wenjian Cai
Head of Formulation Department, Guangdong Jiabo Pharmaceutical Co. Ltd

Injection Development Ideas and High-risk Control

Frank Fan
ICAS Pharma (Shanghai) Co., Ltd.

Interpretation of ICH M10: Bioanalytical Method Validation Final endorsed Business Plan

Fuqing Dai
Vice general manager of Nanjing Huawe Medicine Technology Development co., LTD.

Tea Break

Factors and Process of Pellets Formulation

Ying Ye
Chairman of LP Pharma

The Application of Oral Sustained-Release Drug Delivery System in Neurological Dugs

Dezhi ZHU
Formulation Director, COSCI MED-TECH CO.,LTD.

Tea Break

Difficulties in Analysis of the Pre-formulation Design of Oral Sustained-release Preparations

Gilbert Wen
CEO at Overseas Pharmaceuticals Ltd

Practical Considerations for the Development of New Drug Products via 505b(2) NDA Pathway

Hongchun Qiu
Vice President, Pharmaceutical Product Development at Prinbury BioPharm Co.

Luncheon

Panel Discussion: How to Improve the Stability of Sustained-release Injection?

Ying Ye
Chairman of LP Pharma
Gilbert Wen
CEO at Overseas Pharmaceuticals Ltd
Dezhi ZHU
Formulation Director, COSCI MED-TECH CO.,LTD.
Hongchun Qiu
Vice President, Pharmaceutical Product Development at Prinbury BioPharm Co.

R&D and Recent Progress of Pharmaceutical Preparations

Shengyan Huang
Researcher, Shanghai Institute of Pharmaceutical Industry

Tea Break

BioBAY- the First Choice for Innovative Biomedical Industrialization

Yueyi Tao
Manager, BioBAY-Changshu

Treatment Dilemma and New Drug Innovation for Central Nervous System Diseases

Anchen Guo
Director, Beijing Tiantan Hospital

Strategy and Consideration of Formulation about Novel Drugs on Different Stages

Hongyan Ma
Operation VP of Shanghai Aucta

Deep Interpretation of the Current Situation and Prospect of eCTD Implementation in China

Richard Que
Publishing Team Lead (Emerging Market, CMC and Japan), Worldwide Regulatory Operations, Pfizer

Strategies of Registration with eCTD

Winnie Yang
the Head of Life Sciences Business Process Services (LS BPS) China Operations at DXC Technology

Tea Break

Panel Discussion: Common Issues in the Submission of Registration Applications with eCTD

Handsome Ji
China Publishing Hub Lead, Pfizer
Winnie Yang
the Head of Life Sciences Business Process Services (LS BPS) China Operations at DXC Technology
Richard Que
Publishing Team Lead (Emerging Market, CMC and Japan), Worldwide Regulatory Operations, Pfizer

Luncheon

Panel Discussion：Common Problems and Strategies of the Registration in Domestic Regulations

Zhengping Wu
Vice President at Hutchinson MediPharma
Jimmy Zeng
General Manager of Zhendong Group International Department
PHD Candidate, Chemistry, City College, City University of New York, USA (1993-1999) M.A., Analytic Chemistry, City University of New York, USA (1987-1992) B.S., Chemistry, South China Normal University, Guangzhou, China (1978-1982).
Na Xu
Director of Global Regulatory Affairs, WuXi AppTec

Declaration and Capacity Building under MAH

Zhengping Wu
Vice President at Hutchinson MediPharma

Research and Development Strategy of Generics ANDA in US

Jimmy Zeng
General Manager of Zhendong Group International Department
PHD Candidate, Chemistry, City College, City University of New York, USA (1993-1999) M.A., Analytic Chemistry, City University of New York, USA (1987-1992) B.S., Chemistry, South China Normal University, Guangzhou, China (1978-1982).

Tea Break

Consistency Evaluation and Technical Guidance of Sustained-release Preparations and Reference Preparations

Mindi Xu
Deputy Director, NIFDC

Thoughts on the Consistency Evaluation of Generics Scientifically

Shaohong Jin
Chief expert on chemical drug analysis in NIFDC

Tea Break

Mistakes in BE Trial of Generic Drugs

Dongsheng Ouyang
Chairman of Changsha Duzheng biotechnology Co., Ltd.

Panel Discussion: Consistency Evaluation of Quality and Efficiency of Poorly Soluble Preparation

Jianjun Guo
General Manager/Test Facility Manager of EverPro Medical Co., Ltd.
Mindi Xu
Deputy Director, NIFDC
Shaohong Jin
Chief expert on chemical drug analysis in NIFDC
Dongsheng Ouyang
Chairman of Changsha Duzheng biotechnology Co., Ltd.
Yali Liu
GCP Expert, Professor of the First Affiliated Hospital of Shantou University Medical College

Luncheon

Bioequivalence Test and Consistency Evaluation of High Variation Drugs

Yali Liu
GCP Expert, Professor of the First Affiliated Hospital of Shantou University Medical College

Bioequivalence Research and Technical Challenges in Inhalations

Yue Tang
Associate Professor, China Pharmaceutical University, visiting scholar at Cornell University

Analysis of the Main Points of Evaluation of Internal and External Consistency of Slow Control Agent

Li Zeng
CEO of Jing Medicine

Tea Break

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