2018 Drug Safety and Quality Management ForumDownload the Agenda

Location: Hall N6 Meeting Room

Contact Us: Anthea JU Tel: 86-021 3339 2256 anthea.ju@ubmsinoexpo.com

• Date: 20 June, 2018 Session One: Regulatory Environment and Risk Control
• 09:45-10:15 REGISTRATION
• 10:15-10:30 OPENING REMARKS Shaoxiong Chen     President, Shanghai Biopharmaceutics Industry Association (SBIA)
  
• 11:30-12:00 Drug Safety Monitoring and Risk Management in the Era of Globalization and Big Data Sandy Zhang     Director, Safety Risk Lead，Pfizer (China) R&D Center
  
• 12:00-12:10 CHAIRPERSON’S REMARKS Shaoxiong Chen     President, Shanghai Biopharmaceutics Industry Association (SBIA)
  
• 12:10-13:15 LUNCH & EXHIBITION VISIT
• Session Two: Quality Management in Biological Drugs
• 13:15-13:30 REGISTRATION
• 13:30-14:15 The Study of Quality Control of Biotech drugs in China
• 14:00-14:45 Challenges in the Production of High Quality Pharmaceuticals - Key Quality Management and Testing Considerations for Excellence NIGEL J. SMART     President and Founder, SMART Pharmaceutical Consulting NIGEL J. SMART
  
• 14:45-15:15 Discussion on Quality Assurance of Clinical Drugs Under MAH System MAH Yilei Fu     VP, Quality Assurance, Hua Medicine
  
• 15:15-15:45 Recent Advances on Genotoxic impurities control in Pharmaceuticals Dong-ying Chen     Professor, Shanghai Institute of Materia Medica, CAS
  
• 15:45-16:00 Close of Day

2018 Innolab SalonDownload the Agenda

Location: Hall N1 Meeting Area B80

• Date: 20 June,2018
  Session One:
  
• 10:15-10:30 Registration
• 11:00-12:00 Agela Process Manufacturing Capabilities Matthew Jiang     BD Manager，Bonna-Agela（A Phenomenex Company）
  
• 15:00-15:15 Coffee Break
• 16:15-16:30 Chairperson's Remarks
• Date: 21 June,2018
  Session Two:
  
• 10:15-10:30 Registration
• 15:15-16:15 The era of total biology laboratory automation is coming Yuyou Hao     CEO,Shanghai MediaCenter Biotechnology Co.,Ltd.
  
• 16:15-16:30 Chairperson's Remarks
• Date: 22 June, 2018
  Session Three:
  
• 09:30-09:45 Registration
• 12:15-12:30 Chairperson's Remarks

2018 Hot topic discussion on Pharm Lab and Supply ChainDownload the Agenda

Location: Hall N6 Meeting Room A

Description: The Pharm lab and Supply Chain hot topic forum aims to provide first-hand experience and knowhow about recent regulatory trend and laboratory practice. The forum will be helpful for those companies who wish to register or has already exported their products to oversea markets. Experts from China, US and Europe will discuss with you hot topics from angle of QC technique and regulatory requirements.

• Date: 21 June, 2018
  Session One: Regulatory Trend of Quality Control
  
• 09:20-10:00 Registration
• 10:00-10:20 Opening address, Pharm and Health Products industry insights CHINA CHAMBER OF COMMERCE OF MEDICINES & HEALTH PRODUCTS IMPORTERS & EXPORTERS （CCCMHPIE）     
  
• 10:20-10:50 Trend of China Pharmacopeia CFDA or Affiliated Institute for Food and Drug Control     
  
• 10:50-11:20 Regulation requirements on Impurity and Genotoxicity impurity European third party laboratory     
  
• 11:20-11:50 Good supplier certification program CCCMHPIE Quality Control and Application Technology Committee     
  
• 11:50-13:20 LUNCH & EXHIBITION VISIT
• Session Two: Case study for Overseas products registration
• 13:20-13:50 A Perspective on the Market Growth and Bioanalytical Strategy for Regulatory Requirement US third party laboratory     
  
• 13:50-14:20 Case study: GMP compliance related with oversea products registration Intertek Life Bridge     
  
• 14:20-14:50 Regulatory challenges and experience sharing of export products compliance Pharma Enterprises representative     
  
• Session Three: Trends of supply chain audit and buyers’compliance requirement
• 14:55-15:25 Introduction of CODEMA PHARMA Rating Program CODEMA     
  
• 15:25-15:55 Buyer initiated supply chain audit trend Multinational Third party auditing group     
  
• 15:55-16:25 Key points during US FDA inspection Former US FDA official     
  
• 16:25-16:30 Wrap up

Microbe and Medium Risk Detection and Quality Control ForumDownload the Agenda

Location: Hall N6 Meeting Room A

Description: The forum is designed to gather famous Chinese microbial experts to jointly discuss and share on the risks of membrane filtration method in microbial detection and roles and advantages thereof in microbial control, and provide one-on-one exchanges with experts to discuss and solve problems in the work in a pertinent manner.

• Date: 22 June, 2018
• 8:30-9:00 Registration
• 9:00-9:10 Opening
• 9:10-10:30 Risks of Membrane Filtration Method in Microbial Detection and Control Thereof
• 10:30-10:40 Q&A
• 10:40-11:50 Commercial Aseptic Plating Medium Quality Control
• 11:50-12:00 Q&A

2018 Drug Safety and Quality Management ForumDownload the Agenda

Location: Hall N6 Meeting Room

Contact Us: Anthea JU Tel: 86-021 3339 2256 anthea.ju@ubmsinoexpo.com

• Date: 20 June, 2018 Session One: Regulatory Environment and Risk Control
• 09:45-10:15 REGISTRATION
• 10:15-10:30 OPENING REMARKS Shaoxiong Chen     President, Shanghai Biopharmaceutics Industry Association (SBIA)
  
• 11:30-12:00 Drug Safety Monitoring and Risk Management in the Era of Globalization and Big Data Sandy Zhang     Director, Safety Risk Lead，Pfizer (China) R&D Center
  
• 12:00-12:10 CHAIRPERSON’S REMARKS Shaoxiong Chen     President, Shanghai Biopharmaceutics Industry Association (SBIA)
  
• 12:10-13:15 LUNCH & EXHIBITION VISIT
• Session Two: Quality Management in Biological Drugs
• 13:15-13:30 REGISTRATION
• 13:30-14:15 The Study of Quality Control of Biotech drugs in China
• 14:00-14:45 Challenges in the Production of High Quality Pharmaceuticals - Key Quality Management and Testing Considerations for Excellence NIGEL J. SMART     President and Founder, SMART Pharmaceutical Consulting NIGEL J. SMART
  
• 14:45-15:15 Discussion on Quality Assurance of Clinical Drugs Under MAH System MAH Yilei Fu     VP, Quality Assurance, Hua Medicine
  
• 15:15-15:45 Recent Advances on Genotoxic impurities control in Pharmaceuticals Dong-ying Chen     Professor, Shanghai Institute of Materia Medica, CAS
  
• 15:45-16:00 Close of Day

2018 Innolab SalonDownload the Agenda

Location: Hall N1 Meeting Area B80

• Date: 20 June,2018
  Session One:
  
• 10:15-10:30 Registration
• 11:00-12:00 Agela Process Manufacturing Capabilities Matthew Jiang     BD Manager，Bonna-Agela（A Phenomenex Company）
  
• 15:00-15:15 Coffee Break
• 16:15-16:30 Chairperson's Remarks

2018 Innolab SalonDownload the Agenda

Location: Hall N1 Meeting Area B80

• Date: 21 June,2018
  Session Two:
  
• 10:15-10:30 Registration
• 15:15-16:15 The era of total biology laboratory automation is coming Yuyou Hao     CEO,Shanghai MediaCenter Biotechnology Co.,Ltd.
  
• 16:15-16:30 Chairperson's Remarks

2018 Hot topic discussion on Pharm Lab and Supply ChainDownload the Agenda

Location: Hall N6 Meeting Room A

Description: The Pharm lab and Supply Chain hot topic forum aims to provide first-hand experience and knowhow about recent regulatory trend and laboratory practice. The forum will be helpful for those companies who wish to register or has already exported their products to oversea markets. Experts from China, US and Europe will discuss with you hot topics from angle of QC technique and regulatory requirements.

• Date: 21 June, 2018
  Session One: Regulatory Trend of Quality Control
  
• 09:20-10:00 Registration
• 10:00-10:20 Opening address, Pharm and Health Products industry insights CHINA CHAMBER OF COMMERCE OF MEDICINES & HEALTH PRODUCTS IMPORTERS & EXPORTERS （CCCMHPIE）     
  
• 10:20-10:50 Trend of China Pharmacopeia CFDA or Affiliated Institute for Food and Drug Control     
  
• 10:50-11:20 Regulation requirements on Impurity and Genotoxicity impurity European third party laboratory     
  
• 11:20-11:50 Good supplier certification program CCCMHPIE Quality Control and Application Technology Committee     
  
• 11:50-13:20 LUNCH & EXHIBITION VISIT
• Session Two: Case study for Overseas products registration
• 13:20-13:50 A Perspective on the Market Growth and Bioanalytical Strategy for Regulatory Requirement US third party laboratory     
  
• 13:50-14:20 Case study: GMP compliance related with oversea products registration Intertek Life Bridge     
  
• 14:20-14:50 Regulatory challenges and experience sharing of export products compliance Pharma Enterprises representative     
  
• Session Three: Trends of supply chain audit and buyers’compliance requirement
• 14:55-15:25 Introduction of CODEMA PHARMA Rating Program CODEMA     
  
• 15:25-15:55 Buyer initiated supply chain audit trend Multinational Third party auditing group     
  
• 15:55-16:25 Key points during US FDA inspection Former US FDA official     
  
• 16:25-16:30 Wrap up

2018 Innolab SalonDownload the Agenda

Location: Hall N1 Meeting Area B80

• Date: 22 June, 2018
  Session Three:
  
• 09:30-09:45 Registration
• 12:15-12:30 Chairperson's Remarks

Microbe and Medium Risk Detection and Quality Control ForumDownload the Agenda

Location: Hall N6 Meeting Room A

Description: The forum is designed to gather famous Chinese microbial experts to jointly discuss and share on the risks of membrane filtration method in microbial detection and roles and advantages thereof in microbial control, and provide one-on-one exchanges with experts to discuss and solve problems in the work in a pertinent manner.

• Date: 22 June, 2018
• 8:30-9:00 Registration
• 9:00-9:10 Opening
• 9:10-10:30 Risks of Membrane Filtration Method in Microbial Detection and Control Thereof
• 10:30-10:40 Q&A
• 10:40-11:50 Commercial Aseptic Plating Medium Quality Control
• 11:50-12:00 Q&A