Language: 简体中文 English
Agenda

WORKSHOP
Dissolution, Bioequivalence, Product Performance and Quality
May 30-June1, 2019(May 30 Registration)

Location: Orient Haitian Hotel Yantai,Shandong,China
Workshop Chairs: Dr. Xujin Lu
  Dr. Baoming Ning
  Dr. Susan D’Souza
Organizing Committee: AAPS In-Vitro Release & Dissolution Testing Community
  Chinese National Institute for Food and Drug Control
  Shandong Institute for Food and Drug Control
  Yantai Administration for Market Regulation
  Yantai Institute for Food and Drug Control
  Chinese Journal of New Drugs
  Chinese Journal of Pharmaceutical Analysis
Objectives:  
The goal of this workshop is to discuss the following aspects and enable the attendees:
1.Use of dissolution as a tool for drug development, biowaiver, and bioequivalence studies.
2.Share Chinese research activities and collaborations in dissolution, apparatus calibration, bioequivalence, and drug specification setting topics.
3.Learn international current trend, hot topics, and new methodologies and technologies in dissolution and drug release studies and applications.
4.Disseminate Chinese regulatory information for dissolution testing and bioequivalence. Understand the drug inspection policies that are related to dissolution in drug product development, cGMP, SUPAC, and generic product quality.
LECTURE SCHEDULE
Day 1:May 31st,2019
8:15 - 8:30 Opening remarks
Session Theme: Dissolution - International Trends and New Regulation (Moderator: Dr. Xujin Lu)
Learning Objectives:
1.Introduction to new dissolution guidelines from international health authorities
2.Presentation of Chinese drug evaluation agency policy and practice on drug product quality
3.Dissemination of regulatory information for dissolution testing and biowaiver
8:30 - 9:15 FDA guideline and regulatory perspective to the quality, quality evaluation of solid oral dosage drug products, dissolution testing and biowaiver.
Speaker: Dr. Sandra Suarez (FDA, AAPS member)
9:15 - 10:00 Chinese Drug Evaluation (CDE) agency requirement and perspective to the quality and quality evaluation of solid oral dosage drug products.
Speaker: TBD (CDE, China)
10:00 - 10:30 Break
10:30 - 11:15 Application of USP apparatus 4
Speaker: Dr. Diane J. Burgess (University of Connecticut, AAPS Member)
11:15 - 12:00 Applications of USP apparatus 3, case studies
Speaker: Dr. Baoming Ning (NIFDC)
12:00 - 12:15 Question & answer session – Panel discussion
Moderator: Dr. Xujin Lu
12:15 - 1:15 Lunch
Session Theme: Dissolution Technologies and Implementation (Moderator: Dr. Baoming Ning)
1.Introduction to USP dissolution devices and methodologies
2.Digest the case studies relative to the applications of USP dissolution apparatus
3.Presentation of new technology that enhance the understanding of drug release mechanisms
1:15 - 1:30 Introduction to American Association of Pharmaceutical Scientists (AAPS), the In Vitro Drug Release and Dissolution Testing (IVRDT) Community, and related activities.
Speaker: Dr. Susan D’Souza (PTC, USA, AAPS Member)
1:30 - 2:15 Application of USP apparatus 4, case studies
Speaker: Dr. Nikoletta Fotaki (U of Bath, UK, AAPS member)
2:15 - 3:00 Application of 3D Image Technology in Drug Development
Speaker: Dr. Liu Zhen (MSD, USA)
3:00 - 3:30 Break
3:30 - 4:15 Key Framework Technologies in the Characterization and Optimization of Microstructures in Drug Release System
Speaker: Shawn Zhang (DigiM, USA)
4:15 - 5:00 Application of Spectroscopic Imaging Technologies to Dissolution and Formulation Development.
Speaker: Dr. Xujin Lu (BMS, USA, AAPS Member)
5:00 - 5:15 Question & answer session – Panel discussion
Moderator: Dr. Baoming Ning
5:30 - 7:00 Dinner
7:00 - 9:00 Technology exchange
   
Day 2:June 1st,2019
Session Theme: Biorelevant, In Vivo Predictive, and Clinical Relevant Dissolution (Moderator: TBD)
Learning Objectives:
1.Review IVIVC requirements, methodologies and applications
2.Introduction of PBPK based modeling and simulation in support of drug product development
3.Critical aspects of clinical relevant dissolution specification
4.Points of biorelevant dissolution method development for drug product quality control
8:15 - 9:00 In vivo predictive dissolution and IVIVC
Speaker: Dr. Johannes Kramer (PHAST, Germany, AAPS Member)
9:00 - 9:45 PBPK based modeling and simulation in support of drug product development
Speaker: Dr. Nikoletta Fotaki (University of Bath, AAPS Member)
9:45 - 10:15 Break
10:15 - 11:00 Establishing Clinically Relevant Dissolution Specifications --- Possible
Speaker: Dr. Sandra Suarez (FDA, AAPS member)
11:00 - 11:45 Dissolution Technology and Formulation Design(TBD)
Speaker: TBD(TBD)
11:45 - 12:00 Question & answer session - Panel discussion
Moderator: TBD
12:00 - 1:00 Lunch
Session Theme: Emerging topics in dissolution and challenges (Moderator: TBD)
Learning Objectives:
1.Recognition of the challenges from new drug delivery and new manufacturing process
2.Dissemination of the considerations and perspectives from regulatory agencies
3.Presentation of new concepts and methodologies to prepare for the new challenges
1:00 - 1:45 Application of dissolution technology in API quality characterization.
Speaker: Samir Haddouchi (SPS, France)
1:45 - 2:30 RTRA needed predictive and clinically relevant dissolution models for continuous manufacturing
Speaker: Dr. Xujin Lu (BMS, USA, AAPS Member)
2:30 - 3:00 Break
3:00 - 3:45 Dissemination of USP Stimuli on “In Vitro Release Test Methods for Drug Formulations for Parenteral Applications”.
Speaker: Dr. Johannes Kramer (PHAST, Germany, AAPS Member)
3:45 - 4:30 Drug release from long acting biodegradable microspheres of injectables
Speaker: Dr. Susan D’Souza (PTC, USA, AAPS Member)
4:30 - 5:00 Application of In Vitro Dissolution Technology in Development for Modified Release Dosage Forms
Speaker: Dr. Li Youxin (Shandong Luye Pharma Group)
5:00 - 5:15 Question & answer session – Panel discussion
Moderator: TBD
5:15 - 5:30 Closing remarks
  Dr. Xujin Lu and Dr. Baoming Ning
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2016年6月21-22日

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2016年5月31日

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2016年6月20日