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Quality in clinical research, drug safety & pharmacovigilance
Chairpersons会议主持
Hannah Chen
Guo Xiaojun, 郭晓军
1. What are the key inspection findings?
Challenges we are facing in conduct clinical trials (20 min)
Byungja Marciante (FDA)
FDA Officer (Hannah to further confirm)
2. Panel discussion
¨ Insufficient source documents – main challenge due to medical system in China?
¨ Missing data (AE and SAE)
¨ Safety information reconciliation between clinical database and safety database due to inconsistency of source document reporting
Helen Li (Pfizer)
Chen Yuling (307 Hospital)
Zhou Aiping
(CAMS, Tumor Hospital)
Wang Yuhong (Roche)
A Sr. CRA (TBD)
3．Case study: How do we improve source documents to meet GCP requirements? 1 case oncology and 1 case non-oncology protocols and 1 case of SAE case to be distributed to audiences in advance; some of them will be invited to the panel to join the discussion
¨ Verification of subject eligibility according protocol requirements – what source document we must have
¨ Clear Definition of SAE (Death as outcome, disease progression)
¨ Clear instruction of SAE management
Above panelists + some audiences
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Session 1：
AD (Adaptive Design)
Chairpersons会议主持
Roger QU（Pifzer）曲鹏
Robert LUO (Pifzer)罗震
Panel or Debate
Topics:
Part 1 – an oncology case (or other applicable disease) . Imbed the “guidance comparison” session in this:
– Is China ready for adaptive design (e.g., DMC ready)?
– Discuss different options: fixed sample, GSD, SSR
– Why we need adaptive design and How can the adaptive design increase quality (speed, resource, result)
– How the ICH，FDA guidance, and SFDA guidance differs (focusing on why, what, how)
Format:
– A panel discussion for DMC in China
(The panel could consist of the speakers in the first part plus all of the lead and maybe more )
其他讲者:
1 speaker from the regulatory perspective on the practice of DMC and adaptive design in its broad sense (Sue-Jane Wang)
– 1 speaker from the perspective of DMC members (Irving K. Hwang)
– 1 speaker from China, topic could be the current practice of DMC in China or comparison of sFDA guidance and ICH and FDA guidance (we are seeking a speaker familiar with the current practice in China, not necessarily a statistician)
Part 2 – 1 or 2 cases for adaptive designs
(The format of the second part could be further refined.)
Roger QU
曲鹏（Pifzer）
Robert LUO
罗震 (Pifzer)
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Chairpersons会议主持
James CAI
Zheng GU(顾峥)
Irving Wang (王敏)
Session 1:
What is MA/SA, its role & responsibility in biopharmaceutical value chains and transferring scientific data into patient centric medical practices
(Half of a day)
Topics:
• Overview of Medical & Scientific Affairs definition, position, role, responsibility, competency requirement in professional medical information communication, patient safety, regulatory compliance and product life cycle management
Speaker:
Dr. Rick Sax, VP Global R&D of AstraZeneca (TBC)
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Reshape your clinical development strategy in China? Join the experts to learn if China clinical development has delivered its promises, find out what are the gaps, and how to reshape your strategy in the next 3-5 years.
Chairpersons会议主持
Frank JIANG
Lingshi TAN
Tony ZHANG
Session 1:
Phase Capability, Crossing the chasm
-The data burden and regulatory hurdle for first in man trial in China are relatively high compared with other countries. Experts and industry observers will delineate root causes for this phenomenon and contemplate solutions to bridge the gap in the drug development value chain. Capabilities (readiness) will be a focus of the discussion.
Potential speakers:
-HU Bei 胡蓓
-ZHANG Dan (Fountain Med)张丹
-GAN Rongxing (Covance)甘荣新
-Roisin Armstrong/Chew Lan Chong
Session 2:
Has China delivered its promises for global pivotal studies? Strategy, Gap analysis and Recommendation
Topic:
• Growing market potential and abundance in patients needing medical breakthroughs in China have driven the number of international muliticentered trials in China to triple in 2009 over 2008. Numbers aside, what has kept the country from becoming a dominant player for first in kind pivotal trails? Where are the limiting factors and how are the problems addressed?
Potential speakers:
-Rae Yuan
-Wang Min
-Karen Atkin (AstraZeneca)
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Chairpersons会议主持
John HU (USP)
Min GUI
Charles TONG
Session 1：
2010版中国药典-how to deal with different compendia
How to Strengthen the Interactions between Standard-Setting Organizations and manufacturers (如何强化标准建立机构和企业间的互动)
SFDA Perspective (new)
FDA Perspective (new)
WANG Ping or LI Huiyi
(ChP 1 speaker)
Susanne Keitel (EDQM)
John HU胡江滨(USP)
Erin Wang (Lily)
Panel Presentation + Case studies, Q&A
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| IRB/IEC practices and issues in China
Chairpersons会议主持
Paul Dai 戴欣
Mao Yimin 茅益民
Panel discussion- #1
What are the impacts of new issued IRB/IEC guideline?
Liu Haitao刘海涛
(Institute of Clinical Research, Beijing University)
Xiong Ningning
(Jiangsu Provincial Hospital of Traditional Chinese Medicine)
Eva Yang (Bayer)
Panel discussion- #2
Efficient and high quality site management
Study site management
¨ Investigator’s responsibilities
¨ Site resource management
¨ Management of clinical research center
¨ Clinical research coordinator
Li Haiyan (No. 3 Hospital of Beijing University)
李海燕（北医三院）
Hannah Chen (GSK)
Grace Wu (Pfizer)
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Topic
中国新药研发?监管的新?趋势 （1.5 h）
LI Jinju, 李金菊（SFDA）
PFDA代表,
CAO Cai/LI Jianming
曹彩／李见明（CDC）
(每位讲者25分钟，Q&A最短15分钟）
Topic 4
中国新药研发指导原则体系的完善（1.5 h）
Guidelines for New Drug research & development are one of the important tools to guide China new drug development. In the last few years, SFDA already issued more than 70? technical guidelines and more than –guidelines are requesting comments or under drafting. In this section, SFDA will provide an overview on the systemically technical guideline development planning and will illustrate, describe and discuss these new guidelines from SFDA’s point of view
HOU Renping
候仁萍（SFDA注册司)
WEN Baoshu
温宝书 (CDE)
Industry代表
(每位讲者25分钟，Q&A最短15分钟）
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Session 2：
Adopting International Standards and Improving Data Quality
Chairpersons会议主持
Joanne LIU (Merck)刘宗范
Daniel Liu (Medidata)刘川
Rachel Yang (Oracle)杨佩蓉
Panel Discussion, Q&A
Topics:
Regulatory Guidelines and international data standards with regards to computerized systems
• A newly published GCP guideline: computerized systems in clinical research – current data quality and data integrity concepts
• CDISC application and trends: e-Protocol frameworks and EDC scope with CDISC elements
• Foundation and strategy of e-clinical practice: computerized systems validation for the e-system’s lifecycle
刘川邀请到3-4位讲者
杨佩蓉正在联系CDISC的讲者，刘宗范正在寻找有关DM role和data quality的讲者
Session 2 续 (Panel Discussion)
Adopting International Standards and Improving Data Quality
Topics:
Implementing data quality measures that integrate people, process and technology
• A winning strategy on data quality — putting the right pieces together (culture, infrastructure, information technology and SOPs).
• EDC implementation in China: historical defects, current environments and challenges of data management
• Data Manager’s Role in data quality and KPI for data management process
• Improving data quality with partnerships and collaborations (Sponsor, CROs, Investigators, Clinical Data Manager, CRAs, and Biostatisticians.)
Joanne LIU (Merck)刘宗范
Daniel Liu (Medidata)刘川
Rachel Yang (Oracle)杨佩蓉 |
Session 2:
Establish practical and effective medical/scientific affairs strategy
Topics:
• Evidence based medicine in established markets and emerging markets: case study of LCM
Speaker:
Dr. Dominique Roome, VP Global Medical operations
• China experience
Speaker:
Dr. Gao Runlin, People Hospital Beijing China
• Working with Marketing and Clinicians on evidence based medical-marketing communication
• Epidemiology study and outcome study
• Post marketing study and data assembling
Speaker:
Li Huafei, Medical Liaison Manager
AstraZeneca China
• Publication and DA
• From concept, strategy, resource planning, execution and communication
Speaker:
Joyce Li, VP Medical of NovaMed Pharma
• Promotional material development and review
Speaker:
Dr. Gu Zheng, Medical Director of Sanofi-Aventis China
• Establish an a-player team
Speaker:
Dr. Jane Lin, Medical Director of Baxter China
Session 3:
Regulation update and trend Topics:
• SOX
• Legal and compliance perspective
• MOH Clinical path initiative
Speaker:
Katherine Wang, Sidley Austin LLP
Session 4:
Clinical outcome-research
Topics:
• Outcomes Research Impact in Medical Practice
Speaker:
Dr. Danyi Zhang, CMO of
Vital Strategic Research Institute (VSRI)
Session 5:
Operational excellence-Debate and Group discussion of specific cases
(2 hours)
Topics:
• All, facilitated by Dr. GU Zheng
(Roundtable discussion)
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Session 3:
Modernize clinical development through New technology
Due to its highly regulated nature and long development timeline, medicines are not normally associated with the image of cutting edge technologies. Have we overlooked what technology can deliver for improving patient adherence, data integrity, quality of the studies, and overall probability of success? This panel will invites experts from several different fields and examine the possibilities of leveraging technological innovation to speed up medicine development. A must attend session. –
Potential Speakers:
-Michael AIbara, others?
Session 4:
TCM development – What we can learn from?
– Traditional Chinese medicine (TCM) personifies personalized care, tailored therapy, systems biology, and out-come based medicine. While the complexity of multi-components and multi targets mechanism have thwarted traditional Western clinical research approach, it will be rewarding to learn with an open mind on what’s the state of art on TCM clinical development.
Potential speakers:
-Bradley Marchant
-SFDA
-(Jockey club TCM institute, HK?)
-Selwyn Fung
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Session 2:
QbD-结合案例分析以及PAT新技术介绍
Chairpersons会议主持
GUI Min (BMS)桂敏
Charles TONG (BMS)童成
Topics:
Implementation of QbD Principles in Drug Development and Real Time Release Testing (RTRT)
Drug Product Development Utilizing QbD
Speaker:
GUI Min (BMS)桂敏
Practical Considerations for Implementation of Real Time Release Testing (RTRT)
Speakers:
Charles TONG (BMS)童成
Session 3:
Supply Chains Management (SCM)
Chairpersons会议主持
John HU (USP)
Topics:
1. Pharmaceutical Reference Standards: Overview and Role in Global Harmonization (Dr. Matthew Borer, Eli Lily)
2. Vendor qualification (Dr.Joan Ruan, BMS)
3. Building a Quality Mindset with Your Partner to Manufacture Safe Clinical Materials(Dr. HUNG CHIH CHANG. Eli Lily)
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| From compliance to beyond compliance – how to manage the safety data throughout product life cycle
Chairperson会议主持
Conny Mo磨晓垚
Catherine Xie 谢珺
Presentation
Quiz and awards + Panel discussion
¨ Overview in evolving regulatory requirements from global major HAs
¨ China safety regulation and implementation challenge
¨ Safety signal detection in professional assessment of ICSR
¨ Experience sharing of Signal management and Interpretation strategies in different phases of product life cycle
Presenters:
- 1. EMEA Officer of Drug Safety
- 2. Xu Jiaqi, SFDA (Conny to confirm)
- 3. Sonja Brajovic, FDA, Medical Officer (Confirmed)
- 4. Craig Harford, VP, Safety Surveillance & RM (Pfizer)
Panelists:
Above speakers + some audiences
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Topic 5
中药研发的规范化与国际化 (1.5 h)
CHEN Yixin/WANG Hainan
陈易新/王海南（SFDA）
HU Jun胡军（CDE）
SUN He孙鹤（天士力）
(每位讲者25分钟，Q&A最短15分钟）
Topic 6
美国 aNDA 的要求与实践（2小时）
FDA代表
恒瑞代表
海正代表
With the rapidly growing pharmaceutical market in China, more and more domestic pharmaceutical companies are seeking the opportunities to enter into global market. aNDA is one of fast and cost-effective way to launch products into global market. In this section, US FDA will give an introduction on how to apply for aNDA in US. This section will also include the speakers from domestic companies to expose real cases and share their experiences about their aNDA application in US.
The analysis of the 2010 China Drug Registration Whitepaper (or the Annual Report)
In 2009, China SFDA issued its first drug registration whitepaper (annual report) in SFDA website and got very positive feedback from public. In this section, SFDA or sb else will present comprehensive information about drug registration status in 2010, analyze the drug development trends, and further goals etc.
(每位讲者25分钟，Q&A最短20分钟）
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Session 3:
Talent need in China (e.g. epidemiology, health economics, clinical sciences)
Chairperson会议主持
Tony ZHANG张彦涛 (Eli-lily)
看张彦涛的follow up，也可考虑将此session换成刘川说的内容（CDISC的内容）
Session 4:
How to design and implement a meaningful and interpretable post-marketing studies
Tony ZHANG张彦涛 (Eli-lily)
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Session 2:
Maximize Medical and Scientific Affairs contribution to drive evidence based medical communication to clinicians and medical marketing in China and/or emerging markets
Speakers:
Topics:
• What are publication strategy and how to assemble the data
• What are China regulations regarding issues PMS, Off-label communication, sharing scientific research paper, plus the practice best
• International and Asian experience and practices of MA/SA
• Ask expert @ a case Chinese MA/SA or
• Roundtable and panel discussion, case study of
• Promotional material development and review
• What are clinical path (MOH initiative)
• SOX/global compliance vs creative Medical marketing
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Chairpersons会议主持
Spring WANG
Joanne LIU
Session 1:
Focus on Quality Control in both early and late clinical Development
Speakers:
Topics:
o What are the key QC steps to drive good quality study
o What are the major findings of QC from agency perspectives
o Experiences sharing
QA/QC management at study site (LI Haiyan)
o Case studies
4 presentations inc. Case studies
Interactive panel discussion
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Session 4 – Biologics
Chairpersons会议主持
GUI Min桂敏
Topics:
- ICH Q5E biological process change
- Biotech Comparability
- Biosimilar
Proposed speakers:
CHANG Weihong (SFDA)
industry speaker (桂敏邀请)
David LIN (BCG Consulting)
Duu-Gong WU (PharmaNet Consulting)
Round Table
圆桌讨论
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1. Experiences and lessons sharing from oncology drug development
Chairperson: 会议主持
George Chen, one oncologist
Case Study
¨ Accelerating oncology portfolio in Asia
¨ Investigator perspectives: opportunities and challenges of running oncology trials in China
TBD (George to provide the list after Chinese New Year)
2. Operational excellence
Chairperson: 会议主持
Jessica Liu
Cai Yan
¨ Operational Excellence to improve trial conduction efficiency
The fundamental elements of clinical safety operational excellence – a good safety system (including database and workflow management, etc.).
Effective liaison management of sponsor, CRO and investigator/site
1. Presentation
Cai Yan
2. Presentation
Sun Yonghui (Novo Nordisk)
3. Debate
Debate host: Xu Ning (Covance)
Debate team 1-leader: Jessica Liu
Debate team 2-leader: Cai Yan
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Topic 7
2010年药品注册白皮书解读 (1.5 h)
ZHANG Wei
张伟（SFDA）
FENG Yi
冯毅（CDE）
Industry代表
(每位讲者25分钟，Q&A最短15分钟）
Topic 8
新药临床研究过程中的变更管理
(包括临床方案变更和药学毒理变更) (1.5 h)
FDA代表
PI代表
Industry代表
(每位讲者25分钟，Q&A最短15分钟）
Two backup topics —
Topic 9 • eCTD电子申报的进展
Topic 10 • Pharmaceutical IPR and data protection in China |
Session 5:
Ethnicity and Global Drug Development Panel Session
Chairperson: 会议主持
William WANG (Merck)王武保
Bob Powell (Roche)
Other Speakers:
Bruce Binkowitz (Merck)
James Hung (FDA)
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Session 2 续 |
Session 2:
Focus on QA in both early and late clinical development, plan is to especially focus on PK and phase I study QA/QC
Speakers:
Topics:
• Representatives from sponsor, investigator sites, CRO and agency to share:
o QA findings
o Case studies
o QA/QC in PK and phase I study
4 or 5 presentations inc.
Case studies
Interactive panel discussion
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Session 5 (with FDAAA)
U.S. FDA New CMC/GMP Guidance and Hot Topics
ICH Q3
Round Table Discussion
圆桌讨论
Chairperson: 会议主持
Charles TONG (BMS)童成
Topics (tentative):
¨ IND Guidance
Chuck Hoiberg
¨ Impurities and Polymorph in ANDA
Chi-wan CHEN
¨ Process Validation Guidance Mark Tucker (Genetech)
¨ PAI program.
* Chuck Hoiberg,
Chi-wan Chen,
Mark Tucker (Genetech)
(All proposed speakers are former managers in ONDC/ONDQA or former FDA field investigator)
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