アジェンダ


1日目
 

2016年3月29日 (火)

8.00
登録手続き、コーヒー
スピードネットワーキング:出席者同士の名刺交換と交流

8.50
IBC Asia代表による歓迎の挨拶

8.55
議長による開会の挨拶

中国市場の展望

9.10
最高責任者レベルの幹部によるパネルディスカッション:研究開発市場の可能性と課題

  • Current drug development scenario in China vs. the West
  • How do you bring products to market quickly and cost effectively in China?
  • Can the local Chinese pharma companies sustain R&D innovation?
  • Encouraging innovation and healthy development of the pharmaceutical industry
  • What is the future of drug development in China?

Moderator:
Li Chen, CEO, Hua Medicine, China

Panelists:
Xian Ping Lu, CEO, Shenzhen Chipscreen Biosciences, China
Friedhelm Blobel, CEO, SciClone Pharmaceuticals, USA & China
Ming-Chu Hsu, Chairman of the Board & CEO, TaiGen Biotechnology, Taiwan
Weikang Tao, CEO, R&D Centre, Shanghai Hengrui Medicine, China

9.50
パネルディスカッション:規制についての最新情報と医薬品部門の変化−最近の動き、トレンド、影響

  • Encouraging innovation and healthy development of the pharmaceutical industry
  • Recent changes and updates in the pharmaceutical and medical device sectors – What to look out for?
  • Meeting the growing clinical development demand – Increasing recruitment to address approval delays and review process
  • Enhancing your talent pool with the right experts to spearhead governmental oversight and supervision

Panelists:
Dr. XU Ming, Vice President, China Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMHPIE), China
Dr Meir-Chyun Tzou, Senior Researcher & Former Director of Division of Pharmaceutical Affairs, Taiwan Food and Drug Administration (TFDA), Taiwan
Wang Xin, Senior Director – International Affairs, China Pharmaceutical Innovation and Research Development Association (PhIRDA), China

10.30
午前の休憩

11.15
議長の冒頭発言

アジア地域における臨床試験の現状

11.20
世界各地で行われている医薬品開発プロジェクトでの臨床試験実施状況のギャップ:アジアに対する期待と現在の地位

  • Has Asia delivered in this regard?  How can we "close the gap"?
  • Asia's current position and potential in drug development 
  • Exploring regulatory, recruitment and execution challenges in Asia: Issues posed for global development programs
  • The myth of the "Asian Phenotype" challenges posed to large pharmaceutical companies and how do they overcome them?
  • Ensuring "Asian voice" is heard in global drug development programs

Dan Paulson, Vice President, Global Clinical Development, Group Head, Cardiometabolism Risk Management and Anti-infectives, Bayer HealthCare Pharmaceuticals, China

12.20
パネルディスカッション:中国での臨床試験を通じて世界規模での医薬品開発を加速させるための取り組み

  • Focusing on development in China in global development programmes
  • Regulatory frameworks in China to support drug development
  • Evolving role of China in the Asian drug discovery to development landscape
  • What does the future look like for drug development in China: Will it be a leader among Asia's drug development titans?

Panelists:
Ming-Qiang Zhang, Vice-President, Research & Development, Amgen, China
Joan Shen, Vice President, Global Development Head, J&J, China
Dan Paulson, Vice President, Global Clinical Development, Group Head, Cardiometabolism Risk Management and Antiinfectives, Bayer HealthCare Pharmaceuticals, China
Ye Hua, Senior Vice President, Clinical Development and Regulatory Affairs, Hutchison Medipharma, China

1.00
各社の幹部を交えた昼食会

VIP Table 1: Samantha Du, CEO, Chairman of the Board, Zai Laboratories, China

VIP Table 2: Weikang Tao, CEO, R&D Centre, Shanghai Hengrui Medicine, China

VIP Table 3: Yin Xiang Wang, CEO, Betta Pharmaceuticals, China

ラベリング

2.00
スマートラベリングの最新動向

  • E-label technology that enables updating expiry dates in real time without additional physical labeling effort
  • Benefits costs (avoid relabeling), security (avoids manual relabeling mistakes), speed of expiry updates
  • Special importance with clinical trials guideline annex VI (no IVRS & primary packaging expiry labels)
  • Modular system that allows customization

Frank Jaeger, Managing Director, Faubel & Co., Germany

臨床プロジェクト管理のベストプラクティス

2.40
パネルディスカッション:臨床試験の登録から第IV相試験までプロジェクトを成功裏に進める方法

  • Understanding the requirements of registration trials and Phase IV studies
  • Utilizing trial data to expand phase IV indication and add value to the drug development programme
  • Making commitment studies and fulfilling the requirements through transition processes
  • Expanding drug indications based on transitions from clinical trials to post marketing studies
  • Working with the top KOL  and getting them on board to show them the value of your product

Panelists:
Joan Shen, Vice President, Global Development Head, J&J, China
Benny Li, Vice President, Clinical Development, Takeda Pharmaceuticals, China
Cristina Chang, Country Medical Director, Celgene, Taiwan
Shell Li, Former Head of Clinical Research, Boehringer Ingelheim Pharmaceuticals, Chief Medical Officer, Vice President, Global Clinical Development, HRYZ Biotech, China

3.20
午後の休憩

4.00
パネルディスカッション:中国で腫瘍治療薬の臨床開発を加速させるための取り組み:関連組織の幹部による討論

  • Oncology drug discovery and development research initiatives in China
  • How can complex oncology trials be run in China and potentially accelerated?
  • Managing a complex oncology development programme in China
  • Collaboration between different stakeholders and incorporating latest new regulations in oncology development programmes

Panelists:
Li Yan, Vice President, Head Unit Physician, Oncology R&D, GlaxoSmithKline Pharmaceuticals, USA

5.00
パネルディスカッション:臨床試験予算の管理を効果的に進めることを目的とした協力の手法と組織の戦略

  • Identifying potential members and stakeholders of a budgeting team
  • Identifying reasonable and hidden costs involved in budgeting
  • Understanding the value of a feasibility review
  • Implementing cost-effective budgeting strategies for trials in China

Panelists:
Wang Xiao Mei, Director, Clinical Operations, TenNor Therapeutics, China
Geng Wu, Head of Clinical Project Management China, Development East Asia & Network, UCB, China
Daisuke Yamashita, Associate Director, Strategic Project Management, Takeda Development Centre Shanghai, China

5.40
議長の総括

1日目終了

2日目
 

2016年3月30日 (水)

8.00
登録手続き、コーヒー
スピードネットワーキング:出席者同士の名刺交換と交流

8.50
議長の冒頭発言

臨床開発のための最適な道筋の選択

9.00
ケーススタディ:中国における生物製剤開発の加速化

  • Overview of the Biologics drug market in China
  • Clinical Biosimilar development in China
  • Next generation Biologics drug development in China
  • Antibody-Drug Conjugates (ADC)
  • Bispecific Antibodies

Gu Jin Ming, Executive Director, Biopharmaceutical R&D, Shanghai Hengrui Medicine, China

9.40
ケーススタディ:中国の製薬会社が世界各地で行っている臨床試験の期間を短縮するうえで重要なプラットフォームとなる東南アジア

  • Malaysia as a clinical trial hub in Asia Pacific
  • Clinical trial initiation – opportunities and challenges
  • Tackling challenges encountered in trial start-up
  • Clinical trial timeline acceleration strategies
  • Existing models for trial start-up – is there room for improvement?

Jeffrey Yablon, Vice President, Business Development, General Manager – Asia, Indipharm, Malaysia

10.20
午前の休憩

11.00
ケーススタディ:台湾における臨床開発の道筋

  • What is the clinical development pathway and outlook for pharma companies in Taiwan?
  • Why is Taiwan emerging as a lucrative destination for drug development?
  • Government support and collaboration for favorable clinical development in Taiwan

Nathan Chen, Vice President, Chief Medical Officer & Head of Global Medicine Development, OBI Pharma, Taiwan

戦略的な提携関係と臨床試験のアウトソーシング

11.40
パネルディスカッション:世界規模での戦略的提携関係を地域レベルで実現するための取り組み:中国における迅速でコスト効率の高い臨床試験の将来像

  • Key differences in strategic partnerships and project-based outsourcing in China
  • What are the key considerations in ensuring effective execution on a regional level?
  • Will strategic partnerships lower costs and manage to build long-term relationships between the stakeholders involved in clinical trials?

Dejun Tang, Head, Analytics, Integrated Information Sciences China, Novartis, China
Christina Bodurow, Senior Director, External Sourcing, Development Center of Excellence, Eli Lilly and Co, USA
Yi Yang, Director, ASO (Internal Medicine), USPV, Sanofi, USA

12.20
中国で進化を続ける提携のモデルとCRO選定に際しての課題

  • Key considerations for cost-effective trials in China thought partnerships
  • How do Pharma companies ensure balance between quality and cost when outsourcing to a CRO?
  • Vendor management considerations for accelerating trials
  • Outsourcing models for global and local CROs, factoring pricing based on global headquarters for international CROs

Christina Bodurow, Senior Director, External Sourcing, Development Center of Excellence, Eli Lilly and Co, USA

1.00
各社の幹部を交えた昼食会

VIP Table 1: William Cao, CEO, Cellular Biomedicine Group, USA

VIP Table 2: Yi Yang, Director, ASO (Internal Medicine), US Pharmacovigilance, Sanofi, USA

VIP Table 3: Shell Li, Chief Medical Officer, Vice President, Global Clinical Development, HRYZ Biotech, China

臨床試験の実施の基準 (GCP) と治験実施施設の管理

2.00
治験依頼者とキーオピニオンリーダー (KOL) や治験実施施設との関係を利用し、中国で臨床試験を成功裏に進めるための取り組み

  • Key factors for success of trials from Pharma perspective – KOL and site relationships
  • Identifying the right KOL for your study: Capability of the KOLs and willingness to be involved in new development
  • How to leverage the relationship between KOL and communication between sites-sponsors to accelerate trial timelines in China?
  • Developing a sustained KOL management program across the product development cycle
  • Reviewing recent trends and creative ways to engage KOL in trials

Yi (Gloria) Wang, Chief China Medical Development and Medical Monitor Asia, United Therapeutics, China

2.40
中国での臨床試験に関するプロセスとベンダー監督体制の改善:アウトソーシングされた臨床試験の品質、コンプライアンス、投資収益の確保

  • Quality management systems principles and methods
  • Criticality for early risk identification with a CRO in order to execute adequate vendor oversight Identifying key elements of an internal communication plan for vendor oversight for business and team success
  • Identifying metrics for utilization when outsourcing any aspect of clinical trial to a vendor

3.20
午後の休憩

臨床データの品質

4.00
臨床試験における品質保証の手段とコンプライアンス:複数の治験実施施設における検査対応体制の確立

  • Critical parameters for site inspection readiness in trials – trial initiation and risk assessment
  • Inspection readiness risk assessment plan for multiple trial sites in multiple countries
  • Communication between stakeholders to ensure smoother process for inspection readiness and adherence to compliance
  • What are the expectations of trial sponsors for CROs in terms of inspection readiness?

Liping Zhou, Global Inspection Manager, Asia Pacific/Africa/Middle East, Bayer HealthCare, China

4.40
中国におけるデータ関連業務の質向上:臨床試験の電子マスターファイルと世界的な医薬品開発の質を確保するための作業

  • Centralized data operation processes: What challenges and Opportunities?
  • Transitioning into e-Trial Master Files: Challenges and opportunities
  • Trials of the Future: Improved Quality Data Operation Processes and Accelerated Development
  • Delivering optimum data quality: how to address key pharmaceutical concerns?
  • Case studies and lessons learnt
  • Using quality control to improve patient outcomes

5.20
議長の総括、Clinical Trials China閉幕

プレカンファレンス
フォーカスデイ

2016年3月28日

ワークショップA:9:00〜16:15

9.00
議長による開会の挨拶

9.10
中国におけるCROの展望−品質、コスト効率、製薬会社側の期待を両立させながら臨床開発プログラムを推進していくための取り組み

  • What makes a Chinese CRO leader and can CRO growth be sustained in completion?
  • How to ensure sponsorテュs needs are met for trials in China and outside China?
  • Key considerations in ensuring trial quality from project initiation through clinical operation phases
  • How can CROs delivery optimum trial quality and balance cost-effectiveness for pharma companies in Asia? How to balance with costs faced by CROs themselves?

Dan Zhang, Chief Executive Officer, Fountain Medical Development, China

10.30
午前の休憩

11.00
中国におけるメディカルライティング−重要性が高まる専門職

  • The expanding role of the medical writer in drug development in China
  • Building the China medical writing team
  • Best practices in medical writing to meet the needs of local and global project teams

Julia Cooper, Vice President, Head of Global Medical Writing Services, PAREXEL International, China

12.15
昼食

1.15
セントラルラボ市場で指導的な地位を確保するための条件

  • Analysis of Central Lab market growth over the years
  • A look forward: Can the local CRO industry boom continue or will it also come to an end?
  • Growth through acquisition and costs involved in developing operational capability

2.30
午後の休憩

3.00
CROの視点:医薬品の安全性に対する中国の規制

  • Practice of drug safety management in clinical trials (registration study and PMS study): AE/SAE reporting, DSUR/PSUR, PMP
  • SAE reporting (SUSAR), reconciliation  and narrative preparation

Chuck Zhu,  Pharmacovigilance  head, R&G Pharmastudies, China

4.15
プレカンファレンスフォーラム終了

ポストカンファレンス
ワークショップ

2016年3月31日

ワークショップB:9:00〜17:00

臨床試験プロジェクトの管理とベンダーの監督に関するマスタークラス

このワークショップは、アジア地域における臨床試験プロジェクトの管理とベンダー管理のベストプラクティスについて学びたいと考えているすべての専門技術者を対象としたものであり、朝から夕方まで行われるワークショップを通じて、出席者同士が経験を披露し合いながら、様々な問題についての識見を得ることができます。

  • 複雑な臨床試験の計画立案と管理
  • 臨床試験での複数の管轄権にまたがる法規上のリスクへの対応
  • プロジェクトのリスクと質の管理
  • 意思疎通と利害関係者の管理
  • 調達業務の管理
  • 臨床試験の全過程を通じてのベンダーの監視と管理

 

Workshop Leaders:
Cristiana Spontoni, Partner, Healthcare and Lifesciences, Jones Day, Belgium
Maureen Bennett, Partner, Healthcare and Lifesciences, Jones Day, USA


* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

 

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