アジェンダ


1日目
 

2016年3月29日

8.00am
登録手続き、コーヒー

9.00am                
歓迎の挨拶、スピードネットワーキング

9.05am              
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?

Panelists:

  • Li Chen, CEO, Hua Medicine, China
  • Xian Ping Lu, CEO, Shenzhen Chipscreen Biosciences, China
  • Friedhelm Blobel, CEO, SciClone Pharmaceuticals, USA & China
  • Ming-Chu Hsu, Chairman & CEO, TaiGen Biotechnology, Taiwan
  • Weikang Tao, CEO, R&D Centre, Shanghai Hengrui Medicine, China

09:50
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 and 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)
Dr Meir-Chyun Tzou, Senior Researcher & Former Director of Division of Pharmaceutical Affairs, Taiwan Food and Drug Administration (TFDA)
Wang Xin, Senior Director – International Affairs, China Pharmaceutical Innovation and Research Development Association (PhIRDA)

10.30    
午前の休憩

11.15
議長の冒頭発言
               

医薬品承認手続きの期間短縮を目的とした規制改革

11:20 
台湾における医薬品規制の改革と変化

  • Market outlook of Pharmaceutical Industry in Taiwan
  • New updates and changes in regulations
  • Latest regulatory framework in place and navigating through drug development

Dr Meir-Chyun Tzou, Senior Researcher & Former Director of Division of Pharmaceutical Affairs, Taiwan Food and Drug Administration (TFDA)

電子ラベリングとパッケージング

11:50
パッケージ材料と賦形剤の同時審査と評価

  • Reviewing the specizfications of excipients for better control of drugs safety
  • Developing a robust framework and guideline for package materials and excipients
  • Discussing the initial plans and review of the initiative and long term benefits from a streamlined assessment process

Ms Yan WANG, Head of Shanghai Food and Drug Packaging Material Control Center, Shanghai Municipal Food and Drug Administration (SFDA)

12:20
アジア地域における革新的なラベリングのための拠点の実現

  • Discussing the Global Labeling System
  • Integration with a global model point of view
  • Labeling in Asia and the ASEAN Harmonization

Rie Matsui, Director, Regional Labeling Head for Asia, Pfizer Japan

12:50
昼食会

市販後医薬品安全性監視

14:00
医薬品の品質管理と市販後の対応に関する規制の概要

  • Outlining quality control and essential analyses frameworks
  • Advancing quality control to accelerate production whilst adhering to post-market regulations
  • Marketing safe and therapeutically effective drugs for consistency in performance and quality whose performance is consistent and predictable

Ms Yan WANG, Head of Shanghai Food and Drug Packaging Material Control Center, Shanghai Food and Drug Administration (SFDA)

14:30
市販後医薬品特別監視に関する日本、韓国、中国の規制の違い

  • The background for China Special Drug Monitoring
  • Introduction for the regulations in Korea, China and Japan.
  • Practice challenge for Special Drug Monitoring in China

Miranda Wang, Head for Country Pharmacovigilance – R&D China, Bristol-Myers Squibb

15:00
午後の休憩

15:30
倫理観の違いに対応するための危機管理計画の立案

  • Overview on planning your Risk Management Strategy
  • Identifying the ethnic segments and how to manage these differences

Ivy WANG, Associate Director - Safety Surveillance and Risk Management, Pfizer (China) Research & Development Co Ltd Center

品質保証と偽造医薬品対策

16:00
品質文化の構築―品質管理システムを超えた取り組み

  • Experience and evidence from international GMP inspections
  • What is a Quality culture and why is it necessary
  • Key challenges when transforming to a quality culture – practical experience.

Magnus Jahnsson, Director Regulatory Affairs, Pharmadule Morimatsu AB

医療機器に関する規制

16:30
先進国の市場における医療機器規制の概要:EU、米国、日本、カナダ、オーストラリア、ニュージーランド

  • Scoping into the Australian Medicines and Medical Devices Regulation
  • Proposal for a New Zealand Regulatory Scheme for Medical Devices
  • Recent developments in the area of therapeutic goods regulations

Val Theisz, Director Regulatory Affairs, Medical Technology Association of Australia (MTAA)

17:00 
議長の総括

17:10
1日目終了

 

2日目
 

2016年3月30日

8.30
登録手続き、コーヒー

9.00                       
歓迎の挨拶、スピードネットワーキング

9.05                       
議長の冒頭発言

9:15                       
多剤混合薬と配合剤についての規制

  • EMA's perspective - Clinical Development Guideline for Fixed Dose Combination Drugs
  • Application of FDC guidelines combinations of biologics and to drug-biological product combinations
  • Clarifying application of FDA's requirements regarding FDCs

May Wei Chun Fang, Global Regulatory Strategist, Bayer Healthcare Co Ltd China 

規制面での連携と協調

9:45
パネルディスカッション−成長に向けた弾力性の高い連携の促進

  • Overview, progress and current priorities of the healthcare industry and future public private collaborations
  • Harmonising partnerships and developments and its impact on clinical trial activities
  • Looking into the future approval processes in the drug development industry

May Wei Chun Fang, Global Regulatory Strategist, Bayer Healthcare Co Ltd China 
Lin Hong, Associate Director - Regulatory Affairs, Asia Pacific Russia CIS (APAC) Established Pharmaceuticals, Abbott
Yuko Kikuchi, Senior Director - Asia Regulatory Affairs, Eisai Co Ltd

Handsome Ji, Senior Publishing Team Manager - Worldwide Regulatory Operations, Pfizer

医薬品承認手続きの改善と各種の戦略

10:15
ジェネリック医薬品承認手続きの迅速化:効率化の可能性

  • Generics and Supergenerics regulatory updates and improvements
  • Tapping onto the regulatory environment for generics in Asia
  • Less stringent regulations governing generics approvals
  • Safety and efficacy for generic product: What to expect?

Yuko Kikuchi, Senior Director - Asia Regulatory Affairs, Eisai Co Ltd

10:45
午前の休憩

11:15
医薬品承認手続きの期間短縮に向けた取り組み−薬事申請開始時点での対応の改善

  • Easing regulations governing China-Global Clinical Trials of novel drugs
  • Analysing waiver criteria of "local trial" requirement and Multi-Regional Clinical Trials(MRCT) data acceptance for innovative products
  • Expediting drug approval timelines to reduce impact on costs
  • Key industry insights on how to deal with the various regulatory barriers

Lin Hong, Associate Director - Regulatory Affairs, Asia Pacific Russia CIS (APAC) Established Pharmaceuticals, Abbott

12:00
新薬承認手続きの迅速化を目的としたFDAの505(b)(2)申請

  • Discussing the types of events that can trigger the start of the 180-day exclusivity period
  • Expands the scope of documentation to accelerate for timely NDA Approval
  • Revisions and streamlines submission of patent information

Lingyan Li, Project Manager - Senior Pharmaceutical Affairs Scientist, Tasly Holding Group

12:30 
昼食会

14:00
グループ討論 (45分)

In this session, each roundtable moderator will conduct the discussion in the following format:

  • Moderator to kick-start session with opening overview/idea (5min)
  • Gather audience in small groups and initiate internal discussion based on question/challenges faced (15min)
  • Participants will then summarise findings/solutions by presenting ideas (15min)
  • Moderator to sum up key ideas/strategies with a closing summary (5min)

テーブル1:希少薬開発と中国市場への参入に向けた規制戦略と課題

テーブル2:総合的な医薬品トレーサビリティフレームワークの導入−偽造医薬品による脅威の抑止

電子コモンテクニカルドキュメント (eCTD) と関係書類の提出

14:45
生物製剤と新たな医薬品に対応する申請書類に関する基準の評価

  • Gauging basic principles for evaluation and technical review
  • Categories and criteria for establishing biosimilarity
  • Understanding approval pathways for novel biologics

Wang Xin, Senior Director - International Affairs, China Pharmaceutical Innovation and Research Development Association (PhIRDA)

15:15
午後の休憩

15:45
規制環境が変化するなかでのCTDと関係書類の電子化に向けた取り組み

  • Identifying critical success factors for dossier content and preparing an eCTD submission
  • Agency and regulatory criteria validation and how to comply with content standards
  • Employing the right outsourcing vendor for effective technical validation of dossier submissions

Jannie Ren, Director - China Head of PPLS (Publishing & Product License Support), Pfizer Regulatory Operation

国際共同治験 (MRCT) についてのガイドラインと製品開発

16:15
国際多施設共同治験 (IMCT) のガイドラインに基づく効率的な医薬品開発体制の維持

  • Pacing CTA guideline changes in EU to reduce multiple applications and speed up approval process
  • Ensuring regulatory compliance and smooth clinical trials operation in China
  • Tips in negotiating and tackling regional authorities in varying regulatory environments

May Wei Chun Fang, Global Regulatory Strategist, Bayer Healthcare Co Ltd China           

16:50
議長による閉会の挨拶

17:00 
学会閉幕

 

プレカンファレンス
ワークショップ

2016年3月28日 (月)、09:00 - 16:00

電子コモンテクニカルドキュメント (eCTD) に関するマスタークラス:eCTD技術の進化による世界規模での薬事申請戦略の変化

このワークショップで取り上げられるトピック

  • eCTD入門−eCTDの総合案内
  • 導入に向けた取り組み−アジア地域におけるeCTD申請の現状
  • 中国でのeCTD申請−対応に向けた準備
  • eCTDの要件−世界的な展望と中国での実務
  • eCTDにおけるXML技術
  • eCTDのケーススタディ−技術的な原因による却下の回避

About Your Workshop Team Leader:

Handsome Ji, Senior Publishing Team Manager - Worldwide Regulatory Operations, Pfizer

Handsome leads the Regulatory Operations team which is responsible for publishing both Clinical Study Reports and Regulatory Submissions. This team works on the Clinical Study Reports from Phase 1 to IV and regulatory submissions across all regions during all stage of a product lifecycle. Handsome is highly driven and experienced, with 9+ years operational, project and change management experience within multi-cultured global environments. Handsome holds a bachelor degree in Computer Science from Fudan University.

 

Workshop Session Leaders

Zhanyan ZHANG, Document Services Coordinator, Sanofi
Zhanyan's work mainly focuses on clinical documents format QC, publishing, and other documents services coordinating work. Collaborating with various functions and contributors, the purpose of her job is to ensure submission-readiness of clinical documents for future use, either within the company or submitted to Health Authorities.       

Bruce Sun, Publishing Manager, Pfizer
Bruce Sun holds a bachelors degree in Bioinformatics from Shanghai Jiao Tong University.  He supports publishing activities of both submissions and clinical study reports (CSR) across Pfizer global markets. As a business administrator of submission system suites, he led several projects on centralizing portfolio management, data transparency, cost saving plans, and other e-CTD pilot projects and sequencing in the region.

Xiaofu Luo, Sr. Clinical Publisher, Novo Nordisk (China) Pharmaceutical Co., Ltd
Xiaofu is responsible of clinical publishing of regulatory documents including protocol, clinical trial report (CTR), clinical overview, etc. to secure conformity to electronic Common Technical Document (eCTD) requirements for drug registration. Besides supporting on quality assurance of regulatory documents, he also provides trainings and technical supports on several systems used for e-submission, such as FirstDoc, Liquent InSight and InSight Validator. He has a good understanding of eCTD standards and full experience on electronic publishing. Since 2013, he also expands his expertise on clinical trial transparency to support trial registry and result disclosure.

Kane Song, Publishing Manager, Pfizer
Kane is the publishing Manager, responsible for executing publishing activities for Pfizer global submissions in paper and electronic format to ensure that Pfizer delivers on regulatory submission milestones and maintains commitment to applicable regulatory obligation. He holds Master Degree majoring in Material Science from State University of New York – Stony Brook

Meng Xu, Medical Writing Specialist, Bayer Healthcare
Meng Xu is currently with the Global Medical Writing team of Bayer Healthcare with extensive experience on eCTD readiness. She is responsible for the quality control and coordination of clinical and regulatory documents for eCTD submission. Meng obtained her MS in Applied Biotechnology from Uppsala University, Sweden and her BS in Biological sciences (with a focus on biochemistry and molecular biology) from China Agricultural University.

Meg Wang, Publishing Manager, Pfizer
Meg is the Publishing Manager with enriched skills in publishing eCTD submissions for US, EU, Canada, Swiss and Japan. She also has experience and solicited knowledge in publishing systems and various publishing requirements from competent agencies in EU, US, AfME, EME and Asia.  Meg was previously a drug registration specialist in preparing new drugs along with generic drugs submissions submitted to CFDA in China. She acquired both her master and bachelor degree in China Pharmaceutical University.

 

ポストカンファレンス
ワークショップ

2016年3月31日 (木) 、14:00 - 17:00

市販後医薬品安全性監視についてのマスタークラス

このマスタークラスで取り上げられる主なトピック

  • モジュールの概要、規制、企業組織
  • 市販前医薬品安全性対策の基礎
  • 市販後医薬品安全性監視の基礎
  • 品質システム、検査、監査
  • 審査と情報収集

 

About Your Workshop Team Leader:

Dr J Vijay Venkatraman is a Diabetologist, Drug Safety Physician and Entrepreneur, with an overall experience of 14 years, of which the last 8 years have been in the Pharmacovigilance industry. He holds a MBA degree in Services Management and has been awarded the Fellowship of the Pharmaceutical Information & Pharmacovigilance Association, United Kingdom. He is the Chair of the Pharmacovigilance Council of the Indian Society for Clinical Research, for 2015-17. He is an Affiliate Member of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom.
Dr Vijay founded Oviya MedSafe, a global Pharmacovigilance Consulting & Drug Safety Services company incorporated in Coimbatore, India in 2012 and London, UK in 2014, which has been catering to the international as well as the Indian pharmaceutical industry ever since its inception.
Dr Vijay has been associated with various institutes as a Pharmacovigilance Trainer.

 

* 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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