How does the Japanese regulatory system impact on local and global drug development strategies?

Japan's Regulatory Environment: Overview of the Organization, Processes, Systems and Changes Affecting Pharmaceutical Development:
June 23 from 8:30AM – 12:00PM in Boston

This tutorial is designed for professionals in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan. Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This tutorial will describe the major drivers of the regulatory system, including the PMDA and Ministry of Health, MHLW, regulatory procedures during drug development, the integration of Japan drug development with East Asian and global drug development, orphan drug regulation and J-NDA preparation and review.

Instructor:
Alberto Grignolo, PhD
Corporate Vice President, Global Strategy and Services
PAREXEL Consulting, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

Project/Portfolio Management Track at DIA's 49th Annual Meeting

 

• Effective Diverse Team Collaboration and Management for drug development: East meets West  
• So you want to be a pharma Project Manager?
• What are the requirements for submissions to HTA organizations that affect the drug development team?
• What is the importance of proactively leveraging country selection to support marketing plan objectives?
• How do large and small pharma companies develop orphan drug commercialization strategies?
• Interactive Workshop ~ What are the process and decisions made during Phase 2 drug development?
• Interactive Workshop ~ What are the factors influencing a decision to file for an NDA?What are the key aspects in developing and managing budgets for global drug development projects?
• Where will your project/portfolio management role lead you?
• How do you navigate potential Regulatory land mines in Due Diligence?
• What PM practices are most critical to project success in  biopharma industries?
• How can you influence your organization to create and adopt project management competencies?
• What are financial, resource and planning challenges of Incorporation of Mandatory Language into protocols?
• How can adopting an Adaptive Design Strategy help you Manage Portfolio Risk and Value? Using Innovation to Bridge the Gap Between Strategy and Execution
• How does application of pharmacometrics affect range of drug  development and decision-making activities?
• How are drug development approaches being adopted by companies that develop biosimilars?
• How will Clinical Trials Transformation Initiative’s potential methods apply to QbD?
• What techniques and tools can be used to apply QbD in designing and running clinical development programs?

 

日本における医薬品開発イベント：ラベルとアジア新薬

 

日本における第三ラベリングワークショップ
3月16日|東京、日本
どのように患者が薬のラベルに応えるのですか？第三ラベリングワークショップで実際の例と処方医の見解を通して調べる。セッションでは、製薬会社、医療機関、薬剤師の経験に関する情報を共有することになります。

日本におけるアジア新薬開発のための第7回年次大会
4月15から16|東京、日本
会議では、地域で利用され、新薬申請（NDA）に見直されるべきである多地域臨床試験（MRCT）データを増やす方法については、東アジア地域における規制当局の間での意見交換のためのフォーラムを提供します。建設的な議論はまだ新薬開発に残っているハードルを克服する方法に開催されます。

私のサイトを訪問していただきありがとうございます、素晴らしい一日を過ごす。

詳細については、DIAジャパンにお問い合わせください。
電話番号：+81-3-5575-2130
ファックス：+81-3-3583-1200
メールアドレス：DIAJapan@diajapan.org

Explore the Use of MRCTs in East Asia - April 15-16 Tokyo

Explore the Use of MRCTs in East Asia The program is now available for the 7th Annual Conference for Asian New Drug Development in Japan. Check out which of the exciting sessions will most interest you, then register before March 25 to take advantage of the exclusive members’ only early-bird discount. The conference, to be held at Nakano Sunplaza in Tokyo from April 15-16, will provide a forum for exchange of opinions among the regulatory agencies in East Asia, including the Pharmaceuticals and Medical Devices Agency (PMDA), about how increasing multiregional clinical trial (MRCT) data should be utilized and reviewed in New Drug Applications (NDA) in the region. Constructive discussions will be held on how to overcome the hurdles still remaining in new drug development using case studies of drugs that obtained approvals in Japan based upon East Asia MRCTs. Find out more Register online UPcoming events Who should attend This program will benefit the following individuals: Clinical development professionals Personnel involved in regulatory affairs Personnel at clinical study sites Personnel at CROs and SMOs Early-bird deadline: March 25 Register online or download an application form and forward to: DIA Japan, Nisso 22 Building, 7F, 1-11-10 Azabudai, Minato-ku, Tokyo 106-0041 Japan Tel: +81-3-5575-2130 Fax: +81-3-3583-1200 DIAJapan@diajapan.org Tabletop exhibit opportunity Please contact DIA Japan for details about tabletop exhibits. Tel: +81-3-5575-2130 Fax: +81-3-3583-1200 Email: DIAJapan@diajapan.org Thank you to our media partners

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DIA/FDA Oligonucleotide-based Therapeutics 2012
April 16-18 | Washington, DC

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