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.

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Clinical Safety and Pharmacovigilance Track at DIA2013

 

Do you know how to recognize the impact of benefit-risk assessment in safety data?

What are the new international standards and terminologies for reporting to EudraVigilance?

How does Risk Communication differ in US and EU?

What is the likelihood ratio test-based signal detection method for FDA’s AERS database?

What is the EMA doing to improve benefit-risk assessment of medicines?

What are the current challenges in monitoring BP through the different indications and in the different trial phases?

What are differences in legislation for risk management between the US, EU and Japan?

How can coding with MedDRA® improve clinical safety data?

What are recent innovations driving patient-focused approach to benefit-risk in Canada?

What is the relevance and application of drug interaction predictive models to clinical development?

How can I obtain higher-quality narrative information from patients through traditional and new media?

How can I generate metrics for the effectiveness and efficiency of a signal detection program?

How do I use social media, mobile apps and patient support programs for pharma and biotech industries?

What is the ongoing international standardization work on ICSR and IDMP?

What are recommendations from projects of the Clinical Trials Transformation Initiative?

How can I anticipate factors that may increase the incidence of drug shortages in the future?

What are the initiatives using electronic health records for drug safety signal detection and evaluation?

How can Herbal-induced Organ Toxicity impact Rx Benefit-risk?

How do I compile a PSUR according to the new EU and ICH guidance?

What are latest developments in pharmacovigilance in the developing countries of Asia and Latin America?

What are the current methods of tracking misuse and abuse of marketed pharmaceuticals?

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

Ranbaxy, Daiichi Sankyo to collaborate to expand business - The Hindu

Drug major Ranbaxy Laboratories and its Japanese parent Daiichi Sankyo on Wednesday announced synergies in Brazil to expand their business in the Latin American nation
.

As part of the collaboration, Ranbaxy will support Daiichi Sankyo’s Brazilian subsidiary, Daiichi Sankyo Brasil Farmaceutica Ltda to enter the branded generics market, in addition to its established business of providing innovative products, Ranbaxy said in a statement.

 

“With the announced synergistic collaboration, the Daiichi Sankyo Group will expand its presence in Brazil through its hybrid business model promoting innovative, branded generic and generic pharmaceuticals,” it added.

Please see link for full article: Ranbaxy, Daiichi Sankyo to collaborate to expand business - The Hindu
 

 

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第10 回 DIA日本年会

 

 

Save the Date: 第10 回 DIA日本年会

11月6月8日

お問い合わせ

 

November 6-8
10th Japan Annual Meeting
TFT, Tokyo

 

 

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。

DIA Japan
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

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Japanese drugmakers, government team up to fight disease

Sign up today to have the latest news in drug development worldwide delivered to your inbox ~ DIA's Global Smartbrief

Japan's government has joined the Bill and Melinda Gates Foundation as well as drugmakers Astellas, Eisai, Daiichi-Sankyo, Shionogi and Takeda to form the Global Health Innovative Technology fund to develop diagnostic tests, drugs and vaccines to fight disease in developing countries. The group will collaborate on research with significant impact, says Dr. Kiyoshi Kurokawa, the fund's chairman. The Japan Daily Press(4/8)

For complete article, http://japandailypress.com/japanese-pharma-companies-to-help-medicine-research-in-developing-countries-0826592

7th Annual Workshop in Japan for Asian New Drug Development ~Register by April 1 to Save

Limited seating available 7th Annual Conference for Asian New Drug Development in Japan – last chance to register. Day 1 Highlights 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) in Japan, the Korea Food and Drug Administration (KFDA) and the Center for Drug Evaluation (CDE) in Taiwan. 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 multiregional clinical trial (MRCT) data. Day 2 Highlights Day two of the conference starts with a session that will discuss one of the key factors influencing development strategy –Market Access. The attendees will particularly focus on differences in practice among countries. An interactive workshop will follow, lead by instructors who have day-to-day experience in new drug development in East Asia. The workshop will be valuable to participants who are planning to file IND/NDA in China, Korea, and Taiwan, who are interested in regulations and clinical development operations in East Asia, or who are working on the front line of clinical development. Overview Download Program Register Online Upcoming events 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 Overview Download Program Register Online

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The 4th Pharmacovigilance Conference in India is now only three days away.

Don’t Miss Your Chance to Exchange Knowledge The 4th Pharmacovigilance Conference in India is now only three days away. Take this opportunity to discuss the latest global challenges in drug safety with professionals worldwide. Professionals attending the two-day conference, to be held in Bangalore from March 8-9, will learn about current global safety reporting requirements for prescription and over-the-counter drugs and discuss new, pragmatic approaches to pharmacovigilance. Other key topics will include the regulatory agency clinical safety and pharmacovigilance inspection program in the US, Europe, and Japan, and identifying best practices for quality assurance in post-marketing pharmacovigilance and clinical safety. Read More View Program Register EXHIBITING OPPORTUNITY Download the application for a tabletop display at the event. Other events of Interest Download the India Calendar of Events Conference Highlights Updates on recently released GPvP Modules by EMA Japanese model of EPPV – a way forward for other Asian countries Challenges in authoring PSUR for generic manufacturers An insight into Drug Induced Liver Injury (DILI) Global regulatory compliance: challenges and the way forward Safety regulations in emerging Middle East region Efficient management of literature searching Enhanced productivity and quality through process re-engineering; case studies Global outsourcing trends in PV – Indian potential and challenges by China, Taiwan, and Latin America RSI management – best practices to safeguard against pitfalls Attrition and manpower stability; KPO perspective Technology-watch against safety hazard of spurious and adulterated drugs Training; A Formality or a Reality – an industry insight Panel discussion: compensation for trial related injuries This Pharmacovigilance Conference is perfect for professionals with experience in clinical safety and who are involved in: Pharmacovigilance Clinical research Risk management Compliance Medical information Regulatory affairs Academia Pharmacology Read More View Program Register To know more, contact Manoj.Trivedi@diaindia.org Thank You to our Media Partner

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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

Japan "best market in the world" for foreign drugmakers

Japan "best market in the world" for foreign drugmakers
Japan is enjoying the benefits of changing the way it reviews, administers and pays for drugs in an effort to spur innovation and address rising costs associated with aging. "For foreign [drug] companies, it's the best market in the world right now," PhRMA representative Ira Wolf said. The country has accelerated the review of new treatments, placed the pricing system under review and set a 30% market share goal for generics. The Economist (tiered subscription model)(2/22)     

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Ex-Director of Office of International Programs Receives Award from FDA (January 15)

Dr. Toshiyoshi Tominaga, former Director of Office of International Programs, has been

recently honored with the U.S. Food and Drug Administration (FDA) Commissioner's Special

Citation Award for his outstanding dedication to fostering collaboration between PMDA and

the FDA and for his superior leadership in the International Conference on Harmonization

(ICH) initiative for many years. This award is bestowed by the FDA Commissioner on a person

(or group) who has made remarkable contributions to FDA’s efforts to better protect and

promote public health. Dr. Tominaga is the first Japanese recipient of this award. The

certificate and commemorative trophy from the FDA Commissioner were presented to him by

Dr. Murray Lumpkin, the FDA Commissioner's Senior Advisor and Representative for Global

Issues.

Taken from PMDA Updates for February 2013.

アジアで開催された新しい薬開発会議

参加受付開始しました 第７回アジア新薬開発カンファレンスのプログラムが閲覧可能となりました。ぜひご覧頂き、３月２５日までの早期割引期間中にお申込ください。特別価格でご参加いただけます。 本カンファレンスでは東アジア各国の規制当局や製薬企業が産官学の立場、そして国を超えて議論を交わし、増加している国際共同治験の試験成績を各国の承認申請においてどのように活用していくべきなのか等の意見交換や、日本においてアジア共同治験により承認を取得した製品を事例に、東アジア開発において未だ残るハードルをどのように越えていくか等の建設的な議論を行います。 また、二日目午後には昨年好評だった「アジア開発実践講座」を開催します。こちらはアジア地域における新薬開発を日常業務とされている方々を招いた参加型実務セッションです。 皆様の積極的なご参加をお待ちしております。 詳細はこちら オンライン登録

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