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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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。

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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

Upcoming DIA Events in Japan, India, China, Latin America and EU

 

Upcoming Events

Japan

3rd Labeling Workshop in Japan
March 16 | Tokyo, Japan
How do patients respond to medicine labels? Find out through real examples and prescribers’ views at the 3rd Labeling Workshop. The session will also share information on the experiences of pharmaceutical companies, medical institutes and pharmacists.

7^th Annual Conference for Asian New Drug Development in Japan
April 15-16| Tokyo, Japan
The conference will provide a forum for exchange of opinions among the regulatory agencies in East Asia 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.

India

6th Regulatory Conference in India
DATE CHANGED to: May 23-24 | Ahmedabad, Gujarat, India
Remaining competitive in the world market despite ever-evolving regulation is the hot topic at the 6th Regulatory Conference in India. The event, entitled "India, the Upcoming Economy: Encouraging Enforcement of Regulations," will bring together the region’s best talent in the pharmaceutical world to understand what the challenges are and how to face them.

China

Training Course: Understanding and Implementing Best Ethics Practices in Clinical Research
April 9-10 | Nanjing, China
This course provides an in-depth, practical, and interactive forum so trainees can better understand the critical aspects of ethical requirements, appropriate patient protection, and the Informed Consent Process throughout clinical trials.

5^th DIA China Annual Meeting
May 12-15 | Beijing
Centered on the theme “Patient Safety – A Sustained Focus from Scientific Ideas to Innovative Medicines”, the meeting will feature more than 40 sessions and 60 exhibitors. Attendees will share knowledge and experience focusing on better public health protection, patient benefits, best practices, and compliance in alignment with science and regulations.

Latin America

Latin American Regulatory Conference (LARC)
May 15-16 | Bogota, Colombia
This event will focus on “Pharma-Co-Vergence” – the act of achieving pharmaceutical regulatory convergence through stakeholders’ collaboration. Attendees will learn how to define the various initiatives related to global regulatory environment and their impact on the access of medicines and future R&D in Latin America.

Europe

7^th European Forum for Qualified Person for Pharmacovigilance (QPPV)
April 17-18 | London, United Kingdom
The 2013 meeting aims to inform QPPVs about any challenges relating to the ongoing release of the new PV legislation by the EMA and provide recommendations on incorporating those changes into the daily life of the QPPV.
QPPV Preconference Workshop
April 16 | London, United Kingdom

Call for Abstracts

Call for Abstracts 7^th Annual Clinical Forum and Exhibition
October 8-9 | Dublin, Ireland
To submit an abstract for the DIA Europe 7^th Annual Clinical Forum click here.
Submission Deadline: April 4

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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Using MRCTs in new drug development

 

DIA Global SmartBrief | Feb 07, 2013

Multiregional clinical trials (MRCTs) in East Asia, including Japan, China, Korea and Taiwan, are now considered one of the promising key strategic options in new drug development. The 7th Annual Conference for Asian New Drug Development, to be held in Tokyo, Japan, from April 15 to 16, will provide a forum for exchange of opinions among regulatory agencies in East Asia about how increasing MRCT data should be used in new drug applications in the region. Read more.