Global Regulatory Track at DIA's 49th Annual Meeting

CBER Town Hall: Ongoing initiatives, guidances, and regulations

CDER Town Hall: Hot topics in drug development and regulation (part 1)/(part 2)

PMDA Town Hall: Japanese regulation activities and initiatives

What are areas of convergence in regulatory science between CDE-China and CDE-Taiwan?

What is the current regulatory system and government R&D program?

European Town Hall: Implementation of New Safety Legislation

What do stakeholders need to know about the Canada-US #RCC?

What is the current drug supply situation in US, EU and Japan?

What are Canadian approaches to Regulatory Modernization and Int'l Engagement?

Latin America Town Hall: How are LA regulations modeled after and differ from EMA and FDA regulations?

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

Email Preferences | My DIA | Forward to a Friend |

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

Email Preferences | My DIA | Forward to a Friend |

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.