What's the best design processes to guide you through the progression of research and development?

Fourteen Steps from Research to Development
June 23 from 1:00PM – 4:30PM in Boston

This tutorial will include discussion of each of the 14 steps used to develop the optimal strategic plan will address the resources and various approaches to tailoring the plan to a sponsor’s specific product under development and obtaining FDA concurrence with the strategic plan. A smooth progression through the preclinical process into early clinical programs will be presented in this half day tutorial targeted to familiarize pivotal staff in startup companies with the required terminology and functions, pharmaceutical/biological companies that have yet to file INDs and those who want to improve their early development approach.

Instructor:
Michael R. Hamrell, PhD,RAC
President
MORIAH Consultants, 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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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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Regulatory Affairs in the news...

In the news...

Regulatory Affairs

First 4 Things to do to Get FDA Approval
New drugs and medical devices cannot be sold to US customers before being approved by the FDA. Read more...

The following events focus on establishing effective regulatory information processes and strategies:

Regulatory Affairs Part I: The IND Phase
April 11-13 | Horsham, PA

European Regulatory Affairs
Begins April 20
Regulatory Information Management
April 24-25 | Philadelphia, PA

Clinical Research in the news...

In the News...

Clinical Research

Madison Researchers Making Major Breakthroughs in Stem Cell Work
Stem cells derived from the skin and blood of blind people are morphing into retina-like balls at UW-Madison. Read more...

Northwestern Study Compares Endovascular Brain Aneurysm Repair Devices
Researchers seek to determine if newly FDA-approved gel-coated coils are more effective than the current standard bare platinum coils for aneurysm treatment. Read more...

DIA’s clinical research events provide insight into clinical research best practices across all medical products.

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

Using Pharmacokinetic and Pharmacodynamic Principles to Enable IND and NDA Submissions
April 16-17 | Bethesda, MD

Creating a Global Clinical Trial Platform for the Protection of Human Subjects
May 15 | Durham, NC