PMDA Third International Symposium on Biologics (2009) >>

PMDA First International Symposium on Biologics (2008) >>

PMDA First International Symposium on Biologics (2007) >>

Background: The First International Symposium on Biologics has been organized to meet the demand of professional audience due to the novelty of importance of the subject of biologics.

PMDA introduction: In his written follow-up remarks, the Director of the Office of Biologics, PMDA, firstly apologized for having many candidates to participate eventually turned down due to the constrains of the event space. Further, the work of the Office of Biologics - established in 2005 along with the new PMDA structure, was reviewed with two principle conclusions: the workload of the office exceeded what was initially thought and the necessity to double the number of staff reviewer over the next three years as recently was proposed to the Government.

Additionally, it was reported that the symposium has been attended by 228 participants, of which 74% with manufacturing and sales of pharmaceuticals background. Nearly two-thirds of attendees found the presentations "somewhat informative". Deemed as successful, the symposium is expected to be organized in the next years as well.

Presentations: The symposium was held in Tokyo (on February 15, 2007, in Hotel & Hall Komaba-Eminence in Tokyo).  Seven key presentations were made reflecting the views of PMDA, EMEA, FDA and industry.

The keynote lecture entitled "Some Aspects of Development, Evaluation and Control of Biologics in Japan" was delivered by a Senior Advisor to PMDA.

Keynote lecture    | ...more       

Background: The Generics Asia Conference was held in November 2006 in Singapore.

Presentations: The Generics Asia was held with participation of representatives from generic industry in the Asia under the slogan "Partnerships for today. Strategies for tomorrow".

The keynote lecture entitled "Japan's Healthcare System and Generic Drug Industry" was delivered by a Secretary General of the Japan Generic Pharmaceutical Manufacturers Association (JGPMA).

Keynote lecture       

Background: The Asia-Pacific Economic Cooperation (APEC) was established as an economic forum for a group of Pacific Rim countries to discuss matters on regional economy, cooperation, trade and investment. The initiative to create a project dedicated to issues of pharmaceutical (including medical devices) regulatory sciences coincided with the  adoption of the ICH Guideline on Ethnic Factors in the Acceptability of Foreign Clinical Data in 1998 and world-wide initiation of bridging clinical trials.

PMDA introduction: The project was proposed to the Industry, Science and Technology Working Group (ISTWG) of APEC by Chinese Taipei in March 1998 and was approved in August that year. The overall objective of this project is to establish an APEC network of pharmaceutical regulatory science solving common problems and for a better mutual understanding on new drug regulatory issues. Upon approval, a series of APEC Symposia were held. The first time was at Taipei in 2000, and has been held continuously every year afterwards, at Taipei, Tokyo, Taipei, Seoul and Taipei in 2001, 2002, 2003, 2004 and 2005, respectively. Initial work plan is to formulate the guideline and Q&A and coordinate workshop and seminar in relation to bridging study. The first three meetings intended to facilitate the registration of drugs by establishing a framework for evaluating the impact of ethnic factors in drug’s effect on different populations. Since APEC 2003, the theme was enlarged from “bridging study” to “regulatory communication” in response to the implementation of International Conference on Harmonization (ICH) guidelines in the APEC. This project allows extrapolation of foreign clinical data on new region, bringing safe and effective new drugs to APEC economies effectively via the improvement of regulatory science, and ultimately making contributions to global new drug development. With these achievements, this project was endorsed by the ICH, Global Cooperation Group as an important regional initiative in regulatory communication. With more and more multi-national collaborative clinical studies conducted in Asian countries as part of global development, it is the time to expand the focus from “bridging study” to “global development and cooperation among Asian economies”. As appeared in the Welcome Message of the 2002 meeting in Japan, “Global simultaneous development and introduction of innovative drugs is no longer a dream” and the dream is now becoming the reality. Therefore, we can open up the possibilities of the new reality with more conviction.

Presentations: The APEC 2006 symposium was held in Tokyo (October 12-13, 2006 at Royal Park Hotel), presentations were made by regulators and industry and panel discussion was carried out related to the issues of global development and cooperation among Asian economies.

Key presentations    | ...more