ICH Project ICH6 Held
November 21, 2003
ICH6 Concludes with Approximately 1,850 Participants
ICH6, held under the theme “New Horizons and Future Challenges,” took place over four days from November 12 to 15 at the Osaka International Convention Center in Nakanoshima, Kita Ward, Osaka City. Approximately 1,550 people from 44 countries,approximately 300 exhibitors from four countries—for a total of about 1,850 participants.
During the satellite session on the first day—a symposium between the Global Cooperation Group (GCG) and non-ICH regions—titled “Partnerships in Harmonization,” representatives from non-ICH regions such as SADC, PANDRH, APEC, and ASEAN presented reports and exchanged views.In addition, a meeting of the MedDRA Users’ Group was held, and a workshop on gene therapy as a new technology addressed technical challenges and issues in clinical trials.
On the second day, the opening plenary session was held. Following a welcome address by Mr. Mori, Vice Minister of Health, Labor and Welfare, Mr. Nagayama, Chairman of the JPMA, delivered a speech in English titled “New Era of Drug Discovery and Key Issues for the Pharmaceutical Industry” on behalf of the host country.He noted that in Japan, the development of infrastructure for pharmaceutical R&D—particularly the improvement of the clinical trial environment—is an urgent priority, and that the country is striving to realize efficient, high-quality clinical trials. He also emphasized that“In Japan, efforts to promote life sciences and biotechnology as strategic national science and technology fields are gaining full momentum. We must continue our efforts to create innovative new drugs and deliver them to patients around the world,” he emphasized.
Mr. Nagayama, Chairman of the JPMA, delivering his lecture
Following this, Dr. Lumpkin of the FDA, Dr. Krall of PhRMA, Dr. Weissenverg of the EU, and Prof. Herrling of EFPIA delivered presentations on behalf of their respective ICH parties regarding technological innovation in pharmaceutical development and ongoing efforts toward international regulatory harmonization.
On the third day, topic-specific breakout sessions were held, featuring presentations and discussions on various topics based on the content reviewed and agreed upon at the expert meeting and steering committee held in Osaka prior to ICH-6.
On the final day, the 15th, a closing plenary session was held,during which the ICH GCG’s summary was presented, and discussions were held on “Future Challenges,” including forecasts for the future of drug development driven by emerging technologies and the future direction of the ICH. Given that international coordination will become increasingly necessary due to the emergence of new technologies and other factors, it was reaffirmed that the ICH will continue to play a vital role, and ICH6 concluded successfully.
Closing Plenary Session