●Editorial | Uchida E | 294-5 |
●Drug development and Medical Research Act in the Netherlands | 297-388 | |
● Clinical Research: Policies and Practices in the Netherlands | Organized and sponsored by the Royal Netherlands Embassy |
297 |
Welcoming remarks | Hamer A | 299 |
Keynote speech: Innovations for clinical research | Kurokawa K | 300-5 |
Policies and Public Private Partnership initiatives for clinical research | Stroeks R | 306-9 |
Clinical research and innovation in the Netherlands | Aken PV | 310-9 |
Climate for innovative drug research in the Netherlands | Henning RH | 320-33 |
High tech early phase drug research in the Netherlands | Cohen A | 334-41 |
Advances in late phase drug development | Grobbee DE | 342-52 |
R&D base in the Netherlands - Big contribution to global R&D in Astellas | Tamura T | 353-58 |
Q&A / Discussion | Moderator: Bleeker T | 359-65 |
● Article and translation | ||
Explanatory review on ethical review system in the Netherlands | Uchida E,Kurihara C | 367-74 |
Wet van 26 februari 1998, houdende regelen inzake medischwetenschappelijk onderzoek met mensen (Wet medischwetenschappelijk onderzoek met mensen) |
(trans. by Uchida E, Kurihara C) |
375-88 |
●The 26th Aso-Kuju Conference on Clinical Pharmacology The Present Conditions and Problems of the Institutional Review Boards(IRBs) | Chairman:Sasaguri T, Ohashi K,Nomoto M,Higuchi S | 389-455 |
Introduction | Sasaguri T | 390-1 |
Questionnaire survey on the institutional review boards in Fukuoka aiming
at the construction of the board member education system |
Sasaguri T,Shibata T, Ueguchi M,et al. |
393-419 |
The activities of IRBs organized in the JACIC member facilities for phase I clinical studies | Iijima H,Momma T,Fukazawa I, et al. |
421-32 |
Japan Association of Site Management Organizations(JASMO) Institutional Review Board(IRB)survey ─ Preliminary results and discussion─ |
Matsushima M,Kobayashi T, Iwakami K,et al. |
433-45 |
Institutional reviews for clinical trials led by the independent physician | Nomoto M | 447-51 |
Learning from the IRB workshop | Inano A | 453 |
Education of IRB members | Ohashi K | 455 |
●Articles | ||
Sales cancellation of Hydrochlorothiazide in Japan | Kuwajima I | 457-66 |
Criticism on the Beers Criteria Japanese version:Premature consensus guideline | Saio T | 467-72 |
●Historical testimony series No.1:Drug Disaster SMON - How the company behave then? | ||
Unrevealed and unsolved aspects of SMON in Japan | Suzuki S | 473-81 |
Chronicle of Quinoform and the SMON disaster | Yamazaki T | 483-508 |
Reflections on SMON:Press conference in Geneva and patients demonstration march in Basel | Beppu H | 509-13 |
●Manual for diagnosis of Adverse Drug Event | Shimizu N | 515-70 |
●Forum | ||
You have got the tools and now you have to use them in a responsible way | Itoh K | 571-4 |
●Instructions for authors [Japanese] & [English] | 575-80 | |
●Editor's note | Kurihara M | 581 |