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RIS 2012-11, NRC Staff Position on Applying Boiling Water Reactor
Sep 26, 2012 ... NRC REGULATORY ISSUE SUMMARY 2012-11 .... Note: NRC generic communications may be found on the NRC public Web site, ... PMDA. OIS. NAME . MEvans. WRuland. NHilton. *LCasey for. CAder ... 06/07 /12. 09/11/12.
[ ML11251A233.pdf - Read/Download File

The Rulemaking Process. - NRC
Date Approved: 07/22/2013. For the latest ..... 11. Delegates to the Director of NRR the authority to approve the following: .... 10. Posts rulemaking documents on the Federal Government's rulemaking Web site, ..... Burdens,” June 22, 2012. ... Office of the Chief Financial Officer, Memorandum to PMDA Directors in the Office of.
[ ML13205A400.pdf - Read/Download File

Report on interactions between the Japanese Ministry of Health
[email protected] Website www.ema.europa.eu ... 30 July 2012 ... ( MHLW)/Pharmaceuticals and Medical Devices Agency (PMDA) and the European ..... M ay-10 Jul-10. Sep-10 Nov-10 Jan-11 M ar-11. M ay-11 Jul-11. N u m b er o.
[ WC500130446.pdf - Read/Download File

Summer 2012 - US Pharmacopeial Convention
Sep 17, 2012 ... headquarters in Rockville, Md., on November 7–8, 2012, to discuss the concepts in the .... tinuing as USP welcomes PMDA's Dr. Eriko Fukuda. ..... The growing demand for PE web courses is a major driver for developing ...
[ standard_summer2012-web.pdf - Read/Download File

Activity Summary of the 11th Term (April 2012 – March 2014
As Study Group 1, GCP Division, we set the Year 2012 – Year 2013 theme of “ How a .... Assurance in Clinical Studies –JSQA's Views − (11C07), and formulate a ..... PMDA [Japan and overseas] (128 reports), which were reported by members of the ... released the contents on the JSQA website throughout the year.
[ GCP_ActivitySummaryOfThe11thTerm_E.pdf - Read/Download File

When should in vivo transporter- mediated drug-drug - FDA
Mar 7, 2015 ... Investigation of Drug Interactions (2012) ... .ema.europa.eu/docs/en_GB/ document_library/Scientific_guideline/2012/07/WC500129606 .... Page 11 .... EMA and PMDA ... FDA Drug Development and Drug Interaction Website:.
[ UCM439860.pdf - Read/Download File

Focus on 2013 - CIRS
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013. 2004 2005 2006 .... 11. NASs) but PMDA has seen a decrease (11 vs. 5 NASs) from. 2004-2008 to 2009- 2013. Approval time by ..... 01/07/2013. Erivedge ..... Website: www.cirsci.org.
[ CIRS_R&D_Briefing_54_ ICH_approval_times_2004-2013_22apr2014.pdf - Read/Download File

New Drug Approvals in ICH countries 2005-2014 - CIRS - The
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014. 2005 2006 ... FDA and PMDA NAS median approval times converged in 2005-2014, with. PMDA the ..... Expedited reviews were used for 57%, 54% and 11% reviews at FDA, PMDA and EMA, respectively. ..... Gilead Sciences Inc 23/07/2014 Expedited Orphan. Y. Y.
[ CIRS_R&D_57_ICH_ approval_ times_2005-2014_ 06072015.pdf - Read/Download File

PMDA Updates
Dec 4, 2014 ... These documents can be found on the PMDA website (Please check the news ... DIA Japan 2014: The 11th Annual Meeting (November 16 to 18) ... following the first in 2012, and the second in 2013. 8. .... http://www.ema.europa.eu/ema/index. jsp?curl=pages/news_and_events/events/2011/07/event_det.
[ 000197869.pdf - Read/Download File

PMDA Updates
Nov 3, 2015 ... PMDA training to the exchange group from Henan Food and Drug ... information about English version of review reports on PMDA web site. ... A formal PASS scheme was started in 2012 aiming to identify or quantify a ... /index.jsp?curl= pages/news_and_events/news/2015/07/news_detail_ ... October 11-13.
[ 000207029.pdf - Read/Download File

Download PDF - Plos
Sep 23, 2013 ... available Pharmaceuticals and Medical Devices Agency (PMDA) website, and by disclosure requests for the dossier of losartan to the. Ministry of Health ..... 19, 2012. 11. Elliott WJ (1996) Higher incidence of discontinuation of angiotensin converting enzyme ... jp/01/07_publication/07_image/koatsufinal.pdf.
[ journal.pone.0075027.PDF - Read/Download File

Regulatory Newsletter July - September 2015 - CROMSOURCE
Sep 28, 2015 ... CROMSOURCE website. We hope .... On 11 August 2015, EMA released for public consultation the draft of a revised version of this guideline.
[ Regulatory_Newsletter_Jul-Sep_2015_.pdf - Read/Download File

Priorit Medicines for Elderly - World Health Organization
Jul 3, 2013 ... Figure 7.3.1). In 2010, about 11% of the population worldwide was aged 60 and over. ..... Ann Oncol 2012 Nov 7.33. In an attempt .... This is also the case in many elderly, as shown in a study by van Geffen et al. using an internet-based .... FDA, EMA and the Japanese regulatory authority (PMDA). In 2010, a ...
[ BP7_3Elderly.pdf - Read/Download File

Get PDF (501K) - Wiley Online Library
and/or covered CDx, with only 11 having an approved CDx. Four. PGBMs had a .... Japanese drug approval data from the PMDA website's section on new drug .... 2012;37:617–619. 2. ... 07/WC500108672.pdf (accessed 23 Septem- ber 2013 ) ...
[ jcpt12129.pdf - Read/Download File

Annual Report 2015 (PDF 2666KB) - Takara Bio Inc.
Apr 1, 2002 ... 07. Business Strategies. At a Glance. Global Business Expansion. Research and Development. The Center for Gene and Cell Processing. Message from the President. 11. 11. 13. 15 ... 2012. 2014. 2015. Developed a highly efficient retroviral ..... the PMDA and Phase I clinical trial (investigator initiated trial) ...
[ 2015_AR_e.pdf - Read/Download File

Approval of Medical Devices - Library of Congress
Sep 8, 2014 ... 11 European Commission, DG Enterprise, Guidelines for the ... 8, July 2001, http:/ /ec.europa.eu/health/medical-devices/files/meddev/2_2_4-1part1_07-2001_en. pdf. ... Regulation for In Vitro Diagnostic Medical Devices, COM (2012) 541 final, ..... 97 Japan PMDA Medical Device Approval and Certification, ...
[ approval-of-medical-devices.pdf - Read/Download File

7th International Workshop on Regulatory Requirements and
DDI guideline in 2012, a new food-drug interaction guideline is currently in ... update of the EMA, FDA and PMDA DDI guidelines providing explicit ... 07:30 p.m. ... 10:45 – 11:15 a.m. .... web site, if you arrange the travel yourself. POSTER  ...
[ 1180056_BRO_DDI_Workshop_2016_2ndA.pdf - Read/Download File

Project Overview - IMI2 - ADAPT-SMART
11. 3.1 Work plan — Work packages, deliverables and milestones . .... PMDA. Pharmaceuticals and Medical Devices Agency (Japan). R&D. Research ..... Pharmacol Ther 2012;91:426-437. 3. .... Building and maintaining a public project website (D4.04); .... Appropriate market utilisation for the targeted patient group ( D2.07).
[ ProjectOverview-IMI2-ADAPTSMART.pdf - Read/Download File

2013 Annual Report - Critical Path Institute
JAN 29. 2013. FEB 21. 2013. MAR 6-8. 2013. MAY 23. 2013. JULY 10. 2013. DEC 6. 2012 .... as smart phones, tablet computers, the web, or interactive voice response systems. ... Agency (PMDA) to accept PSTC's new kidney biomarkers. ... C-Path announces the availability of its database of 11 industry-sponsored.
[ 2013-critical-path-institute-annual-report.pdf - Read/Download File

16th - International Society for Infectious Diseases
Apr 5, 2014 ... SARS in 2003 and another new coronavirus in 2012. ❍ A FREE ... its own website, Twitter feed, and Facebook pages. ❍ ALL OF THE ..... She has 11 publica- ..... 07:45 to 08:45hrs. ..... J. V. de Oliveira2, P. M. D. A. Zanotto2,.
[ 16thICID_FinalProgram.pdf - Read/Download File

Sanofi fights against counterfeit medecines
Advice for patients on the Internet and when traveling. »What are ... About 3,000 products were analyzed in 2012 with 200 confirmed cases of .... In 2012, 100 countries .... Page 11 ..... Approved by: MSNA, EMA, FDA, PMDA (France, EUROPE,.
[ 33151_DP_Counterfeit.pdf - Read/Download File

View - enigma
Apr 15, 2012 ... VOLUME 44 | NUMBER 5 | MAY 2012 NATURE GENETICS ... tive ability11–13. ..... Note: Supplementary information is available on the Nature Genetics website. ... M.W. received honoraria from PMDA/ the Japanese. Ministry ...
[ ENIGMA-GWAS-Nature-Genetics-Stein-J-2012.pdf - Read/Download File

Annual Report 2015 (PDF 2666KB) - Takara Bio Inc.
Apr 1, 2002 ... 07. Business Strategies. At a Glance. Global Business Expansion. Research and Development. The Center for Gene and Cell Processing. Message from the President. 11. 11. 13. 15 ... 2012. 2014. 2015. Developed a highly efficient retroviral ..... the PMDA and Phase I clinical trial (investigator initiated trial) ...
[ 2015_AR_e.pdf - Read/Download File

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