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Topic: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

In the News (Fri 17 Feb 12)

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	NBScience,medical conferences,GCP trainings
		Harmonisation of regulatory requirements was pioneered by the European Community, in the 1980s, as the EC (now the European Union) moved towards the development of a single market for pharmaceuticals.
		The Parties cosponsoring this Conference, represented at the 2nd Steering Committee Meeting in Tokyo, 23-24 October 1990 re-affirmed their commitment to increased international harmonisation, aimed at ensuring that good quality, safe and effective medicines are developed and registered in the most efficient and cost-effective manner.
		The Conference, its preparations and follow-up activities will be conducted in an open and transparent manner and the presence of observers from other regulatory authorities and WHO is welcomed as a means of ensuring that the benefits of progress towards harmonisation can be utilised world-wide.
	www.nbscience.com /gcp.html (2479 words)

	ICH - GCP Guidelines for Clinical Trials (Site not responding. Last check: )
		The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
		The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.
		The objective of such harmonisation is a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health.
	www.vadscorner.com /internet29.html (1217 words)

	International Activities Homepage
		To this end, the FDA's Office of International Programs (OIP) was created to coordinate the Agency's interactions with foreign countries and regulatory counterparts, set priorities for international activities, and provide overall policy guidance on international issues.
		Cooperative Arrangement Between the Food and Drug Administration of the Department of Health and Human Services of the United States of America and the Therapeutic Goods Adminstration of the Department of Health and Aged Care of the Commonwealth of Australia Regarding the Exchange of Information on Current Good Manufacturing Practice Inspections of Human Pharmaceutical Facilities.
		The OECD is a 29 member international group that discusses and develops economic and social policy in such areas as trade, public management, development assistance, and financial markets.
	www.fda.gov /cder/audiences/iact/iachome.htm (2039 words)

	Therapeutic Products Directorate - Wikipedia, the free encyclopedia
		Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States.
		Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy, and quality as required by the Food and Drugs Act and Regulations.
		International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
	en.wikipedia.org /wiki/Therapeutic_Products_Directorate (116 words)

	Notice: International Conference on Harmonisation; Draft Guidance on Q8 .......
		One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies.
		ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States.
		The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America.
	www.pharmcast.com /FederalRegistrar/Yr2005/Feb2005/020705/Q8020905.htm (1044 words)

	International Conference on Harmonisation of Technical... - Wikipedia, the free encyclopedia
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	en.wikipedia.org /wiki/International_Conference_on_Harmonisation_of_Technical... (179 words)

	OMB Watch - - Latest harmonization notices
		The draft guidance is intended to facilitate the nonclinical assessment of the effects of pharmaceuticals on ventricular repolarization and proarrhythmic risk.
		An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
		EuroNCAP began using the ES-2 dummy with the injury criteria specified in EU 96/27/EC in February 2003.
	www.ombwatch.org /article/blogs/entry/170/17 (615 words)

	FDA/CBER Guidances, Guidelines, Points to Consider
		International Conference on Harmonisation (ICH); Draft Guidance: E15 Terminology in Pharmacogenomics - 1/8/2007
		International Conference on Harmonisation (ICH); Draft Guidance: Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC)
		International Conference on Harmonisation (ICH); Guidance for Industry: Granularity Document Annex to M4: Organization of the CTD - 10/18/2005
	www.fda.gov /cber/guidelines.htm (7195 words)

	Tarius - FR News - SUMMARY (Site not responding. Last check: )
		The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs" (the ICH E2C guidance).
		The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
		This guidance is intended to help harmonize collection and submission of postmarketing clinical safety data.
	www.tarius.com /frnews/Summary/04-2314S.htm (163 words)

	eurotherm
		The FDA and other regulatory bodies require not only accurate measurement and storage of room parameters but if the storage medium is electronic then the methods used must comply with 21 CFR Part 11.
		Stability Monitoring of medicinal products is an area also addressed by the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) and the ICH final guidance (agreed Feb 2003), is now being adopted across Europe, Japan and the United States.
		The FDA also states in its 21 CFR part 203 section that manufacturers, authorised distributors of drugs and their representatives shall store and handle all drug samples under conditions that will maintain their stability, integrity and effectiveness, and ensure that the drug samples are free of contamination, deterioration and adulteration.
	www.eurotherm.co.kr /product2/main.php?num=9 (193 words)

	Cover Pages: General SGML/XML Applications
		Annex D. Formal System Identifiers: "This annex states the requirements for the formal definition of notations used in system identifiers to specify access to the storage objects in which entities are stored.
		ICADD is an international nonpartisan consortium of representatives from industry, education, and the disabled community.
		AIP and OCLC have agreed to use this DTD for
	xml.coverpages.org /gen-apps.html (10979 words)

	[No title] (Site not responding. Last check: )
		The Sixth International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
		The Sixth International Conference on Harmonisation (ICH6) took place in Osaka, Japan, from 12 to 15 November 2003.
		The Conference followed the regular meetings of the ICH Steering Committee and its Expert Working Groups earlier in the week where the continued development of new guidances progressed as did work on the implementation of existing guidelines.
	www.ich.org /TxtServer.jser?@_ID=304&@_TEMPLATE=272 (113 words)

	International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed ... (Site not responding. Last check: )
		The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America.
		In the Federal Register of June 14, 2002 (67 FR 40950), the agency made available a draft guidance entitled ``S7B Safety Pharmacology Studies for Assessing the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals'' and invited public comment.
		In June 2004, the ICH Steering Committee agreed that a revised draft guidance entitled ``S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals'' should be made available for public comment.
	www.washingtonwatchdog.org /documents/fr/04/se/13/fr13se04-49.html (784 words)

	The impact of implementation of ICH guidelines in non-ICH countries: Report of a WHO Meeting, Geneva, 13-15 September ... (Site not responding. Last check: )
		This World Health Organization (WHO) report considers issues arising in relation to the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH).
		Lastly, it describes the challenges for WHO in respect of the international harmonisation of drug regulatory activities in the light of the ICH process.
		The report calls for WHO to maintain its position as an observer within the ICH Steering Committee and in the ICH Global Cooperation Group, develop a consultation procedure for assessing the usefulness of new ICH guidelines in non-ICH countries, and establish a mechanism to review and build on ICH guidelines.
	www.eldis.org /static/DOC17277.htm (255 words)

	Research Practitioner (Site not responding. Last check: )
		The International Conference on Harmonisation (ICH) and Its Effect on Clinical Investigation in the United States
		The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use was initiated a decade ago, spear headed by the regulatory agencies of western Europe, Japan and the United States.
		This decade long initiative has brought consistency and standardization to the regulations governing clinical research and to the processes of clinical investigation.
	www.researchpractice.com /cumulative/cum_nd99_2.shtml (165 words)

	Message (Site not responding. Last check: )
		The International Conference on Harmonisation (ICH) is the shortened name for The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
		ICH works to bring together government regulators and drug industry representatives from the U.S., the European Union, and Japan to make the international drug regulatory process more efficient and uniform.
		The ICH has developed the Common Technical Document (CTD) standard, which is an overarching standard document structure for the submission of study data.
	www.cdisc.org /forum/b.asp?m=499 (265 words)

	Instrumentation for complying with The International Conference for Harmonization (ICH)
		Instrumentation for complying with The International Conference for Harmonization (ICH)
		The international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use offers guidance on stability, storage and testing of pharmaceutical product including the handling of residual solvents.
		As organisations have to meet different requirements of different nations, sometimes duplicate testing or different controls leed to ever-rising costs of health care, increasing costs of research and development and public expectation that new products reach the consumer in an efficient process, the ICH looks at harmonizing regulatory requirements.
	www.wessexpower.co.uk /ICH.htm (149 words)

	Publications
		Airbus: Human Factors in the Cockpit, Flight Deck International, November 2001.
		Technical Liability in Satellite Navigation, GPS Procedures conference, Versaille France, October 2000.
		Technical Liability in Satellite Navigation, Flight International Conf, Amsterdam, Sept '99.
	www.aatl.net /publications.htm (879 words)

	International Conference on Harmonisation Documents - Common Technical Documents, Good Manufacturing Practices, etc.
		International Conference on Harmonisation Documents - Common Technical Documents, Good Manufacturing Practices, etc.
		Our collection of International Conference on Harmonisation (ICH) documents is collected from the ICH web site and so represents the version issued by the ICH rather than the version issued by the FDA.
		Organisation of The CTD for the Registration of Pharmaceuticals for Human Use
	www.biologicsconsulting.com /ichdocuments.htm (662 words)

	ICH M2 ESTRI Main Page
		The first Specification developed by the M2 EWG to follow the Step process was the Individual Case Safety Report (ICSR), created as the electronic message for the ICH E2BM step 4 document version 4.4, Data Elements for Transmission of Individual Case Safety Reports.
		The second Specification developed by the M2 EWG was the Electronic Common Technical Document (eCTD)
		The most recent Specification developed by the M2 EWG is the Study Tagging File (STF) Specification.
	estri.ich.org (167 words)

	International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation ... (Site not responding. Last check: )
		International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; Availability
		FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Douglas C. Throckmorton, Center for Drug Evaluation and Research (HFD-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
		The six ICH sponsors are the European Commission, the European Federation of Pharmaceutical Industries Associations, the Japanese Ministry of Health, Labour, and Welfare, the Japanese Pharmaceutical Manufacturers Association, the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA, and the Pharmaceutical Research and Manufacturers of America.
	www.washingtonwatchdog.org /documents/fr/04/se/13/fr13se04-48.html (811 words)

	IFAH
		International Portal on Fod Safety, Animal and Plant Health
		International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
		Online Guide for products and services relevant to the biotechnology and pharmaceutical Industry
	www.ifahsec.org /links/links.htm (123 words)

	IPAC-RS: US & International Activities: ICH Involvement
		IPAC-RS forms working groups to address issues of scientific and regulatory concern in the European Union.
		The IPAC-RS EMEA Working Group reviewed the Committee for Proprietary Medicinal Products’ (CPMP) draft Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurized Metered Dose Inhalers, and submitted comments to the draft on 18 May 2001.
		IPAC-RS also interacts regularly with the European Pharmaceutical Aerosols Group (EPAG).
	www.ipacrs.com /global.html (100 words)

	Sitemap \| ISPE
		As a non-for profit organization, ISPE best serves the industry by creating a forum where industry professionals and regulators can meet and work together on developing new practices and due processes.
		ISPE plays a significant role in promoting innovation and quality within the pharmaceutical industry, making major contributions to safeguarding public health.
		True Stories: What it means to be an ISPE Member - (WMV, 16 MB) (Click to begin, or right-click to download and view later)
	www.ispe.org /cs/root/site_map/sitemap (1354 words)

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