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Drug Regulatory Agencies In India Pdf Download

 

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Drug Regulatory Agencies In India Pdf Download

 

New product review. ICH's mission is to achieve greater harmonization to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner .PowerPoint Presentation: 58 HISTORY The Need to Harmonise The realization that it was important to have an independent evaluation of medicinal products before they are allowed on the market However in many cases the realization was driven by tragedies, such as that with thalidomide in Europe in the 1960s. For most countries, whether or not they had initiated product registration controls earlier, the 1960s and 1970s saw a rapid increase in laws, regulations and guidelines for reporting and evaluating the data on safety, quality and efficacy of new medicinal productsPowerPoint Presentation: 59 Initiation of ICH Harmonization of regulatory requirements was pioneered by the European Community (EC), in the 1980s , as the EC (now the European Union) moved towards the development of a single market for pharmaceuticals At the same time there were bilateral discussions between Europe, Japan and the US on possibilities for harmonization. The main objective of regulations and good practices is the protection of public health. 1930 The name of the "Food, Drug, and Insecticide Administration" is shortened to "Food and Drug Administration" (FDA) under an agricultural appropriations act.PowerPoint Presentation: 30 Mission The Food and Drug Modernization Act states that the FDA has 4 roles: To promote health by reviewing research and approving new products To ensure foods and drugs are safe and properly labeled To work with other nations to reduce the burden of regulation To cooperate with scientific experts and consumers to effectively carry out these obligationsPowerPoint Presentation: 31 Organization The agency currently has roughly 9,500 full-time employees and is headquartered in Rockville, Maryland. Drug Regulatory Boards 4. .. Kokate Committee Report on FDC 18 Apr 2016 Core Committee on revision of NLEM,2011 02 Feb 2015 Visitor Count :1842981 Update Date :31/08/2016 Notification/Circulars/ Publications Notice and Order 29 Aug 2016 Circulars 03 Aug 2016 Data Bank Data Bank 30 Mar 2016 List of outlet having schedule X license authorized to sell oseltamivir formulation for swine flu (H1N1) 21 May 2015 Help Terms and Conditions Site Map Accessibility Statement Disclaimer Privacy Policy Archives Contact Us This Website belongs to Ministry of Health and Family Welfare,Government of India 2014 All Rights reserved, National Informatics Centre Services Inc. MAIN BODIES: Central Drug Standard Control Organization (CDSCO) Ministry Of Health & Family Welfare (MHFW) Indian Council Of Medical Research (ICMR) Indian Pharmaceutical Association (IPA) Drug Technical Advisory Board (DTAB) Central Drug Testing Laboratory (CDTL) Indian Pharmacopoeia Commission (IPC) National Pharmaceutical Pricing Authority (NPPA) 8INDIA WELL DEFINED DRUG REGULATORY SYSTEM Govt.

 

403 Forbidden . To undertake analytical research in standardization and methodology development of drug.PowerPoint Presentation: 24 COMPOSITION : Indian Pharmacopoeia Commission (IPC) General Body 19 Members Governing Body 10 Members Scientific Body 23 Experts CIPL Lab IPC Secretariat Indian Pharmacopoeia was prepared by Indian Pharmacopoeia Commission(IPC)PowerPoint Presentation: 25 ACTIVITIES AND RESPONSIBILITIES: Development of comprehensive monographs. Analytical quality control of majority of the imported drugs. Manvar College Of Pharmacy DumiyaniContent: Meaning Introduction Key function Agencies in INDIA Agencies in US Agencies in JAPAN Agencies in EU ICH References Content 2MEANING OF DRUG REGULATION: Drug All medicines for internal or external use of human beings or animals and all substances intended to be used for diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals Regulation To regulate means to control something so that it functions properly MEANING OF DRUG REGULATION 3INTRODUCTION:: Drugs play an important role in the health of both people and the economy of a country. Testing of food material like cooking salt for level iodine. Assessment of diseases like level of anemia. Cookies are required to use this site. For more details, view our FAQ.

 

Account Join Now Sign In Premium My Presentations Education Specials RSS Featured Featured Audio Featured Animated Latest Uploads Most Liked Most Viewed Featured Lessons Browse Podcast Featured Featured Audio Featured Animated Latest Uploads Most Liked Most Viewed Categories Facebook App Developers Get your Widget Channels Latest Members PowerPointTemplatesNEW Help & Info About Us Help API FAQ Contact Us Terms and Conditions Privacy Policy Blog Forum What's new? Careers Webinars Why authorSTREAM Feature Tour How it Works PowerPoint to Video & iPod PowerPoint on Blogs PowerPoint to Flash Share Presentations Online Present Live Presentations on iPad Presentation Analytics Branded Channels Video in PPT Greeting Cards Referral authorSTREAM Desktop Buzz on authorSTREAM Follow us on: Go to Application Have a question? Call us at US 210-787-1860 Open Monday to Friday, 8 AM to 6 PM EST 2014 authorSTREAM. Therefore, effective drug regulation is required to ensure the safety, efficacy and quality of drugs as well as accuracy and appropriateness of the drug information available to the public . Preparation and standardization of I.P. The Indian pharmaceutical industry is one of the worlds largest ranking, fourth in terms of volume and thirteenth in terms of value, in the global pharmaceutical market. Seoul, Korea Processing request. The MHLW, which was originally established in 1938, has been in charge of the improvement and promotion of social welfare, social security and public health, and the new organization has the same tasks. Illinois, USA Processing request. ; Size: 124K You will receive a perfect bound, 8.5 x 11 inch, black and white printed copy of this PDF document with a glossy color cover. FAQ Terms of Use Privacy Policy Copyright Contact Us This page was processed by apollo2 in 2.187 seconds . The NIHFW was established on March 9, 1977 by a merger of the National Institute of Health Administration and Education (NIHAE) with the National Institute of Family Planning (NIFP).PowerPoint Presentation: 16 List of Governing Body Members of NIHFW 18 members 1 Chairman (ex-officio) 1 Vice Chairman (ex-officio) 9 Member ( ex-officio) 6 Member 1 Member Secretary (ex-officio)PowerPoint Presentation: 17 ACTIVITIES AND RESPONSIBILITIES : Measuring weight of children to assess the nutritional status.

 

Public Health Service (PHS). Function under the director general of Health Services in the Ministry of Health and Family Welfare.PowerPoint Presentation: 23 FUNCTIONS UNDER TAKEN: Statutory Function : To Act as an Appellate authority. Includes voluntary, FDA requested, and FDA mandated.PowerPoint Presentation: 34 What doesnt FDA regulate? FDA does not regulate: advertising (except for prescription drugs, medical devices, and tobacco products) alcoholic beverages illegal drugs of abuse, health insurance meat and poultry (except for game meats, such as venison, ostrich, and snake)PowerPoint Presentation: 35 The National Institutes of Health traces its roots to 1887, when a one-room laboratory was created within the Marine Hospital Service (MHS) , predecessor agency to the U.S. Quantity: Total Price = $9.99 plus shipping (U.S. Cookies are required to use this site. Collaborate with pharmacopoeias like the BP, USP, JP and International Pharmacopoeia with a view to harmonizing with global standards.PowerPoint Presentation: 26 Drug regulatory agencies in USPowerPoint Presentation: 27 AGENCIES The Food and Drug Administration (FDA) National Institutes of Health (NIH) Centers for Disease Control and Prevention Department of Health and Human Services (DHHS) Fed World - US Government Information National Center for Complementary and Alternative Medicine (NCCAM) National Center for Infectious Diseases (NCID) National Library of Medicine National Science Foundation Office of Disease PreventionPowerPoint Presentation: 28 The Food and Drug Administration (FDA) is an agency within the U.S. s., europe and japan (ich) By: dhadukdharmesh government regulatory agencies By: jocelyngarcia Drug Regulatory AffairsPDF By: ShamonAhmad Drug Regulatory Authorities By: pharma.keerthi drug regulatory affairs By: aSGuest58448 Drug regulatory affairs- The back bone of Pharma iNdustry By: luckylove06021987 Copyright (Intellectual property rights and Drug regulatory affairs) By: kesarwaniarti HCS 490 Week 5 Govt Regulatory Agencies and Impact on Consumer's Choic By: HELPLINE11 Tags Dra *You can't enter more than 5 tags.

 

Drug Information Centers etc. 10 Jun 2016 Medical Device and Diagnostics Alert 19 Feb 2015 Spurious Drugs 19 Feb 2015 Start Stop Approval LIST OF APPROVED DRUG 19 Aug 2016 COPPs granted by CDSCO for Ayurvedic Products 09 Feb 2016 For Consumer Procedure for permission to Import Small Quantities of Drugs For Personal Use 21 May 2015 What's New CLINICAL TRIAL 30 Aug 2016 Notice and Order 29 Aug 2016 Written Confirmation of Export to API to EU 22 Aug 2016 "The SEC Gastroenterology & Hepatology schedule on 29.08.2016 have been cancelled because Technical Committee Meeting is also on same day " 17 Aug 2016 BIOLOGICALS 11 Aug 2016 Start Stop Downloads The Drugs & Cosmetics (Amendment) Act, 2008 and Guidelines ( PDF, 5057KB ) 06 Jul 2015 DOWNLOAD FOR PUBLIC OR STAKE HOLDERS 19 Feb 2015 For Industry Daily Dispatch Details 2016 31 Aug 2016 Checklist for Pre-screening of application 29 Aug 2016 Central Licences Approving Authority Large Volume Parenterals 12 Oct 2015 Blood Bank 28 Aug 2015 Commitee Prof. Number of Pages in PDF File: 30 Keywords: Drugs, Safety, Health, Regulations Open PDF in Browser Download This Paper Date posted: January 27, 2011 Suggested CitationPardeshi, Arvind Alopiprasad, Role and Function of Drug Regulatory Authorities in the Backdrop of Good Governance (January 26, 2011). Your order will ship within 3 business days. KEY FUNCTIONS OF DRUG REGULATORY AGENCY : 5PowerPoint Presentation: The drug regulation consists of: 1. Keep watch on safe manufacturing and handling. 084f2db8c6

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