PDF-May EMACHMPBWP Committee for Medicinal Produc ts for Human Use CHMP Guideline on similar

Author : karlyn-bohler | Published Date : 2014-11-13

europaeu Website wwwemaeuropaeu European Medicines Agency 2014 Reproduction is authorised provided the source is ac knowledged Guideline on similar biological medicinal

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May EMACHMPBWP Committee for Medicinal Produc ts for Human Use CHMP Guideline on similar: Transcript

europaeu Website wwwemaeuropaeu European Medicines Agency 2014 Reproduction is authorised provided the source is ac knowledged Guideline on similar biological medicinal products containing biotechnology derived proteins as active substance quality. Adoption by CHMP for release for consultation24 May 2012 Start of public consultation31 May 2012 End of consultation (deadline for comments)30 November 2012 Revised draft agreed by BMWP and BWPApril 2 V-JSAT2-May-15SUN3-May-15MON4-May-15V-BTUE5-May-15V-L/BV-JWED6-May-15THU7-May-15FRI8-May-15V-L/BV-JSAT9-May-15SUN10-May-15MON11-May-15V-BTUE12-May-15V-L/BV-J13-May-15THU14-May-15FRI15-May-15V-L/BV-JSA . Definitions of Biotechnology . Timeline of Biotechnology . Techniques used in Biotechnology . Who's Who in Biotechnology . 2. How is Biotechnology being used?. . Applications of Biotechnology . Medicines on the market today . Introduction. Lecture 1. Biotechnology. It implies with the use of microorganisms, plants, animals or parts of them for the production of useful compounds.. Pharmaceutical biotechnology. It is concerned as the biotechnological manufacturing of pharmaceutical products. . Biotechnology: the branch of . molecular biology . that studies the use of . microorganisms. to perform specific industrial processes; "biotechnology produced . genetically altered . bacteria that solved the problem" . ETHICS. Set of moral principles governing an individual’s action. Reflects morality (perception of what is right). Essential in making decisions. BIOETHICS. Ethics relating to biology and medicine. Page 2 of 7 EMEA 2005 TABLE OF CONTENTS 1 INTRODUCTION3 11 Regulatory framework3 12 Scope3 13 Need to issue guidance on this emerging issue3 14 Purpose3 2 BASIC PRINCIPLES3 21 Prepublication Copy Uncorrected Proofs THE NATIONAL ACADEMIES 500 FIFTH STREET NW Washington DC 20001 NOTICE The project that is the subject of this report was approved by the Governing Biotechnology?. * . Biotechnology . —the use of biological processes; and . technology. —to solve problems or make useful products. . . *Biotechnology . – using living organisms, or the products of living organisms, for human benefit to make a product or solve a problem.. Kamal Kumar Gupta. Biotechnology -Definition. The application of scientific and engineering principles to the . processing of material . by . biological agents . to provide goods and services. The industrial production of goods and services by processes using biological organisms, systems, and processes,. of. Biotechnology. Dr. Habibur Rahman. Associate Professor. J. N. College, Boko. Introduction . to Biotechnology:. The root words of biotechnology are ancient Greek:• Bios: "life"• . Technikos. : “Skillfully made "tool"• Logos: "Study of," "word," "essence". ● Canary Wharf ● London E14 5EU ● United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa. End of consultation (deadline for comments)31 May 2012 Agreed by BMWP Adopted by CHMP21 February 2013 Date for coming into effect01 September 2013 Keywords Follicle stimulating hormone (FSH), similar . 4. FE314. -. . Biotechnology. Spring . 201. 7. Application of Biotechnology in . Food Industry . Biotechnology . – using living organisms, or the products of living organisms, for human benefit to make a product or solve a problem.

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