A TEXT BOOK ON CLINICAL TRIALS AND REGULATORY AFFAIRS

IV BTech Biotechnology JNTUH Syllabus of Clinical Trials and Regulatory Affairs

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UNIT-I: Licensing authorities-roles and responsibilities,ICH GCP,FDA, EU Clinical Trial Directive, Data Protection Act & Regulati...

UNIT I

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UNIT-I: Licensing authorities-roles and responsibilities ICH GCP ( Note : throughout the syllabus, in some topics you will fi...
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Zahoorullah S MD
1)BTech(Biotech)passedout in 2002-2006 First batch in AndhraPradesh,MTech(Biotech)From IST,JNTU Campus2009 passedout, 2)6thRank in PGECET2007,28th Rank in IICT DBI2006 Exam,3rd Rank in HCU MTech Bioinformatics Exam2006 3)Subjects Taught are Biopharmaceutical Technology,Molecular Pathogenesis,Protein Engg,Genomics &Proteomics,Genetics,Environmental Studies,Biodiversity &Intellectual Property Rights,Cell Biology,Microbiology.Nanobiotechnology,Bioinformatics,Chemical Engineering subjectsHeat Transfer in Bioprocess,Bioprocess Engineering,Instrumentation & Process Control,Biochemical Reaction Engineering I & Biochemical Reaction Engineering II,Mass Transfer & Seperation, and 4)software Programmer J2SE,Java Scrit,C,C++,HTML,XML. 5)Cracked IT Entrance tests for CTS,TCS,WIPRO & Others ,GRE,TOEFL test patterns for IIIT.
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