Biopharma Advantage Consulting L L C : 10 books
by FDA, Biopharma Advantage Consulting L.L.C., eRegs And Guides a Biopharma Advantage Consulting L.L.C.
Language: English
Release Date: February 22, 2014
Language: English
Release Date: February 22, 2014
Financial Conflict Of Interest Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) Responsible Prospective Contractors (45 C.F.R. Part 94)
by FDA, eregs and guides a Biopharma Advantage Consulting L.L.C. Company, Biopharma Advantage Consulting L.L.C.
Language: English
Release Date: February 9, 2014
Language: English
Release Date: February 9, 2014
E6 Good Clinical Practice Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application CFR 21-- General Part 11, Electronic Records; Electronic Signatures 21 CFR PART 50 Protection Of Human Subjects 21 CFR Part 54 Financial Disclosure By...
by FDA, Biopharma Advantage Consulting L.L.C., eRegs And Guides a Biopharma Advantage Consulting L.L.C.
Language: English
Release Date: February 22, 2014
Language: English
Release Date: February 22, 2014
ICH - Safety Guidelines S1A – S9 S1A Guideline on the Need for Carcinogenicity Studies S1B Testing for Carcinogenicity of Pharmaceuticals S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals S2(R1) Guidance on Genotoxicity Testing and Data Interpretation...
by FDA, Biopharma Advantage Consulting L.L.C., eRegs And Guides a Biopharma Advantage Consulting L.L.C.
Language: English
Release Date: February 22, 2014
Language: English
Release Date: February 22, 2014
Good Clinical Practice For Your Reference - Book 4 ICH - Clinical Safety E1 - E2F ICH-E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions ICH-E2A Clinical Safety Data Management: Definitions...
by FDA, Biopharma Advantage Consulting L.L.C., eRegs And Guides a Biopharma Advantage Consulting L.L.C.
Language: English
Release Date: February 22, 2014
Language: English
Release Date: February 22, 2014
In this ebook you will find the following guidance documents: ICH Q8 Pharmaceutical Development ICH Q9 Quality Risk Management ICH Q10 Pharmaceutical Quality System
by FDA, Biopharma Advantage Consulting L.L.C., eRegs And Guides Biopharma Advantage Consulting L.L.C.
Language: English
Release Date: February 22, 2014
Language: English
Release Date: February 22, 2014
Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
by FDA, Biopharma Advantage Consulting L.L.C., eRegs And Guides Biopharma Advantage Consulting L.L.C.
Language: English
Release Date: February 22, 2014
Language: English
Release Date: February 22, 2014
PART 600 BIOLOGICAL PRODUCTS: GENERAL PART 601 LICENSING PART 606 CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS PART 607 ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS PART 610 GENERAL BIOLOGICAL PRODUCTS...
by FDA, Biopharma Advantage Consulting L.L.C., eRegs And Guides a Biopharma Advantage Consulting L.L.C.
Language: English
Release Date: February 22, 2014
Language: English
Release Date: February 22, 2014
Good Clinical Practice For Your Reference - Book 5 ICH - Efficacy Guidelines E3 – E15 ICH-E3: Clinical Study Reports ICH-E3 - Structure and Content of Clinical Study Reports ICH-E4: Dose-Response Information to Support Drug Registration ICH-E5: Ethnic Factors in the Acceptability...
by FDA, eregs and guides a Biopharma Advantage L.L.C. Company, Biopharma Advantage Consulting L.L.C.
Language: English
Release Date: February 9, 2014
Language: English
Release Date: February 9, 2014
Good Clinical Practice eRegs & Guides provides a reference to key US FDA Guides and regulations via your electronic reader. An excellent way to access the reference documents on your e-reader. No need to carry paper books and you can search for key terms. In this issue you will find: ...
Good Clinical Practice eRegs & Guides - For Your Reference Book 10
Regulations on: Drug Labeling, Drug Advertising, Drug Marketing, Drug Imprinting, Drug Names, Promotional Materials
Language: English
Release Date: March 23, 2014
Regulations on: Drug Labeling, Drug Advertising, Drug Marketing, Drug Imprinting, Drug Names, Promotional Materials
PART 99 DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES PART 200 GENERAL PART 201 LABELING PART 202 PRESCRIPTION...