Question 11 pts What does ICH stand for? Group of answer choices Information Consistency and

Question 11 pts What does ICH stand for? Group of answer choices Information Consistency and Harmonization International Committee on Health Iowa College of Health International Conference on Harmonization Flag question: Question 2Question 21 pts What are the three high-level document areas covered in the Common Technical Document (CTD) format? Group of answer choices Non-Clinical Clinical CMC/Quality Marketing Flag question: Question 3Question 31 pts The Common Technical Document (CTD) is organized into 6 modules. Group of answer choices True False Flag question: Question 4Question 41 pts In which module would you find a summary of the efficacy results from the clinical studies included in Module 5 which provide the support for a marketing application. Group of answer choices Module 2.6.2 Module 2.7.3 Module 2.7.1 Module 1.11.3 Flag question: Question 5Question 51 pts The ICH provides harmonized guidelines in four different areas. These include Quality, Safety, ______________ and Multidisciplinary. Flag question: Question 6Question 61 pts The ‘e’ in eCTD stands for: Group of answer choices Efficient Electronic Enable Eastern Flag question: Question 7Question 71 pts Per the FDA Guidance for Industry ‘Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications’ as of what date were all NDA and BLA submissions to be submitted in eCTD format? Group of answer choices May 5, 2017 June 30, 2018 January 21, 2021 September 23, 2019 Flag question: Question 8Question 81 pts The CTD format was created by and only for the US FDA. Group of answer choices True False Flag question: Question 9Question 91 pts Which of the following is not a section contained in the US Module 1? Group of answer choices FDA Form 1571 Field Copy Certification Pharmacology Tabulated Summary Request for Waiver of Pediatric Studies Flag question: Question 10Question 101 pts The content of Module 1 is regionally specific. Group of answer choices True False Flag question: Question 11Question 111 pts What is the module number and name where an FDA meeting request would be submitted in the eCTD? View keyboard shortcuts EditViewInsertFormatToolsTable 12pt Paragraph pView keyboard shortcutsAccessibility Checker0 wordsSwitch to the html editorFullscreen Flag question: Question 12Question 121 pts In an initial NDA submission, within which module would you submit your proposed label (USPI)? Group of answer choices 1.14.1 Draft labeling 1.14.2 Final labeling 1.14.3 Listed drug labeling 1.14.4 Investigational drug labeling Flag question: Question 13Question 131 pts Which of the following modules are summarized within Module 2? Group of answer choices Module 1 Module 3 Module 4 Module 5 Flag question: Question 14Question 141 pts eCTD granularity is: View keyboard shortcuts EditViewInsertFormatToolsTable 12pt Paragraph Flag question: Question 15Question 151 pts The Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) should be submitted in which Module? Group of answer choices Module 2.5 Module 5.4 Module 4.2.3.2 Module 5.3.5.3 Flag question: Question 16Question 161 pts What module presents an integrated and critical assessment of the pharmacologic, pharmacokinetic, and toxicologic evaluation of the pharmaceutical, and generally should not exceed 30 pages? Group of answer choices Module 2.5 Clinical Overview Module 2.6.5 Pharmacokinetic Tabulated Summary Module 2.4 Non-clinical Overview Module 2.7.2 Summary of Clinical Pharmacology Studies Flag question: Question 17Question 171 pts Module __________ provides detailed information on the drug substance for your active investigational product. Flag question: Question 18Question 181 pts The Quality Overall Summary (QOS) in Module 2.3 is: Group of answer choices A condensed summary of all quality-related information provided in the CTD. A condensed summary of all safety-related information provided in the CTD. A condensed summary of all efficacy-related information provided in the CTD. A condensed summary of all non-clinical-related information provided in the CTD. Flag question: Question 19Question 191 pts A description of the container-closure system is provided in Module 3 of the CTD. Group of answer choices True False Flag question: Question 20Question 201 pts Please provide one item that you learned this semester that you did not know prior to this class. If you were already knowledgeable of the topics covered you may indicate this. NOTE: There is no wrong answer as long as you provide a response related to the question.

******CLICK ORDER NOW BELOW AND OUR WRITERS WILL WRITE AN ANSWER TO THIS ASSIGNMENT OR ANY OTHER ASSIGNMENT, DISCUSSION, ESSAY, HOMEWORK OR QUESTION YOU MAY HAVE. OUR PAPERS ARE PLAGIARISM FREE*******."