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N ISO 9001 : 2008 CERTIFIED INTERNATIONAL B-SCHOOL
SUBJECT:- CLINICAL
PHARMACOLOGY MARKS :80
N.B: 1) All case studies are compulsory.
2) All case studies carry equal marks .
CASE STUDY: 1
Rancip co. wants to discover and develop a new drug costs $ 800-1000 million and takes longer than 12 years. Clinical development development the most important step prior prior to a drug entering the market takes 7 years. years. Each day’s delay in in completing the drug development and launching the product in the market means a revenue loss of $ 1 million. So they appoint Mr. Kate as a project mager and the company expects the company expects the project management techniques to reduce this t his increasing cost and time pressure. Questions:-
Q.1) What are the important responsibili responsibilities ties of Mr. Kate? Q.2) What are the different stages Mr. Kate Kate will use in the Process to set up the project and run it? Q.3) On what elements elements will Mr. Kate focus? Q.4) What are your Suggestions?
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CASE STUDY: 2
IPTA lab discovered one drug on o n white cells and the company wants a clinical trial which is properly planned and executed for assessing assessing the effectiveness e ffectiveness of intervention, company appoints Mr. Simpson as a planner for above because company knows k nows careful planning is required before the collection of data begins for conducting successful clinical research. Now Mr. Simpson appoints two investigators investigators who knows the planning process and to recognize the difficulty encountered in studies with human subjects and planning any clinical trial and attempt to estimate the magnitude of participant’s failure to protocol compliance.
Questions:-
Q.1) What is is a clinical clinical trial? Q.2) What is the process of designing designing and carrying out clinical research? Q.3) Explain the Planning Steps of Mr. Simpson. Q.4) What are the important important considerations to conduct of any type of clinical trial?
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CASE STUDY: 3
Dr. Reddy is a leading pharma company; co mpany; they discover lot of new products pro ducts or drugs in last 20 years. Over the years it it has become more and more necessary necessary to have multidisciplinary specialist specialist approach in planning & Conducting Conducting clinical trials. trials. The team conducting the clinical trial usually consist of the pr incipal investigators, investigators, the t he company investigators and and the clinical research associates associates (CRAS). The clinical Research Coordinators (CRC’S) because Dr. Reddy knows the CRC and CRA are like the two pillars of any critical trial and they are the key ke y members who ensure that the t he data is obtained faster and is clean. Questions:-
Q.1) Define CRC Q.2) Define CRA Q.3) Who can be appointed as a CRC/CRA? Q.4) Elaborate the responsibilities responsibilities of the CRC and and CRA?
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CASE STUDY: 4
Fraud and misconduct in clinical research has received rece ived intense attention in medical field, literature and media in the recent years. Dr. Rajesh was working with Damur India Limited as a chief ch ief nutritionist. nutritionist. He started working on the project of effectiveness of multivitamin multivitamin in improving cognitive cog nitive dysfunction in elderly patients. In 2006, he allegedly produced fraudulent data on the effectiveness of multivitamin multivitamin in improving cognitive co gnitive dysfunction in elderly patients. Suspicion of the data presented arose aro se because of values that were abnormal and a nd a full investigation uncovered the fact fact that the data was concoted. The company came to know know about this when they appointed appo inted Dr. Kunte to investigate the effectiveness of research done by Mr. Rajesh. The investigation study study nurse testified before before the committee enquiring into the matter. matter. A full investigation of his previous publications appeared to prove that he has a long record of similar fabrication and falsifications. falsifications. Company asked Dr. Rajesh to resign.
Questions:-
Q.1) What is the definition of fraud and misconduct misconduct in clinical research? research? Q.2) According to you what are the steps and procedures adopted adopted by Mr. Kunte to investigate investigate fraud? Q.3) What are the penalties penalties you can suggest to Dr. Kunte Kunte for proven fraud and and misconduct? Q.4) Explain the responsibilities responsibilities of Dr. Kunte Kunte as an investigator in the Whole process.
