This course will provide you with a broad understanding and guidance documents of the application of biostatistics in a regulatory context. The topics include are basic study design, target population, comparison groups, and endpoints. See More: https://bit.ly/2ounaEJ

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Certi cate In Biostatistics For Medical
Product Regulation
( 9 REVIEWS ) 589 STUDENTS
What can you use to nd out the similarities and differences between medical products? The answer
is statistic or more …
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FREE
1 YEAR
LEVEL 2
COURSE BADGE
COURSE CERTIFICATE
14NUMBER OF UNITS
0NUMBER OF QUIZZES
4 HOURS, 20 MINUTES
HOME CURRICULUM REVIEWS
What can you use to nd out the similarities and differences between medical products? The answer
is statistic or more speci cally biostatistics.
This course will provide you with a broad understanding and guidance documents of the application
of biostatistics in a regulatory context. The topics include are basic study design, target population,
comparison groups, and endpoints. You will be able to addresses analysis issues including issues of
missing data and informative censoring.
Assessment
This course does not involve any written exams. Students need to answer 5 assignment questions to
complete the course, the answers will be in the form of written work in pdf or word. Students can
write the answers in their own time. Each answer needs to be 200 words (1 Page). Once the answers
are submitted, the tutor will check and assess the work.
Certification
Edukite courses are free to study. To successfully complete a course you must submit all the
assignment of the course as part of the assessment. Upon successful completion of a course, you can
choose to make your achievement formal by obtaining your Certi cate at a cost of £49.
Having an Of cial Edukite Certi cation is a great way to celebrate and share your success. You can:
Add the certi cate to your CV or resume and brighten up your career
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Course Credit: JHSPH Open
Lecture 1 Biostatistics in Medical Product Regulation Introduction ( Day ) 00:15:00
Lecture 2 Study Designs, Objectives, Hypotheses (Foulkes) 00:20:00
Lecture 3 Study Populations (Day) 00:10:00
Lecture 4 Study Designs (Day) 00:35:00
Lecture 5 Comparison Control Groups (Foulkes) 00:20:00
Lecture 6 Outcomes, Surrogates, Composite Endpoints (Day) 00:30:00
Lecture 7 Analysis Issues, ITT, Post-Hoc, and Subgroups (Day) 00:25:00
Lecture 8 Multiplicity, Missing Data (Foulkes) 00:25:00
Lecture 9 Non-Inferiority Speci cation of Delta (Foulkes) 00:20:00
Lecture 10 Multi-Regional Studies and Bridging Studies (Day) 00:15:00
Lecture 11 Interim Monitoring (Foulkes) 00:30:00
Lecture 12 Course Summary and Review (Foulkes) 00:15:00
Assessment
Submit Your Assignment 00:00:00
Certi cation 00:00:00
COURSE CURRICULUM

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COURSE REVIEWS
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