Pharmacoepidemiology and drug safety: a current issue. With the prospect that even more innovative drug therapies will be introduced in the coming years, society is demanding new approaches to comparative risk/benefit evaluation, as well as new concepts. Such evaluations are usually carried out only once the relevant therapies have been used widely in daily practice.
The safety and risk management assessment of different drug therapies is then performed within the framework of observational epidemiological studies (e.g. to establish proof of ‘safety’ and proof of ‘effectiveness’). This is the logical next step after randomized clinical trials, which are designed to provide evidence of a drug’s ‘efficacy’.
During this Pharmacoepidemiology and Drug Safety course, you will learn about typical problems, (such as confounding by indication, or rare side effects) and various pharmacoepidemiologic approaches to dealing with these problems.
The course will cover key issues in pharmacoepidemiologic and drug safety research. Special topics you will discuss include adjustment for confounding, risk detection and management, molecular pharmacoepidemiology and public health. To succesfully participate in this course you will need a medical education, or a degree in biomedical or life sciences.
By the end of this pharmacoepidemiologic and drug safety course, you will be able to:
• Broaden your understanding of pharmacological study design issues and methods
• Explain confounding and other biases, including the indication-related methods of adjusting for confounding
• Distinguish between different methods of drug safety research
• Describe the principles of drug safety and risk management
• Have an overview of the role of pharmacoepidemiological databases
• Understand the essence of molecular pharmacoepidemiology
• Have insight into drug utilization research
• Cohort and case-control study designs
• Confounding and other biases – introduction/new approaches
• Critical appraisal of publications
• Overview and application of pharmacoepidemiologic databases
• The future of electronic health record database research
• The value of individual patient observations in drug safety research
• Continuous evaluation of harm/benefit
• Molecular pharmacoepidemiology
To successfully complete this pharmacoepidemiology and drug safety course, you need to participate actively in the discussion forums and complete the final assignment. You will be able to redo the final assignment once.
To enrol in this course, you need:
• A BSc or Master’s degree in (Bio)medical or Life Sciences
• Preferably to already have taken the course Introduction to Epidemiology
• Preferably to already have taken the course Study Design in Etiologic Research
• Preferably to already have taken the course Clinical Epidemiology
• Sufficient proficiency in English reading and writing
We offer discounts for participants from Low- and Lower-middle-income Countries. Utrecht University and UMC Utrecht employees and students are eligible for a 10% discount. Unfortunately, we don’t offer any scholarships.
No, there aren’t any set times you should be online as it is an asynchronous course. All the web lectures are already pre-recorded. However there will be deadlines each week (during the week as well on weekends). Each week consists of approximately 14 study hours. To experience maximum interaction, we advise you to log in several times per week. Furthermore, you should be aware that the teacher and the e-moderator are off on weekends.
No, this is not possible because the course contains group assignments, so you can’t work ahead. Each week, a new learning unit will be made available. This means that not all the learning units are open simultaneously. Additionally, you can’t catch up on the course because there are deadlines to meet every week.
After enrollment, you will receive a confirmation email. A week before the course officially starts, you will receive an email with more detailed information and planning.
If you have ordered a course and paid immediately, you will receive an email with your login details. Sometimes, this email ends up in your spam folder. If you already have an existing account, simply log in to our learning environment. The course you just ordered will be visible in your account.
If you paid by invoice, you will receive your login credentials as soon as the invoice is paid. If the course is starting soon and you haven’t received your login details, please reach out to us at info@elevatehealth.eu to inquire about the payment status.
When you have completed all the assignments or have finished the exam with a good grade, you will receive an official certificate from Utrecht University. All academic certificates issued by Utrecht University will be sent by mail to the address registered in your account. Since these certificates are official documents, they cannot be sent by email.
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