Will I earn university credit for completing the Specialization?

There will be no degree credit awarded with this course

Is this course really 100% online? Do I need to attend any classes in person?

This course is completely online, so there’s no need to show up to a classroom in person. You can access your lectures, readings and assignments anytime and anywhere via the web or your mobile device.

Can I just enroll in a single course?

Yes! To get started, click the course card that interests you and enroll. You can enroll and complete the course to earn a shareable certificate. When you subscribe to a course that is part of a Specialization, you’re automatically subscribed to the full Specialization. Visit your learner dashboard to track your progress.

Is financial aid available?

Yes. In select learning programs, you can apply for financial aid or a scholarship if you can’t afford the enrollment fee. If fin aid or scholarship is available for your learning program selection, you’ll find a link to apply on the description page.

Can I take the course for free?

No, you cannot take this course for free. When you enroll in the course, you get access to all of the courses in the Specialization, and you earn a certificate when you complete the work. If you cannot afford the fee, you can apply for financial aid.

Spezialisierung für Drug Development and Pharmacoepidemiology

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spezialisierung ist nicht verfügbar in Deutsch (Deutschland)

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Spezialisierung für Drug Development and Pharmacoepidemiology

Use, Safety & Effectiveness of Prescription Drugs. Apply best pharmacoepidemiologic methods to prescription drugs across their lifecycle

Dozenten: Jung-Im Shin

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4-teilige Kursreihe

Befassen Sie sich eingehend mit einem Thema

4.8

(84 Bewertungen)

Stufe Mittel

Empfohlene Erfahrung

4 Wochen zu vervollständigen

unter 10 Stunden pro Woche

Flexibler Zeitplan

In Ihrem eigenen Lerntempo lernen

4-teilige Kursreihe

Befassen Sie sich eingehend mit einem Thema

4.8

(84 Bewertungen)

Stufe Mittel

Empfohlene Erfahrung

4 Wochen zu vervollständigen

unter 10 Stunden pro Woche

Flexibler Zeitplan

In Ihrem eigenen Lerntempo lernen

Was Sie lernen werden

Articulate core principles and analytic approaches used to quantify the use, safety and effectiveness of prescription drugs after market approval
Contribute to and critically evaluate study designs and methodologies examining product use, safety and effectiveness
Understand the complexity of optimizing the value of pharmacotherapies in clinical practice and the incentives and roles of various stakeholders

Kompetenzen, die Sie erwerben

Kategorie: Patient Safety
Kategorie: Clinical Research
Kategorie: Drug Development
Kategorie: Pharmaceuticals
Kategorie: Patient Education And Counseling
Kategorie: Medical Prescription
Kategorie: Medical Devices
Kategorie: Medication Therapy Management
Kategorie: Program Evaluation
Kategorie: Epidemiology
Kategorie: Data Analysis
Kategorie: Pre-Clinical Development
Kategorie: Pharmacotherapy
Kategorie: Utilization Management
Kategorie: Pharmacology
Kategorie: Statistical Analysis
Kategorie: Clinical Trials
Kategorie: Public Health
Kategorie: Health Policy
Kategorie: Value-Based Care

Wichtige Details

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Unterrichtet in Englisch

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Spezialisierung - 4 Kursreihen

Pharmacoepidemiology is a scientific discipline that uses epidemiological methods to evaluate the use, benefits and risks of drugs, devices and biologicals. It focuses on observational research methods that use data which are generated in the usual care of patients. This four-course specialization teaches:

The drug development process
Methods for assessing use of products with real-world data
Observational methods for effectiveness evaluation
Methods for pharmacovigilance and safety evaluation

The course directors provide insights from the field to inform trainees and professionals seeking to improve the quality and safety of medication use. This course is ideally suited for early and mid-career medicine, pharmacy, and public health professionals who wish to expand their knowledge of pharmacoepidemiology and drug safety to inform their work in academic, regulatory, or industry settings.

Praktisches Lernprojekt

Pillar #1: Drug Development - From Bench to Bedside

KURS 15 Stunden

Was Sie lernen werden

Describe the drug development approval process and regulatory agencies’ role in approval process
Examine the role of pharmacoepidemiology throughout the drug development process and informing regulatory, clinical and policy decisions
Identify essential tools and resources to conduct pharmacoepidemiologic studies

Kompetenzen, die Sie erwerben

Kategorie: Drug Development

Kategorie: Clinical Trials

Kategorie: Epidemiology

Kategorie: Regulatory Compliance

Kategorie: Pre-Clinical Development

Kategorie: Medical Devices

Kategorie: Pharmacology

Kategorie: Pharmaceuticals

Kategorie: Clinical Research

Kategorie: Health Policy

Kategorie: Statistical Analysis

Kategorie: Data Collection

Pillar #2: Drug Utilization - Drivers and Consequences

KURS 26 Stunden

Was Sie lernen werden

To explore how drug utilization research provides critical information regarding patterns, quality and determinants of prescription drug utilization
To assess methods for improving drug utilization, including value-based insurance, audit and feedback, patient education, and medication management.
To reinforce key concepts relevant to drug utilization through case studies including antibiotics, opioids, anticoagulants and generic drugs

Kompetenzen, die Sie erwerben

Kategorie: Pharmacotherapy

Kategorie: Medication Therapy Management

Kategorie: Pharmaceuticals

Kategorie: Epidemiology

Kategorie: Research Design

Kategorie: Statistical Analysis

Kategorie: Patient Education And Counseling

Kategorie: Medical Prescription

Kategorie: Utilization Management

Kategorie: Health Policy

Kategorie: Value-Based Care

Kategorie: Pharmacology

Kategorie: Patient Safety

Kategorie: Clinical Research

Pillar #3: Drug Effectiveness - Real-World Evidence

KURS 36 Stunden

Was Sie lernen werden

Differentiate efficacy and effectiveness research and identify stakeholders who value this research in public health and regulatory decision-making.
Recognize the strengths and limitations of epidemiology study designs, including cohort, case-control, case-cohort, and self-controlled designs.
Use best methods of study design and analysis to control for confounding and biases in observational research

Kompetenzen, die Sie erwerben

Kategorie: Epidemiology

Kategorie: Clinical Research

Kategorie: Statistical Methods

Kategorie: Clinical Trials

Kategorie: Pharmacology

Kategorie: Scientific Methods

Kategorie: Regression Analysis

Kategorie: Real Time Data

Kategorie: Analytical Skills

Kategorie: Data Collection

Pillar #4: Drug Safety - Pharmacovigilance

KURS 45 Stunden

Was Sie lernen werden

Explain the types of pharmacovigilance, including with their limitations and strengths, and key surveillance systems in the US and globally
Describe US regulatory requirements for drug safety, including phase 4 post-marketing studies
Recognize real-world impact of drug safety research and its role in shaping regulatory actions and policies