InstructorRoyed Training
TypeOnline Course
Price$180 USD / 9900 INR
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Introduction

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About ESAs

Fundamental Training on Erythropoiesis Stimulating Agent

This online course provides therapeutic understanding of Erythropoiesis Stimulating Agent. Course will brief how Erythropoiesis Stimulating Agents approved.

This online course Fundamental Training on Erythropoieis Stimulating Agent course utilizes interactive learning tools to guide each participant through the basics fundamental understanding about the Erythropoieis Stimulating Agent. For example, how it’s manufactured, nomenclature, therapeutic actions etc. Moreover, the course will provide in-depth training on Monoclonal Antibody’s regulatory approval process. Above all, advance strategic discussion course involves the strategic discussion on the Erythropoieis Stimulating Agent ESA biosimilar registration and regulation procedure.

Course Snapshots

  • Course Code: RYD-028
  • Course Title: Fundamental Training on Erythropoiesis Stimulating Agents
  • Type of Course: Online Courses | Microlearning certification course. Therefore the course can be accessed online across anywhere 24×7.
  • Duration: 3 Days
  • Course Certificate : Certificate will be provided at the end of the successful completion of the course.

This Fundamental Online Training on Erythropoiesis Stimulating Agents utilizes interactive learning tools to explain therapeutic action and regulations. Therefore, it will be easy to learn the mechanism of action, therapeutic actions with help of interactive exercises.

Key features of the course

  • 24×7 Online Access. Therefore, access the course anytime from anywhere across globe.
  • Students can download the course materials from dashboard. Hence, it helps them to study offline even after completion of the course.
  • Access the e-lectures, case studies, self assessment modules and practical sessions through personalized web page.
  • Moreover, final examination is online. Hence student can attend the final examination own convenient date and time.

Who should attend this course?

  • Those who want to know about the Fundamental Training on Erythropoiesis Stimulating Agents
  • Even freshers, for example biotechnology, micorbiology graduates who want to make a career in biopahrmceutical industry must learn about Erythropoiesis Stimulating Agents
  • One want to enhance knowledge about the recent innovator Erythropoiesis Stimulating Agents and biosimilar development process.
  • Moreover, business Development, Regulatory Affairs, IPR, strategic management professionals who want to have the detailed understand strategic planning process for registration and regulation of the biopharmaceuticals and biosimilar.

About Erythropoiesis Stimulating Agent

Erythropoiesis-stimulating agents (ESAs) are a class of drugs that stimulate the production of red blood cells (erythrocytes) in the bone marrow. They are primarily used to treat conditions characterized by anemia, where the body does not produce enough red blood cells or hemoglobin, leading to symptoms like fatigue, weakness, and paleness.

Mechanism of Action

ESAs work by mimicking the action of a hormone called erythropoietin (EPO), which is produced by the kidneys in response to low oxygen levels in the blood. Also EPO stimulates the bone marrow to produce more red blood cells. ESAs are synthetic versions of EPO and are used when the body’s natural production of EPO is insufficient or impaired.

Indications

Conditions and situations where ESAs may be prescribed include:

  • Chronic Kidney Disease (CKD): Anemia is a common complication of CKD, and ESAs are often used to increase red blood cell production in these patients.
  • Chemotherapy-Induced Anemia: Cancer patients undergoing chemotherapy often experience anemia as a side effect. ESAs can be used to help manage anemia in these cases.
  • Anemia in Patients with HIV: Some individuals with HIV may develop anemia, and ESAs can be used to address this condition.
  • Anemia in patients with certain chronic diseases: ESAs may be prescribed for anemia associated with conditions like rheumatoid arthritis and inflammatory bowel disease.

Risks associated with ESAs

It’s important to note that the use of ESAs carries some risks and should be carefully monitored by a healthcare provider. Overuse or misuse of ESAs can lead to an increase in red blood cell counts beyond the desired level. Hence, ESAs can be dangerous and increase the risk of serious cardiovascular events.

Additionally, ESAs should not be used in certain situations, such as when anemia is not due to a deficiency in erythropoietin production or when the potential benefits do not outweigh the risks. A healthcare provider will evaluate the individual’s specific condition and make a decision about whether ESAs are an appropriate treatment option.

Section 1
Lecture 1Introduction to Biopharmaceuticals | Biopharma Market | Overview 
Lecture 2Classification of Biopharmaceutical 
Lecture 3Chemical Drugs Vs. Biologic Drugs
Lecture 4Principle of Naming of Biologic 
Lecture 5Class Training - Erythropoiesis-stimulating agent
Lecture 6Erythropoiesis-stimulating agent - Marketed Brands and Also Key Note Points
Lecture 7REMS - ESAs
Lecture 8Aranesp (darbepoetin alfa)
Lecture 9Epogen/Procrit (epoetin alfa)
Section 2Regulatory Approval - Innovator and Biosimilars
Lecture 10Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 11Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 12Purple Book: Significance | Searching | Assignments