InstructorRoyed Training
TypeOnline Course
Price$180 USD / 7500 INR
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Course Code: RYD-021

Course Title: Competency Development Training in Basics of Biopharma.

Course Objective: The objective of this course is to impart basic fundamental know-how and practical understanding about the different types of biopharmaceutical drugs and their regulatory approval process.

Features of the Course:

1. Orientation to practical understanding biopharma and biosimilar products.

2. Simulation to real life biopharma regulatory strategic planning in US market

3. Access to industry case studies.

4. Attend Lectures of all different chapters / study content.

Duration: 1 Week

Course Description

This online course utilizes interactive learning tools to guide each participant through to understand different classes of bio-pharmaceuticals and their regulatory approval process. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

The course can be completed at any pace, allowing the user to stop and start at their leisure.

Who should attend?

  • Biopharmaceutical professionals seeking to improve their skills in the regulatory environment
  • Those moving into regulatory affairs from other areas within a bio-pharmaceutical company (Pharmacists, Clinical Trials, Marketing and others)
  • Anyone wishing to update their knowledge on USFDA regulatory knowledge for biopharma and biosimilars
  • Regulatory Affairs, Registration and Documentation assistants/officers/managers

 

Section 1Basic Fundamental of Biologics Market
Lecture 1Introduction : Biopharmaceuticals
Lecture 2Classification of Biopharmaceutical 
Lecture 3Introduction to Biosimilar 
Lecture 4Chemical Drugs Vs. Biologic Drugs
Lecture 5Principle of Naming of Biologics
Lecture 6Biopharmaceutical Market Overview
Lecture 7Present Encouraging Factors for Biopharmaceutical Industry…
Lecture 8Complexity of biopharma supply chain and operations
Lecture 9Global Biologics Market Classification
Section 2Biologics classes - detailed understanding
Lecture 10Recombinant Proteins
Lecture 11Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 12Monoclonal Antibodies - detailed understanding
Lecture 13Synthetic Immunomodulators
Lecture 14Production of Monoclonal Antibodies
Lecture 15Cytokines
Lecture 16Interferon
Lecture 17Erythropoiesis-stimulating agent
Section 3Biologics - Regulatory Affairs
Lecture 18Biological Licensing Application (BLA) 
Lecture 19Biosimilar Approval process
Lecture 20Vaccine development and approval Process
Lecture 21351(a) Vs. 351(k)
Lecture 22505B2 Pathway
Section 4Biologics manufacturing
Lecture 23Biosimilar Development Process
Lecture 24Strategic Consideration for Biosimilar Development 
Lecture 25Bio-Manufacturing Process Information