InstructorRoyed Training
TypeOnline Course
Price$390 USD / 18500 INR.
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biopharmaceutical regulatory affairs

Introduction

Course Type

Course Duration

Feature

Eligibility

Who should attend

Certification

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About RA

Course Flow

Biopharmaceutical Regulatory Affairs

Biopharmaceutical regulatory affairs course provides comprehensive training on biopharmaceutical and biosimilar regulation and registration process. Focus is on learning biopharmaceutical R&D, process development, manufacturing and regulatory aspects. This comprehensive training program provides detailed understanding of both innovator biotech and biosimilar (similar biologic) in single course. This advance certification course utilizes interactive online learning tools to provide real life pratical exposure. Therefore, participant will have real life understanding in the steps of the biopharmaceutical (biotech and biosimilar) R&D, process development and manufacturing, commercialization process related strategic planning.

The course can be completed at any pace, allowing the user to stop and start at their leisure. Hence, it is quite convenient to learn on the go.

Course Code: RYD-010

Course Title: Advance Certification in Biopharmaceutical Regulatory Affairs (ACBIODRA).

Online distance learning course. Therefore the course can be accessed online across anywhere 24×7.

1 Month

This Biopharmaceutical Regulatory Affairs online course utilizes interactive learning tools to guide each participant through to understand of the regulatory process of biopharmaceutical products. This online biopharmaceutical training course will focus on understanding regulatory affairs strategic management skills which is required for effective functioning as regulatory personnel who are planning to join to already working in biotech pharmaceutical companies. Indeed, advance simulation in the course will challenge students to apply what they have learned from the course. In addition, there are advance learning tools like interactive exercises, reflection questions, expert live chat which makes the course very interesting.

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. 

Graduation in any discipline. Even the final year student can join the course.

  • Those who want to know about the Biopharmaceutical Regulation and biopharmaceutical registration. Even freshers, for example biotechnology, micorbiology graduates who want to make a career in biopahrmceutical industry can join this course.
  • One want to enhance knowledge about the recent biopharmaceutical regulation and registration process of innovator biomolecules and biosimilar.
  • 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.

 Certificate will be provided at the end of the successful completion of the course.

  1. Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
  2. You will also eligible to receive the course study modules, which you can download by login to your course page.

Career in Biopharmaceutical Regulatory Affairs

The biopharma sector has seen high growth in last 10 years, and most importantly this high growth is going to sustain, even in next 15 years. Due to drying up drug (chemical) pipeline, patent expiry, traditional pharmaceutical companies, who are focussing on small molecules, are now looking for the strategic options to keep up their revenue projection.

Hence, a lot of pharmaceutical companies are diversifying to biopharmaceutical segment. Moreover, many patented biologics are going to expire in coming days, biosimilar is seen as a big scope for pharmaceutical and pharmaceutical companies. Way back in year 1990, total annual revenue of biopharmaceutical industry was has increased from about $4.4 billion. However, biopharma industry reached $275 billion. Most importantly, Biopharmaceutical industry is contributing more than 25 percent of the total pharmaceutical market.

So, there will be huge job demand in biopharmaceutical market. Therefore, biopharma industry seeks skilled person who knows about the basics of  biopharmaceuticals. In addition, advance knowledge about the biopharmaceutical regulation will be required for strategic management, business development and regulatory personnel.

What regulatory job involves?

A career in Biopharmaceutical and Bisomilar Regulatory Affairs is very challenging, but highly rewarding. It opens up lot of opportunities for professionals. But the regulatory job covers a variety of disciplines. Regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.

Important Articles

Biopharma Basics

  • Introduction to Global biopharmaceutical Industry.
  • Biotech Drug Development Process. Overview of the development of a biotech product – clarify the difference between synthetic drugs, biologics and biotech products .
  • Biotech Drugs Classification. Important classes.
  • Detailed understanding on different types biologics. For example, Monoclonal Antibody, Interferon, Erythropoiesis Stimulating Agents and other important biologic.
  • Key Understanding on biotech regulation. Topics include understanding the differences in regulatory philosophy between small molecules and biotech product regulation.
  • Preclinical and Clinical Research Design.

Regulatory Pathway

  • Innovator biopharmaceutical regulation, registration process.
  • Biosimilar Development and regulation. Topics include Introduction to Biosimilar. Meaning of Biosimilar vs. Follow on biologics. Subsequently Difference between biosimilar and generic drugs. Key important issues in Biotech and biosimilar product manufacturing. Insight on biosimilar approval pathway.

Advance Strategic Management 

  • Topics include regulatory submission, approval, production, and the postmarket environment for both drugs and devices. Challenges surrounding the approval and naming of follow-on biologics are addressed. Above all, course discussion covers the stages of a drug pipeline and risk assessment at each marketing authorization stages.
  • Analytical techniques for the Biotech Drugs. Understand the need for using a range of analytical methods in the characterization of biotech product.
  • Global Biotechnology Business. Discussion also covers domestic and International business considerations and international regulatory requirements. Moreover, course provide the access to case studies related to biopahrmaceutical strategic management.
Section 1Fundamental Understanding on Biopahrmaceuticals and Biopahrmaceutical Market
Lecture 1Introduction to Biopharmaceuticals and Biopharmaceutical Market
Lecture 2Classification of Biopharmaceutical 
Lecture 3Chemical Drugs Vs. Biologic Drugs
Lecture 4Principle of Naming of Biologics
Lecture 5Current Trends in Biopharmaceutical Market
Lecture 6Dynamics of Biopharmaceutical Market
Lecture 7Challenges of Biopharmaceutical Industry
Lecture 8Biopharmaceutical Market Segmentation - Global Biologics Market – By Product
Lecture 9Market Share of Different Class of Biopharmaceutical
Lecture 10Blockbuster Biologic - Classifications,  Indications, Global Sales
Lecture 11Market Understanding: Leading Biosimilar Companies
Lecture 12Market Understanding: Top Leading Brands
Section 2Biopahrmaceutical Classification and study on each class
Lecture 13Recombinant protein
Lecture 14Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 15Monoclonal Antibodies : Detailed Understanding
Lecture 16Synthetic Immunomodulator
Lecture 17Production of Monoclonal Antibodies
Lecture 18Cytokines
Lecture 19Interferon
Lecture 20Erythropoiesis-stimulating agent
Section 3Biopahramaceutical Regulatory Pathways
Lecture 21R&D Process & Introduction to discovery, development to commercialization process
Lecture 22Investigational New Drug Application (INDA)
Lecture 23New Drug Application (NDA) 
Lecture 24 Biological Licensing Application (BLA) 
Lecture 25Basic concept and understanding of the Generic Drug
Lecture 26Abbreviated New Drug Application (ANDA) 
Lecture 27Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 28505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 29Purple Book: Significance | Searching | Assignments
Lecture 30Nomenclature of biosimilars
Lecture 31Vaccine development and approval Process
Lecture 32REMS Strategic Planning 
Lecture 33PDUFA For Biologics
Lecture 34Clinical Trials Terminologies 
Lecture 35Advance Learning on 505B2 Pathway
Lecture 36FDA Forms and How to fill the resources
Lecture 37Chemistry, Manufacturing & Controls 
Lecture 38Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 39Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) 
Lecture 40USFDA expedited programs for Pharmaceuticals and Biopharmaceuticals
Section 4Bio-manufacturing
Lecture 41Biosimilar Development Process
Lecture 42Strategic Consideration for Biosimilar Development 
Lecture 43Important Considerations regarding Reference Biologics 
Lecture 44Bio-Manufacturing Process Information
Lecture 45Concept of Interchangeability in Biosimilar Development
Lecture 46Studies required for approval of biosimilar
Lecture 47Demonstrating Biosimilarity: A More Complex Task 
Lecture 48Fermentor | Bioreactor
Section 5Strategic Pathway for Biopharmaceuticals
Section 6Final Examination & Certification