InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$490 USD / 27500 INR.
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biopharmaceutical regulatory affairs course



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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 a single course. This advanced certification course utilizes interactive online learning tools to provide real life practical exposure. Therefore, participants 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 is self paced learning. Therefore, the course can be accessed 24×7, 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: Advanced Certification in Biopharmaceutical Regulatory Affairs (ACBIODRA)
  • Nature of the course: Online distance learning course. Therefore the course can be accessed online across anywhere 24×7.
  • Duration: 1 Month
  • Course Certificate: Certificate will be provided at the end of the successful completion of the course.

Entire biopharmaceutical regulatory affairs also covers fully in the following courses

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. 

  • 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.
  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
Lecture 49Regulatory Strategies in different phases of Clinical Trial
Lecture 50Advance study on Para IV Filing
Lecture 51Para IV Notices
Lecture 52Evergreening - Patent Life Extension Strategies
Lecture 53REMS Strategic Planning 
Lecture 54Compulsory Licensing
Lecture 55Licensing & Technology Transfer
Lecture 56In-Licensing Vs. Outlicensing
Lecture 57LOE Strategies for Innovator Brands with case study
Lecture 58Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 59Drug Repurposing
Lecture 60Practical Queries on different USFDA application and Filing 
Lecture 61Juxtapid Case Study
Lecture 62New Indication Approval Process and Promotion 
Section 6 Submission Dossier : CTD | ACTD | DMF - SMF-ANDA | 505(b)(2) | NCE | Petittion| Prior Approval Submission
Lecture 63Introduction to Common Technical Document (CTD)
Lecture 64CMC Dossier & Compliance Management
Lecture 65Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 66CMC Dossier & Compliance Management
Lecture 67Introduction to Electronic Common Technical Document (ECTD)
Lecture 68Advance Practical Training on Dossier Preparation focusing on drug registration in export countries 
Lecture 69Importance of effective dossier management
Lecture 70Discussion on 85 common deficiencies in CTD submission dossier
Lecture 71Certificate of Analysis
Lecture 72Detailed Understanding on ANDA Submission Dossier 
Lecture 73Prior Approval Submission 
Section 7Stability Study
Lecture 74Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 75Climatic Zone and Stability Study Conditions as per ICH Guidelines 
Lecture 76Stability Zone Finder
Lecture 77Stability Studies Case Discussions
Lecture 78Case Study: Managing Stability Study for Zone IV countries
Lecture 79Accelerated and intermediate testing conditions
Lecture 80Long Term Stability Testing Requirements
Lecture 81Testing Frequency
Lecture 82Bracketing
Lecture 83Matrixing
Section 8Drug Master File and Site Master File
Lecture 84Key Consideration for Drug Master File Preparation and Submission 
Lecture 85Practical Understanding on Drug Master File Preparation and Submission
Lecture 86Associated Learning: Site Master File - Detailed Understanding 
Lecture 87DMF Completeness Assessment
Lecture 88Drug Master File - Fees
Lecture 89Drug Master File - Global Perspective [Across Different Regions]
Section 9Bioequivalence Study
Lecture 90PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 91Bioequivalence Study | Study design | Different types of BE Studies
Lecture 92Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning  | Analyte | Bioanalytical Methods Validation  | Statistical Model  | Ln Transformation  | Dose normalisation | Confidence interval acceptance criteria
Lecture 93Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission 
Lecture 94Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study 
Lecture 95Bioequivalence Study - Discussion - Dissolution Testing
Lecture 96Bioequivalence Study - Generic Approval and Additives Labeling Requirements 
Section 10Variation Management
Lecture 97Introduction to Variation Management | Reasons for Variation | Working in Variation Department 
Lecture 98Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Section 11Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 99Data Integrity
Lecture 100Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 101Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 102RTQs | Response to Queries | How to handle Regulatory Queries