InstructorRoyed Training
TypeOnline Course
Student Enrolled5
Price$690 USD / 34500 INR.
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biologic regulatory affairs course



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Biologic Regulatory Affairs pg certification course

Biologic regulatory affairs course provides comprehensive training on innovator biologic and biosimilar regulation and registration process. Major focus is on learning how innovator biologics and biosimilar R&D, process development, manufacturing takes place. Further, it covers regulation and registration strategic management process. Hence, this is a 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 get the real life understanding in the steps of the biologic (biotech and biosimilar) R&D, process development and manufacturing, commercialization process related strategic planning.

Snapshot of the course

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-110
  • Course Title: PG Certification in Biologic Regulatory Affairs (PGBRA)
  • Nature of the course: Online distance learning course. Therefore the course can be accessed online across anywhere 24×7.
  • Duration: 1 Year
  • 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 Biologic Regulatory Affairs online course utilizes interactive e-learning tools. Hence, this provides seamless practical learning experience.

This online biologic 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 biologic manufacturing and marketing 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.

Who should attend the course?

  • Those who want to know about the Biologic 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 biologic 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.
  • This course is ideal for those who want to learn biosimilar regulatory affairs.
  • Biologic regulatory affairs course will be fundamental for Biologic Business Development and Strategic Management professionals.
  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 Regulatory Affairs department in a biologic company

A career in biologic regulatory affairs involves working in a field that focuses on ensuring compliance with regulations and guidelines related to the development, approval, and post-marketing activities of biologic products. Biologic products include vaccines, gene therapies, blood products, and other treatments derived from living organisms.

Role and Key Responsibilities of the Biologic Regulatory Affairs professional

Regulatory Compliance

Regulatory affairs professionals in the biologic industry are responsible for understanding and interpreting regulations and guidelines set forth by regulatory authorities. They ensure that biologic products and their associated documentation meet all necessary requirements.

Product Registration and Approval

Regulatory affairs professionals play a crucial role in the submission and approval process for biologic products. They prepare and submit regulatory applications, including investigational new drug (IND) applications, biologics license applications (BLAs), and marketing authorization applications (MAAs). They work closely with cross-functional teams, including researchers, clinicians, and manufacturing experts, to gather and compile the necessary data and documentation for submissions.

Regulatory Strategy

There is no doubt of the fact that Developing a regulatory strategy is an important aspect of regulatory affairs. Certainly, professionals in this field provide strategic guidance to ensure that product development plans align with regulatory requirements. For instance, they assess the regulatory landscape, anticipate potential challenges first. Further they will develop strategies to address them. Hence, this involves staying up to date with the latest regulatory developments and industry trends.

Labeling and Advertising

Regulatory affairs professionals ensure that product labeling and advertising materials comply with regulatory guidelines. For instance, they are responsible for review and approve labeling content, including package inserts, patient information leaflets, and promotional materials. Therefore this will ensure accuracy and compliance of the biologics.

Post-Marketing Compliance

Once a biologic product is approved and on the market, regulatory affairs professionals monitor post-marketing activities to ensure ongoing compliance with regulatory requirements. In fact they manage post-approval submissions, track adverse events. In addition, they ensure timely reporting to regulatory authorities. They also stay updated on changes to regulations and guidelines that may impact post-marketing activities.

Liaison with Regulatory Authorities

Above all, regulatory affairs professionals serve as a point of contact between the biologic company and regulatory authorities. They may participate in meetings with regulatory agencies, address queries or requests for additional information, and represent the company’s interests during regulatory inspections or audits.

Qualification and skill required for Biologic Regulatory Affairs Professionals

  • To pursue a career in biologic regulatory affairs, a background in life sciences, pharmacy, or a related field is typically required.
  • Many regulatory affairs professionals also hold advanced degrees, such as a Master’s or even higher.
  • Above all, strong attention to detail, knowledge of regulatory guidelines, excellent communication skills, and the ability to work in cross-functional teams are important qualities for success in this field.
  • In fact, PG Certification Biologic regulatory affairs (PGBRA) course will enhance your acceptance of your candidature as the course provides hands on training on Biologic and Biosimilar regulation, registration and strategic planning process.

Periodic update is the key for Biologic Regulatory professionals

  • Above all, biologic regulations and requirements can vary between countries and regions. Therefore, familiarity with the specific regulatory environment of the target market is essential. Additionally, staying up to date with evolving regulations and guidelines is crucial to effectively navigate the dynamic regulatory landscape in the biologic industry. In this regard, PG Certification Biologic regulatory affairs (PGBRA) plays a forehand role to keep user informed about the changing guideline of biologic industry.

Some 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.
  • Advanced Therapy Medicinal Products (ATMPs).
  • 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.
  • Biosimilar Approval Pathways
  • Key important issues in Biotech and biosimilar product manufacturing. Insight on biosimilar approval pathway.

Biologic CMC writing and management 

  • Biologics Product Characteristics and Regulatory Implications
  • Quality By Design
  • QbD and TPP
  • Comparability of biologic products
  • CMC strategic planning for various types of the biologics
  • Documentation requirements

Biologic Manufacturing 

  • GMP requirements for Biologic Products.
  • Biologic and Biosimilar manufacturing process.
  • Plant audits, warning letters, CRL.

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 biologic strategic management.

Country specific guidelines

  • Biologic regulations in US, EU, LATAM, Middle East / GCC, LATAM, Japan, ASEAN, India and ROW market.
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 5Biopharmaceutical Market Segmentation - Global Biologics Market – By Product
Section 2Biopahrmaceutical Classification and study on each class
Lecture 6Recombinant protein
Lecture 7Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 8Monoclonal Antibodies : Detailed Understanding
Lecture 9Synthetic Immunomodulator
Lecture 10Production of Monoclonal Antibodies
Lecture 11Cytokines
Lecture 12Interferon
Lecture 13Erythropoiesis-stimulating agent
Lecture 14ATMPs | Types and Classification | Regulatory Mechanism 
Lecture 15mAB - At a glance
Lecture 16ATMPs - at a glance
Lecture 17CAR-T Therapy | Different Types of CAR-T Therapy | Mechanism of action | Challenges | Brainstorming on Concept of Personalized Medicine | Understanding on marketed formulation
Lecture 18Live Biotherapeutic Products | LBPs | Class | Mechanism | Indication Positioning | Regulatory Requirements for LBPs 
Section 3Biopahramaceutical Regulatory Pathways
Lecture 19R&D Process & Introduction to discovery, development to commercialization process
Lecture 20Investigational New Drug Application (INDA)
Lecture 21New Drug Application (NDA) 
Lecture 22 Biological Licensing Application (BLA) 
Lecture 23Basic concept and understanding of the Generic Drug
Lecture 24Abbreviated New Drug Application (ANDA) 
Lecture 25Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 26505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 27Purple Book: Significance | Searching | Assignments
Lecture 28Nomenclature of biosimilars
Lecture 29Vaccine development and approval Process
Lecture 30REMS Strategic Planning 
Lecture 31PDUFA For Biologics
Lecture 32Clinical Trials Terminologies 
Lecture 33Advance Learning on 505B2 Pathway
Lecture 34FDA Forms and How to fill the resources
Lecture 35Chemistry, Manufacturing & Controls 
Lecture 36Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 37Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) 
Lecture 38USFDA expedited programs for Pharmaceuticals and Biopharmaceuticals
Section 4Bio-manufacturing | Biosimilar Development | CMC requirements
Lecture 39Biosimilar Development Process
Lecture 40Strategic Consideration for Biosimilar Development 
Lecture 41Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 42Bio-Manufacturing Process Information
Lecture 43Concept of Interchangeability in Biosimilar Development
Lecture 44Studies required for approval of biosimilar
Lecture 45Demonstrating Biosimilarity: A More Complex Task 
Lecture 46Fermentor | Bioreactor
Lecture 47Comparability of Biologics | Different Categories of Comparability | General Principles 
Lecture 48CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)
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  
Section 12Evidence Generation | Real World Data | Real World Evidence
Lecture 103Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence? 
Lecture 104RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making
Lecture 105RWD and RWE in Product Lifecycle Management
Lecture 106RWD and RWE - Fit to use | Assessment 
Lecture 107RWD data sources | Different types | Detailed understanding of each class