API Regulatory Affairs

Introduction

Who should attend

Learning Domain

Features

Related Courses

The 1- Month Online Certification Course in API Regulatory Affairs by Royed Training provides a comprehensive understanding of the regulatory landscape governing Active Pharmaceutical Ingredients (APIs). This self-paced online course is designed to equip professionals with the essential knowledge and practical skills required to navigate global API regulations, compliance standards, registration procedures, and quality requirements. The program covers API regulatory strategies, Drug Master File (DMF) and Certificate of Suitability (CEP) submissions, Good Manufacturing Practices (GMP), and regional filing processes across major global markets.

With a practical, case-based approach, the course enables learners to understand real-world regulatory challenges and develop problem-solving skills crucial for the pharmaceutical and biopharmaceutical industries.

Key details about the course:

Course Code: RYD-127
Title: Executive Advanced Certification in API (Active Pharmaceutical Ingredient) Regulatory Affairs (AC-APIRA)
Type of the course: Self paced Online Course. Hence, this course can be accessed online across anywhere 24×7. Moreover, you can attend the course at your convenience in your flexible time. For example, you want to attend the session at your 11 pm at night, you can do that.
Duration of the course: 1 Month. Course can completed within 1 Month based on own speed of access.
Course Certificate: Certificate will be provided at the end of the successful completion of the course.

Who Should Attend:

This course is ideal for:

Regulatory Affairs Professionals working in API registration and compliance
Professionals from API Manufacturing and Export Business
Quality Assurance (QA) and Quality Control (QC) Specialists
R&D Scientists involved in API formulation and development
Business Development and Licensing Teams in API and pharma companies
Consultants and entrepreneurs seeking to understand API regulations
Pharma professionals aspiring to enter API Regulatory Affairs

Learning Domain in API Regulatory Affairs Course

API Regulatory Landscape – Understanding global API regulations in the US, EU, Canada, Japan, China, India, and emerging markets.
API Development and Manufacturing : Key process development techniques, milestones, stages and different manufacturing processes. Course covers in-depth certification requirements for API business.
API Registration & Compliance – Drug Master File (DMF) and Certificate of Suitability (CEP) submission processes.
Regional Regulatory, Business Development, and Market Access : Learn API specific market access requirements in US EU GCC Middle East Africa Japan China India Russia and ROW market.
Good Manufacturing Practices (GMP) Compliance – GMP requirements for API manufacturers and inspections.
Filing Pathways for APIs – US DMF, EU ASMF, CEP, China DMF, Japan DMF, and India’s API regulatory framework.
Regulatory Strategy for API Business Development – API commercialization, licensing, and global market access.
Case Studies & Practical Scenarios – Analyzing real-life API regulatory filings, challenges, and solutions.

Course Features of API Regulatory Affairs

Comprehensive Learning Modules: In-depth exploration of key aspects of Active Pharmaceutical Ingredients (API) business development, including market trends, pricing strategies, regulatory guidelines, and supply chain management.
Industry Insights: Learn from industry experts with real-world case studies, examples, and practical insights into API regulation, filing etc.
Interactive Learning: Engaging multimedia content, quizzes, and assignments to reinforce learning and encourage practical application.
Flexible Access: Learn at your own pace, also with full access to course materials for 1 month
Certification: Gain a globally recognized certification in Pharma API Business Development.

How this course become useful resource for API Regulatory Managers?

Royed Training’s API Regulatory Affairs Course stands out by offering a comprehensive, industry-focused curriculum that integrates global API regulations, compliance strategies, and business development insights. Unlike other courses that focus only on theoretical aspects, this program provides practical case studies, real-world regulatory filing scenarios, and interactive simulations to help professionals navigate API registration, DMF submissions, GMP compliance, and market access. Covering key regulatory frameworks across the US, EU, Canada, Japan, China, India, and emerging markets, the course ensures learners gain a holistic understanding of API regulatory affairs, making it ideal for both technical and business professionals in the pharmaceutical industry.

This self-paced online certification course is designed to equip participants with hands-on knowledge that is immediately applicable in API manufacturing, export business, and regulatory compliance roles. With 24/7 access, expert-developed content, and certification upon completion, learners gain a competitive edge in API regulatory affairs while mastering global regulatory strategies, compliance requirements, and business growth opportunities. Whether you are a regulatory affairs professional, API manufacturer, or business development executive, this course provides the specialized expertise needed to excel in the evolving API regulatory landscape.

Few of the similar courses

Section 1API Market Insight | Manufacturing | Development | Strategic Framework

Lecture 1API Market Insight | Global API Market | Key Drivers and Challenges

Lecture 2Case Insight: Evolution of China and India as dominant API Player

Lecture 3Post Covid-19 API Era: How API industry impacted | Changes observed in post covid-19 era

Lecture 4API Production Trends | API Outsourcing Strategic Planning | Key Strategies and Trends in API Outsourcing

Lecture 5API Industry Key Trend Metrics | Case Based Assessment on Dual Sourcing

Lecture 6API Manufacturing and Development | Understanding critical steps in manufacturing and development of API

Lecture 7Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements

Lecture 8API Registration Pathways | Requirements from Different regions | Focus on API Regulatory Framework | API pathways for US EU Japan and China

Lecture 9General Framework for API Registration | Two case study on API registration and framework

Lecture 10CAS Number | Importance of API Sourcing | Case study

Lecture 11API Sourcing | Checklist Development | How to work step by step in API sourcing?

Lecture 12API BD Tool Training 1 | Case Based Analysis | How to work on the tool

Lecture 13Leading API Sourcing Platforms / Tools

Lecture 14Strategic Alliances in API Business | Types of Alliances | Case studies

Lecture 15Licensing Model in API Industry

Lecture 16Co-development | Co-marketing model in API industry

Lecture 17API Supply Agreement

Lecture 18API Class - Specialty API

Lecture 19API Pricing Strategies

Lecture 20API Market Entry Strategic Planning for EU Market | Strategic Framework

Lecture 21API Market Access LATAM | Brazil

Lecture 22API Monograph

Lecture 23Regionwise API landscape

Lecture 24API pricing strategies

Lecture 25API Global Pricing Strategies

Lecture 26Emerging Market Expansion in API Industry

Lecture 27Certificate of Suitability (CEP) | Significance | Importance | Understanding Regulatory Compliance and Submission Process | Walkthrough

Lecture 28ASMF Filing - Preparation | Documentation and Management | Key Components

Lecture 29Post Approval Management of API

Lecture 30API Global Trade-off Simulation

Lecture 31API Review Test | Check your API Business Competency | Difficulty Level - Easy

Lecture 32CEP Dossier DMF - Differences

Lecture 33Ky differences in API regulatory approval pathways for APIs (Active Pharmaceutical Ingredients) across the US, EU, and emerging markets

Section 2US API R&D Regulation and Strategic Management

Lecture 34R&D Process & Introduction to drug discovery

Lecture 35Investigational New Drug Application (INDA)

Lecture 36New Drug Application (NDA)

Lecture 37Basic concept and understanding of the Generic Drug

Lecture 38Abbreviated New Drug Application (ANDA)

Lecture 40Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements

Lecture 41Purple Book: Significance | Searching | Assignments

Lecture 42Handling of orange book

Lecture 43USFDA expedited programs

Lecture 44Practical Training on INDA, NDA, ANDA filing

Lecture 45505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA

Lecture 46Authorized Generics: Key Understanding

Lecture 47Exploratory IND Vs. Traditional IND

Lecture 48Patents Vs. exclusivity

Lecture 49Orphan Drug Designation

Lecture 50Advance Learning on 505B2 Pathway

Lecture 51Chemistry, Manufacturing & Controls

Lecture 54Clinical Trial Protocol Writing

Lecture 55Ethics in Clinical Research

Lecture 56Informed Consent | Practical Training on preparing ICF | Ready Templates

Lecture 57FDA Forms and How to fill the resources

Lecture 58Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !

Lecture 59Importance and Significance of Phase 2b Clinical Trial

Lecture 60Regulatory Strategies in different phases of Clinical Trial

Lecture 61Para IV Filing - Strategic Insight

Lecture 62Para IV Notices

Lecture 63Evergreening - Patent Life Extension Strategies

Lecture 64Pay For Delay Strategy

Lecture 65REMS Strategic Planning

Lecture 66Compulsory Licensing

Lecture 67Licensing & Technology Transfer

Lecture 68In-Licensing Vs. Outlicensing

Lecture 69LOE Strategies for Innovator Brands with case study

Lecture 70Pediatric Exclusivity and Pediatric Study Plan Development

Lecture 71Drug Repurposing

Lecture 72Advance understanding of the portfolio Management

Lecture 73New Indication Approval Process and Promotion

Lecture 74OTC Switch

Lecture 75Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning

Lecture 76NCE Vs. 505b2 application - Case Based Learning

Lecture 77FTF - 180 Days Exclusivity - Case Based Learning

Lecture 78Classic case study of the 505b2 filing : Case Based Learning

Lecture 79Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning

Lecture 80Pipeline in a molecule | Case Study

Lecture 81USFDA Emergency Use Authorization (EUA)

Lecture 82Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)

Lecture 83Fundamental 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 84Review on Drug Discovery and Development

Section 3EU API Business and Strategic Management

Lecture 85Introduction to EU Regulation

Lecture 86Orientation to European Countries and National Regulatory Bodies

Lecture 87EU Drug Discovery Development to Commercialization (Step By Step)

Lecture 88Overview of EU Regulation

Lecture 89EMA and EMA Authorisation Process

Lecture 90EU MA Application Types and Strategic Planning

Lecture 91EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure

Lecture 92EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application

Lecture 93Validity of the EU MA - Renewal steps, Cessation of the marketing authorisation, Significance of "Placed in Union Market", Suspension or withdrawal & EU MA for licensed products

Lecture 94Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae

Lecture 95EU Orphan Medicinal Products Regulation

Lecture 96Conditional marketing authorisation | Marketing authorisation under exceptional circumstances

Lecture 97Summary of Product Characteristics

Lecture 98Compassionate Use

Lecture 99MHRA - UK Regulation

Lecture 100The 'sunset clause' for marketing authorisation of pharmaceuticals

Lecture 101Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP) - EU Requirments

Lecture 102EU Prime Designation

Lecture 103Accelerated assessment by EMEA

Lecture 104EU Adaptive Pathway

Lecture 105European public assessment report (EPAR) - Importance, Component, Management, Updation

Lecture 106SPOR - Concept of Master Data Management

Lecture 107Policy 0070 | RPDP Submission and Management timeline | Anonymisation Report (AnR) - Significance | AnR in FRDP

Section 4API Plant Management and Certification | Quality Management

Lecture 108Premises & Plant Layout Designing

Lecture 109Sanitation and Hygiene

Lecture 110Equipment Modules

Lecture 111Production Modules

Lecture 112Documentation

Lecture 113Quality Control

Lecture 114Product Complaint

Lecture 115Storage Module

Lecture 116Pharmaceutical SOPs Management from regulatory perspective

Lecture 117Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter

Lecture 118Data Integrity issues in Pharmaceutical Industry

Lecture 119Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity

Lecture 120Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management

Section 5API Documentation - Submission Management

Lecture 121Introduction to Common Technical Document (CTD)

Lecture 122CMC Dossier & Compliance Management

Lecture 123Introduction to Electronic Common Technical Document (ECTD)

Lecture 124Advance Practical Training on Dossier Preparation focusing on drug registration in export countries

Lecture 125Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study

Lecture 126Key Consideration for Drug Master File Preparation and Submission

Lecture 127Practical Understanding on Drug Master File Preparation and Submission

Lecture 128Associated Learning: Site Master File - Detailed Understanding

Lecture 129DMF Completeness Assessment

Lecture 130Drug Master File - Fees

Lecture 131Drug Master File - Global Perspective [Across Different Regions]

Lecture 132Importance of effective dossier management

Lecture 133Discussion on 85 common deficiencies in CTD submission dossier

Lecture 134Certificate of Analysis

Lecture 135Detailed Understanding on ANDA Submission Dossier

Section 6Japan API Registration and Strategic Management

Lecture 136Introduction to Japan Drug Regulatory Affairs

Lecture 137Drug Discovery Development to commercialization | PMDA functions | Consultation | Premarket to post market approval

Lecture 138Drug Approval System | GCP | PMDA requirements

Lecture 139New Drug Application | Requirements | Review Process

Lecture 140Generic Drug Application Review and Approval

Lecture 141Marketing Authorization Process for registration of pharmaceutical in Japan

Lecture 142API Registration in Japan | Step By Step Process

Lecture 144Priority Review Application | Criteria | Review Process | Timeline

Lecture 145Orphan Drug Designation in Japan

Lecture 146Japan DMF System | MF filing Process | Key points

Lecture 147Strategic Approval Pathway - Formulation Approval Quoting MF

Lecture 148SAKIGAKE designation

Section 7API Business : Latam

Lecture 149Introduction to Latam Region Pharma Business Development

Lecture 150Drug Registration and Regulation in Argentina

Lecture 151Drug Registration and Regulation in Bolivia

Lecture 152Drug Registration and Regulation in Brazil

Lecture 153Drug Registration and Regulation in Chile

Lecture 154Drug Registration and Regulation in Colombia

Lecture 155Drug Registration and Regulation in Mexico

Lecture 156Drug regulation and registration in Peru

Lecture 157Drug regulation and registration in El Salvador

Lecture 158Central America Drug Regulatory Affairs | Panama, Costa Rica, Guatemala, El Salvador, Honduras, Dominican Republic | RTCA guideline [2022]

Section 8API Business : Africa

Lecture 159African Continent Overview - Brief introduction

Lecture 160African Pharma Market

Lecture 161Drug Registration - African medicines regulatory

Lecture 162Basic Export Requirement for African Countries

Lecture 163Export Documentations & Important Concepts

Lecture 164Nigeria - Drug Registration

Lecture 165Drug Registration in Algeria

Lecture 166Drug Registration in Ethiopia

Lecture 167Drug Registration in Kenya

Lecture 168Drug Registration in Egypt

Lecture 169Drug Registration in Ghana

Lecture 170Drug Registration in Botswana

Lecture 171Drug Registration in South Africa

Lecture 172Drug Registration in Zambia

Lecture 173Drug Registration in Namibia

Lecture 174Drug Registration in Tanzania

Lecture 175Drug Registration Senegal

Lecture 176Drug Registration in Zimbabwe

Lecture 177Drug Registration in Uganda

Lecture 178Drug Registration in Morocco

Lecture 179Drug Registration in Sudan

Section 9API Business : GCC, Middle East and MENA

Lecture 180Middle East / MENA / GCC Countries Geographical Orientation

Lecture 181Middle East / MENA / GCC Countries National Regulatory Agencies

Lecture 182GCC Registration Procedure - Centralized and Decentralized Procedure | Detailed understanding on Centralized Registration Process

Lecture 183Drug Registration in Saudi Arabia

Lecture 184Drug Registration in UAE

Lecture 185Drug Registration and Regulatory Strategic Planning for Iran

Lecture 186Drug Registration and Regulatory Strategic Planning for Israel

Lecture 187Middle East Pharma Market

Lecture 188Drug Registration in Jordan

Lecture 189Drug Registration in Palestine

Section 10API Business : ASEAN

Lecture 190ASEAN - Region - Introduction

Lecture 191ASEAN Countries | Introduction | Geographical Overview

Lecture 192ASEAN countries drug regulatory bodies

Lecture 193ASEAN Common Technical Requirements (ACTRs)

Lecture 194The Pharmaceutical Inspection Co-operation Scheme

Lecture 195CPP Requirements for Drug Registration in ASEAN countries

Lecture 196Dossier Requirements - ACTD/CTD Acceptability

Lecture 197Pharmacopoeias Acceptability

Lecture 198Harmonization of Technical Guidelines

Lecture 199Stability Study requirements for drug registration in ASEAN countries

Lecture 200Product Labelling

Lecture 201Post Approval Changes (Variations) requirements in ASEAN countries

Lecture 202Pharmacovigilance and Risk Management Plan (RMP)

Lecture 203Timeline of Drug Registration Approval

Lecture 205Drug Registration and Regulation Singapore | Strategic Pathways for Marketing Authorization | Screening, Evaluation of MA applications | Variations Classifications and Management

Lecture 206Drug Registration and Regulation in Brunei

Lecture 207Drug Registration and Regulation in Cambodia

Section 11API Business - CIS - EAEU | Russia

Lecture 208Drug Registration and Submission Strategic Planning for Russia and EAEU region

Lecture 209GMP requirements in Russia

Section 12API Business : China

Lecture 210Drug Registration and Regulation in China

Lecture 211NMPA's DDR and DMR update

Section 13API Business - India

Lecture 213Medicine Export Criteria from India

Lecture 214Documents for conducting BE Study for Export

Lecture 215New Drug Approval in DCGI

Lecture 216Line Extension New Strength Approval

Section 14API Business - CIS - EAEU | Russia

Lecture 217Drug Registration and Submission Strategic Planning for Russia and EAEU region

Lecture 218GMP requirements in Russia

Section 15Bioequivalence Study : Requirements

Lecture 219PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process

Lecture 220Bioequivalence Study | Study design | Different types of BE Studies

Lecture 222Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission

Lecture 223Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study

Lecture 224Bioequivalence Study - Discussion - Dissolution Testing

Lecture 225Bioequivalence Study - Generic Approval and Additives Labeling Requirements

Lecture 226IVIVC - Basis | Importance | Case Based Determination of IVIVC

Lecture 227Setting Dissolution Specification for Generic Products | Regulatory Expectations

Section 16Variation Filing : Marketing Authorization variation management

Lecture 228Introduction to Variation Management | Reasons for Variation | Working in Variation Department

Lecture 229Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.

Section 17Biologic API | Understanding Class | Specific Registration Requirements | Strategic Planning

Lecture 230Introduction : Biopharmaceuticals

Lecture 231Classification of Biopharmaceutical

Lecture 232Important Concept regarding Biopharmaceuticals

Lecture 233Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product

Lecture 234Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs

Lecture 235Principle of Naming of Biologic | Understanding on MAB naming system

Lecture 236Global Biopahrma Market Trends

Lecture 237Recombinant protein

Lecture 238Monoclonal Antibodies Vs. Polyclonal Antibodies

Lecture 239Monoclonal Antibodies

Lecture 240Synthetic Immunomodulators

Lecture 241Production of Monoclonal Antibodies

Lecture 242Cytokines

Lecture 243Interferon

Lecture 244Erythropoiesis-stimulating agent

Lecture 245Vaccine development and approval Process

Lecture 246Biosimilar Development Process

Lecture 247Strategic Consideration for Biosimilar Development

Lecture 248Bio-Manufacturing Process Information

Lecture 249Studies required for approval of biosimilar

Lecture 250ATMPs | Types and Classification | Regulatory Mechanism

API Regulatory Affairs

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Introduction

Who should attend

Learning Domain

Features

Related Courses

Key details about the course:

Who Should Attend:

Learning Domain in API Regulatory Affairs Course

Course Features of API Regulatory Affairs

How this course become useful resource for API Regulatory Managers?

Few of the similar courses

API Regulatory Affairs

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Introduction

Who should attend

Learning Domain

Features

Related Courses

Key details about the course:

Who Should Attend:

Learning Domain in API Regulatory Affairs Course

Course Features of API Regulatory Affairs

How this course become useful resource for API Regulatory Managers?

Few of the similar courses