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Drug Regulatory Affairs and Pharmacovigilance training




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Advanced Diploma in Drug Regulatory Affairs and Pharmacovigilance course provides practical hands on knowledge in both the domain regulatory and pharmacovigilance under single course. Hence, participants who want to undergo pharmacovigilance and drug regulatory affairs can opt for this course, instead of undergoing two different course.

This unique self paced training covers in-depth Drug Regulatory Affairs with advanced regional Drug Regulatory Affairs and drug safety management. Therefore, one can get the entire knowledge of regulation, registration, drug safety management under single dynamic course. 

  • Code: KPE-C-043
  • Course Title: Advanced Diploma in Drug Regulatory Affairs and Pharmacovigilance [ADRAPV]
  • Nature of the Course: Distance & e-Learning

The course comprehensively covers complete syllabus of Drug Regulatory Affairs and Pharmacovigilance individually. 

1 Year.

B.Pharma/D.Pharma/ B.Sc/ Any graduates or Post Graduates or Phd holder, who want to broaden the career skill in drug regulatory affairs can pursue the course. 3rd and final year student also can pursue this program.

Advanced Diploma in Drug Regulatory Affairs and Pharmacovigilance course provides comprehensive training on drug regulatory affairs and pharmacovigilance under the single course. 

In the area of regulatory affairs, course covers general Drug Regulatory Affairs with practical real life simulation. Therefore, one can get the entire knowledge of Regulatory Affairs. 

Drug Regulatory Affairs Topics 

  • Fundamental to Drug Discovery Development to Commercialization
  • Clinical Research – Advance Learning
  • IPR strategic planning – Patent, Trademarking. Patent and trademark filing, registration, objection, opposition handling process. Patent Term Extension, Patent Term Restoration.
  • Marketing Authorization Process and strategic pathways for pharmaceuticals, Biopharmaceutical products. 
  • Generic Drug and Innovator Molecule’s Marketing Authorization Process
  • ANDA preparation and filing  – ANDA submission, Para IV filing, first to file. 
  • Portfolio Management – case based learning – Training on Loss of Exclusivity Management, Evergreening tools and techniques. Various strategic planning. 
  • GMP – GMP training, GMP Audits, 483 observations, warning letter, data integrity, SOP Management, CAPA
  • Stability study – Requirements, types of stability study, management of stability studies and requirements.
  • Variation Management – Authorization management, regional differences. 
  • DMF preparation and filing, SMF preparation and filing
  • Drug Dossier Preparation, filing and management of the dossier for different product classes. 
  • Advance training on biopharmaceutical – innovator and biosimilar regulatory pathway. 

Pharmacovigilance Topics 

The course has been designed and tailored specifically to the needs of pharmacovigilance learning from practical point of view.

The Overview of Pharmacovigilance & Drug Safety course gives you a good understanding of the basic to advanced principles of pharmacovigilance – the course covers the history of pharmacovigilance & drug safety, key components within adverse event reporting in the clinical and post-marketing settings and an overview of signal detection & risk management.

Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence and regulatory compliance. This module will provide you with a strong foundation of knowledge on pharmacovigilance and drug safety.

  • Introduction to Clinical Research and Pharmacovigilance
  • Global Pharmacovigilance System
  • Sources and Documentation of Individual Case Safety Reports (ICSRs)
  • Case processing and Reporting
  • Medical dictionary (MedDRA) and Medical aspects in Pharmacovigilance
  • Special cases in Pharmacovigilance
  • Medical Information System
  • Safety monitoring in Clinical Trials
  • Signal detection
  • Periodic Safety Update Reports (PSURs)
  • Risk –benefit assessment and management in Pharmacovigilance
  • Standard operating procedures in Pharmacovigilance
  • Compliance monitoring and Pharmacovigilance inspections
  • Global regulatory requirements and guidelines in Pharmacovigilance
  • Pharmacovigilance communications
  • Pharmacoepidemiology

Here the key features of the course.

  • Access the courses 24×7 at your convenience
  • Online interactive sessions with the expert Industry faculty
  • e-Library and e-pharma dictionary
  • Access to 1000’s of real life case studies
  • Online assignments & self Assessment Test
  • Printed Course Material
  • 24/7 Online Support With the Live Chat Facility
  • Special On demand Modules
  • Secure access to e-module with passwords.
  • Flexible online final examination (Computer Based Test by secure mode)
  • Our courses can be accessed anytime from anywhere

Benefits of the course

  • Certification – Receive a personal certificate to show your subject knowledge on course completion. Most importantly, Course completion and gradation certificate is provided on the completion of the course.
  • Affordable – Here in this course, you will be learning regulatory affairs and pharmacovigilance both under single course. Hence, you will get excellent value through our cost-effective prices than purchasing both the course separately.
  • Flexibility – This is self paced learning. Hence, you can attend the course at own convenience. This lets you complete the interactive course at your own comfort. Therefore, it saves saves you time through the convenience of online availability.
  • Keep Up to Date – You will stay up to date with any legislative changes in regulatory affairs and pharmacovigilance as our training courses are constantly monitored, reviewed and updated periodically. Even the latest regulatory changes are incorporated in the course.
  • Learn from Industry Experts – The course content has been developed to ensure that you comply with regulatory and pharmacovigilance legislation through the application of learning outcomes.

Section 1Fundamental of Drug Discovery, Development (US Regulation)
Lecture 1Introduction to R&D Process
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA)
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Review on Drug Discovery and Development
Lecture 7Generic Drug User Fees Act (GDUFA)
Lecture 8Prescription Drug User Fees Act (PDUFA)
Lecture 9Handling of orange book
Lecture 10USFDA expedited programs
Lecture 11Practical Training on INDA, NDA, ANDA filing
Lecture 12505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 13Authorized Generics: Key Understanding
Lecture 14Exploratory IND Vs. Traditional IND
Lecture 15Patents Vs. exclusivity
Lecture 16Learning from New Drug Approvals
Lecture 17Orphan Drug & Orphan Drug Act
Lecture 18Advance Learning on 505B2 Pathway
Section 2Clinical Trial
Lecture 19Clinical Trials Terminologies
Lecture 20Clinical Trial Protocol Writing
Lecture 21Ethics in Clinical Research
Lecture 22Informed Consent
Lecture 23FDA Forms and How to fill the resources
Lecture 24Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 3IPR related topics
Lecture 25Introduction to intellectual Property Management
Lecture 26Introduction to Patent 
Lecture 27Understanding on Patent System
Lecture 28Patent Grant and Managing Patent Filing Procedure
Lecture 29Steps Know How & Key Points - Patent Application
Lecture 30Scope of Patentability 
Lecture 31Patent Grant and Handling Process in India 
Lecture 32Stages of Patent Grant Procedure
Lecture 33Patent search in Indian Patent Office
Lecture 34Differences in US and European Patent
Lecture 35Patent Claim | Types of Patent Claims 
Lecture 36Patent Cliff | How to calculate the patent cliff
Lecture 37Terminologies related to patent, trademark, copyright and licensing 
Lecture 38Patent Infringement
Lecture 39Introduction to Trademark | Trademark filing procedure
Lecture 40Trademark Searching Process | EUIPO Searching | USPTO Searching | IPINDIA Searching 
Lecture 41Trademark Infringement | Passing off | Practical Cases
Lecture 42Trademark Classes | How to search the right trademark class for for filing trademark application
Section 4Regulatory Strategies in different phases of Clinical Trial
Lecture 43Regulatory Strategies in different phases of Clinical Trial
Lecture 44Advance study on Para IV Filing
Lecture 45Para IV Notices
Lecture 46Evergreening - Patent Life Extension Strategies
Lecture 47Pay For Delay Strategy
Lecture 48REMS Strategic Planning 
Lecture 49Compulsory Licensing
Lecture 50Licensing & Technology Licensing
Lecture 51In-Licensing Vs. Outlicensing
Lecture 52LOE Strategies for Innovator Brands with case study
Lecture 53Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 54Drug Repurposing
Section 5Good Manufacturing Practices
Lecture 55Definition of GMP
Lecture 56Certification Pharmaceutical Companies / Plants
Lecture 57Introduction to Good Manufacturing Practices
Lecture 58G1 Lecture Premises & Plant Layout Designing
Lecture 59G2 Lecture Sanitation and Hygiene
Lecture 60G3 Lecture Equipment Modules
Lecture 61G4 Lecture Production Modules
Lecture 62G5 Lecture Documentation
Lecture 63G6 Lecture Quality Control
Lecture 64G7 Lecture Product Complaint
Lecture 65G8 Lecture Storage Module
Lecture 66ISO and ISO Audits
Lecture 67Pharmaceutical SOPs Management from regulatory perspective
Lecture 68SOP Automation in Pharmaceutical Industry
Section 6DMF & SMF
Lecture 69Key Consideration for Drug Master File Preparation and Submission 
Lecture 70Practical Understanding on Drug Master File Preparation and Submission
Lecture 71Site Master File - Detailed Understanding 
Lecture 72DMF Completeness Assessment
Lecture 73Drug Master File - Fees
Lecture 74Drug Master File - Global Perspective [Across Different Regions]
Section 7Biosimilar
Lecture 75Introduction to Biosimilar
Lecture 76Biosimilar Approval process
Lecture 77Biological Licensing Application (BLA)
Lecture 78Vaccine development and approval Process
Section 8USFDA Warning Letter & CAPA
Lecture 79USFDA Warning Letter & CAPA
Lecture 80USFDA Warning Letter
Lecture 81Handling of warning letter
Lecture 82Case Study: Warning Letter for The Halol plant of Sun Pharma
Section 9Drug Registration in European Country (Optional)
Lecture 83Introduction to EU Regulation
Lecture 84Orientation to European Countries and National Regulatory Bodies
Lecture 85Overview of EU Regulation
Lecture 86EMEA Procedures
Lecture 87Summary of Product Characteristics
Lecture 88Compassionate Use
Lecture 89Orientation to European Countries and National Regulatory Bodies
Lecture 90MHRA - UK Regulation
Lecture 91EU Orphan Medicinal Products Regulation
Section 10Drug Regulation in GCC countries (Optional)
Lecture 92Regions in Pharma Business : Common Terminologies
Lecture 93GCC Pharma Market
Lecture 94GCC Export – Local Partner
Lecture 95GCC Registration Procedure
Lecture 96Drug Registration in Saudi Arabia
Lecture 97Documentation Required for the GCC countries
Lecture 98Drug Registration in Beherain, UAE, Kuwait, Qatar, Oman
Lecture 99Medical Device Regulation in GCC countries
Section 11Drug Dossier Preparation
Lecture 100Introduction to Common Technical Document (CTD)
Lecture 101Asean Common Technical Document (ACTD)
Lecture 102Electronic Common Technical Document (ECTD)
Lecture 103Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 104Modules on Stability Study 1
Lecture 105Stability Study Test
Lecture 106Module on Interchangeability
Lecture 107Stability Testing of API
Lecture 108Stability Testing of Finished Pharmaceutical Products
Lecture 109Review Test on Stability Testing
Section 12Project Management skills for regulatory professionals (Optional)
Lecture 110Portfolio Management
Lecture 111Importance of market research in pharmaceutical industry
Lecture 112Co-promotion & Co-marketing strategy in pharma industry
Lecture 113Concept of Reverse co-promotion in pharma industry
Lecture 114In-Licensing Vs. Outlicensing
Lecture 115Publication Management from Regulatory perspective
Lecture 116Juxtapid Case Study
Lecture 117New Indication Approval Process and Promotion
Lecture 118OTC Switch
Lecture 119Rx-to-OTC switch
Section 13API Regulatory Affairs
Section 14Drug Registration in ASEAN countries (Optional)
Lecture 121ASEAN Drug Regulatory Affairs
Lecture 122Asean Geography
Lecture 123Drug Registration in Brunei
Lecture 124Drug Registration in Malaysia
Lecture 125Drug Registration in Cambodia
Lecture 126Drug Registration in Mayanmar
Lecture 127Drug Registration in Philippines
Lecture 128Drug Registration in Singapore
Section 15Pharmacovigilance : Welcome Session
Section 16Introduction: Pharmacovigilance
Section 17Adverse Effect : Introduction
Section 18ADR Pharmacology
Section 19Controversies on ADR
Section 20Classification of adverse reactions
Section 21Why pharmacovgilance process?
Section 22Adverse Effect
Section 23PSURs
Section 24Risk Management
Section 25Pharmacovigilance regulatory authorities
Section 26International collaboration on pharmacovigilance
Section 27Regulatory body adopting pharmacovigilance program
Section 28Pharmacovigilance Framework
Section 29The Summary of Product Characteristics (SmPC, SPC)
Section 30Pharmacovigilance Software
Section 31Pharmacovigilance in India
Section 32Good Pharmacovigilance Process (GPVP)
Section 33Case Study: How ADR is monitored in Malyasia?
Section 34Role of Drug Safety Associates
Section 35Naranjo Algorithm - ADR Probability Scale