TypeOnline Course
(5 ratings)
Price$790 / Rs. 38500
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Admission Process

Admission Process

Upon receiving your filled up application form, our admin team will generate PROVISIONAL ADMISSION ID and send you the PROVISIONAL ADMISSION LETTER along with instruction to course fees payment options.

Course Application Form

Course Eligibility: B.Pharm/D.Pharm/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in pharmaceutical regulatory affairs and pharmacovigilance.

Features of the Course:

1. Comprehensive study material covering all important aspects of pharmaceutical regulatory affairs and pharmacovigilance

2. Understanding/ Decision Making/ Strategy Creation in the field of pharmaceutical regulatory affairs and pharmacovigilance

3. Pharma Marketing & Regulatory Affairs Case Study (Online Databank) File for effective skill enhancement for strategic decision making

4. Support : Resume Development, Placement Assistance.

Course Duration: 1 Year

Nature of the Course: Distance & e-Learning

Learning Mode:

  • 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

Syllabus: Complete syllabus of Drug Regulatory Affairs and Pharmacovigilance will be covered. 

The Overview of Pharmacovigilance & Drug Safety course gives you a good understanding of the basic 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.

Content

The course has been designed and tailored specifically to the needs of research industry.

• 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

Careers in Pharmacovigilance:

Pharmacovigilance are extremely important functions throughout the development, marketing and continued use of any medication. People in these roles are responsible for monitoring, controlling, processing and reporting the adverse event data obtained from various clinical trials and post-marketing safety. A career in Pharmacovigilance starts with a position as a drug safety associate, officer, scientist or coordinator. Responsibilities then progress to senior specialist or management roles, often with an in-depth knowledge of a specialty area.

Career Growth

• DSA (Drug Safety Associate)

• DSS (Drug Safety Scientist)

• Aggregate report scientist

• Team lead or Team manager

• Director or Vice-President

Growth prospect:

Individuals trained in Pharmacovigilance will find good job options in the following sectors:

• Pharmaceutical Companies (MNCs & Indian) & Biotech companies.

• Clinical Research Organizations

• KPOs like Accenture & Quintiles.

• Regulatory Agencies like CDSCO

• Pharmacovigilance units in Medical colleges & Hospitals

Besides this, students might land up in companies like:

Asian clinical trials serene, Bioserve, Clin invent, Clintec international, Clinigene, Dr Reddy’s lab, Elly Lilly, Glaxo smithkline, IGATE clinical research, Intass biopharmaceuticals, Johnson & Johnson, Lambda therapeutic research, Lupin limited, Matrix laboratories ltd., Merck, Novartis, Novo Nordisk, Pfizer, Pharmanet, Quintiles, Ranbaxy, Roche India, Sristek, Siro Clinpharma, Synchron, Sanofi Aventis, Torrent pharma, Vimta labs, Zydus, Reliance life science, Amed, Accutest, Actimus, Adroit insights, Alembic, Paraxel, Mahindra Satyambsg, Aurobindo, Sristek, Shantha Biotechnics, Nektar Therapeutics, Vimta Labs, Biological E. Ltd, Synowledge Pv Services, Biocon, Accenture, Astrazeneca, Bluefish, Sciformix/Strides Acrolabs, Norwich Clinical Services, Hcl, Omnicare, Clinical Research, Micro Labs, Ecron Acunova, G7 Infotech, Cognizant, Tcs and many more companies

Benefits to you:

• Certification – Receive a personal certificate to show your subject knowledge on course completion.

• Affordable – You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.

• Flexibility – The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.

• Keep Up to Date – You will stay up to date with any legislative changes in pharmacovigilance as our training courses are constantly monitored, reviewed and updated.

• Learn from Industry Experts – The course content has been developed to ensure that you comply with 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 25IPR - Introduction
Lecture 26Patent
Lecture 27Patent - Practical on search and filing
Lecture 28Trademark Search and Registration in US
Lecture 29Steps Know How & Key Points - Patent Application
Lecture 30IPR - Patent Grant and Handling Process in India (Optional)
Lecture 31Patent - Practical on search and filing in Indian Patent Office (Optional)
Lecture 32Trademark - Practical on TM Search & Registration Process in India (Optional)
Lecture 33Trademark Search assignment (India) - (Optional)
Lecture 34Fundamental Understanding of Patent, Trademark Licensing and related terminology
Section 4Regulatory Strategies in different phases of Clinical Trial
Lecture 35Regulatory Strategies in different phases of Clinical Trial
Lecture 36Advance study on Para IV Filing
Lecture 37Para IV Notices
Lecture 38Evergreening - Patent Life Extension Strategies
Lecture 39Pay For Delay Strategy
Lecture 40REMS Strategic Planning 
Lecture 41Compulsory Licensing
Lecture 42Licensing & Technology Licensing
Lecture 43In-Licensing Vs. Outlicensing
Lecture 44LOE Strategies for Innovator Brands with case study
Lecture 45Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 46Drug Repurposing
Section 5Good Manufacturing Practices
Lecture 47Definition of GMP
Lecture 48Certification Pharmaceutical Companies / Plants
Lecture 49Introduction to Good Manufacturing Practices
Lecture 50G1 Lecture Premises & Plant Layout Designing
Lecture 51G2 Lecture Sanitation and Hygiene
Lecture 52G3 Lecture Equipment Modules
Lecture 53G4 Lecture Production Modules
Lecture 54G5 Lecture Documentation
Lecture 55G6 Lecture Quality Control
Lecture 56G7 Lecture Product Complaint
Lecture 57G8 Lecture Storage Module
Lecture 58ISO and ISO Audits
Lecture 59Pharmaceutical SOPs Management from regulatory perspective
Lecture 60SOP Automation in Pharmaceutical Industry
Section 6DMF & SMF
Lecture 61Key Consideration for Drug Master File Preparation and Submission 
Lecture 62Practical Understanding on Drug Master File Preparation and Submission
Lecture 63Site Master File - Detailed Understanding 
Lecture 64DMF Completeness Assessment
Lecture 65Drug Master File - Fees
Lecture 66Drug Master File - Global Perspective [Across Different Regions]
Section 7Biosimilar
Lecture 67Introduction to Biosimilar
Lecture 68Biosimilar Approval process
Lecture 69Biological Licensing Application (BLA)
Lecture 70Vaccine development and approval Process
Section 8USFDA Warning Letter & CAPA
Lecture 71USFDA Warning Letter & CAPA
Lecture 72USFDA Warning Letter
Lecture 73Handling of warning letter
Lecture 74Case Study: Warning Letter for The Halol plant of Sun Pharma
Section 9Drug Registration in European Country (Optional)
Lecture 75Introduction to EU Regulation
Lecture 76Orientation to European Countries and National Regulatory Bodies
Lecture 77Overview of EU Regulation
Lecture 78EMEA Procedures
Lecture 79Summary of Product Characteristics
Lecture 80Compassionate Use
Lecture 81Orientation to European Countries and National Regulatory Bodies
Lecture 82MHRA - UK Regulation
Lecture 83EU Orphan Medicinal Products Regulation
Section 10Drug Regulation in GCC countries (Optional)
Lecture 84Regions in Pharma Business : Common Terminologies
Lecture 85GCC Pharma Market
Lecture 86GCC Export – Local Partner
Lecture 87GCC Registration Procedure
Lecture 88Drug Registration in Saudi Arabia
Lecture 89Documentation Required for the GCC countries
Lecture 90Drug Registration in Beherain, UAE, Kuwait, Qatar, Oman
Lecture 91Medical Device Regulation in GCC countries
Section 11Drug Dossier Preparation
Lecture 92Introduction to Common Technical Document (CTD)
Lecture 93Asean Common Technical Document (ACTD)
Lecture 94Electronic Common Technical Document (ECTD)
Lecture 95Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 96Modules on Stability Study 1
Lecture 97Stability Study Test
Lecture 98Module on Interchangeability
Lecture 99Stability Testing of API
Lecture 100Stability Testing of Finished Pharmaceutical Products
Lecture 101Review Test on Stability Testing
Section 12Project Management skills for regulatory professionals (Optional)
Lecture 102Portfolio Management
Lecture 103Importance of market research in pharmaceutical industry
Lecture 104Co-promotion & Co-marketing strategy in pharma industry
Lecture 105Concept of Reverse co-promotion in pharma industry
Lecture 106In-Licensing Vs. Outlicensing
Lecture 107Publication Management from Regulatory perspective
Lecture 108Juxtapid Case Study
Lecture 109New Indication Approval Process and Promotion
Lecture 110OTC Switch
Lecture 111Rx-to-OTC switch
Section 13API Regulatory Affairs
Section 14Drug Registration in ASEAN countries (Optional)
Lecture 113ASEAN Drug Regulatory Affairs
Lecture 114Asean Geography
Lecture 115Drug Registration in Brunei
Lecture 116Drug Registration in Malaysia
Lecture 117Drug Registration in Cambodia
Lecture 118Drug Registration in Mayanmar
Lecture 119Drug Registration in Philippines
Lecture 120Drug 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