TypeOnline Course
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(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:

  • Interactive e-lectures (virtual classroom)
  • 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)
  • The Internationally Accredited course – Approved by International Association of Distance Learning (IADL), UK
  • Personalized web page
  • 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:

• CPD Points – Gain Continuing Professional Development (CPD) Points, accredited by The International Association of Distance Learning of the United Kingdom.

• 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 37Evergreening - Patent Life Extension Strategies
Lecture 38Drug Repurposing
Lecture 39Pay For Delay Strategy
Lecture 40Pediatric Exclusivity - Case Study
Lecture 41Compulsory Licensing
Lecture 42Technology Licensing
Section 5Good Manufacturing Practices
Lecture 43Definition of GMP
Lecture 44Certification Pharmaceutical Companies / Plants
Lecture 45Introduction to Good Manufacturing Practices
Lecture 46G1 Lecture Premises & Plant Layout Designing
Lecture 47G2 Lecture Sanitation and Hygiene
Lecture 48G3 Lecture Equipment Modules
Lecture 49G4 Lecture Production Modules
Lecture 50G5 Lecture Documentation
Lecture 51G6 Lecture Quality Control
Lecture 52G7 Lecture Product Complaint
Lecture 53G8 Lecture Storage Module
Lecture 54ISO and ISO Audits
Lecture 55Pharmaceutical SOPs Management from regulatory perspective
Lecture 56SOP Automation in Pharmaceutical Industry
Section 6DMF & SMF
Lecture 57Drug Master File
Lecture 58Site Master File
Lecture 59Practical Training on preparing DMF and SMF
Section 7Biosimilar
Lecture 60Introduction to Biosimilar
Lecture 61Biosimilar Approval process
Lecture 62Biological Licensing Application (BLA)
Lecture 63Vaccine development and approval Process
Section 8USFDA Warning Letter & CAPA
Lecture 64USFDA Warning Letter & CAPA
Lecture 65USFDA Warning Letter
Lecture 66Handling of warning letter
Lecture 67Case Study: Warning Letter for The Halol plant of Sun Pharma
Section 9Drug Registration in European Country (Optional)
Lecture 68Introduction to EU Regulation
Lecture 69Orientation to European Countries and National Regulatory Bodies
Lecture 70Overview of EU Regulation
Lecture 71EMEA Procedures
Lecture 72Summary of Product Characteristics
Lecture 73Compassionate Use
Lecture 74Orientation to European Countries and National Regulatory Bodies
Lecture 75MHRA - UK Regulation
Lecture 76EU Orphan Medicinal Products Regulation
Section 10Drug Regulation in GCC countries (Optional)
Lecture 77Regions in Pharma Business : Common Terminologies
Lecture 78GCC Pharma Market
Lecture 79GCC Export – Local Partner
Lecture 80GCC Registration Procedure
Lecture 81Drug Registration in Saudi Arabia
Lecture 82Documentation Required for the GCC countries
Lecture 83Drug Registration in Beherain, UAE, Kuwait, Qatar, Oman
Lecture 84Medical Device Regulation in GCC countries
Section 11Drug Dossier Preparation
Lecture 85Introduction to Common Technical Document (CTD)
Lecture 86Asean Common Technical Document (ACTD)
Lecture 87Electronic Common Technical Document (ECTD)
Lecture 88Advance Practical Training on Dossier Preparation focusing on drug registration in export countries
Lecture 89Modules on Stability Study 1
Lecture 90Stability Study Test
Lecture 91Module on Interchangeability
Lecture 92Stability Testing of API
Lecture 93Stability Testing of Finished Pharmaceutical Products
Lecture 94Review Test on Stability Testing
Section 12Project Management skills for regulatory professionals (Optional)
Lecture 95Portfolio Management
Lecture 96Importance of market research in pharmaceutical industry
Lecture 97Co-promotion & Co-marketing strategy in pharma industry
Lecture 98Concept of Reverse co-promotion in pharma industry
Lecture 99In-Licensing Vs. Outlicensing
Lecture 100Publication Management from Regulatory perspective
Lecture 101Juxtapid Case Study
Lecture 102New Indication Approval Process and Promotion
Lecture 103OTC Switch
Lecture 104Rx-to-OTC switch
Section 13API Regulatory Affairs
Section 14Drug Registration in ASEAN countries (Optional)
Lecture 106ASEAN Drug Regulatory Affairs
Lecture 107Asean Geography
Lecture 108Drug Registration in Brunei
Lecture 109Drug Registration in Malaysia
Lecture 110Drug Registration in Cambodia
Lecture 111Drug Registration in Mayanmar
Lecture 112Drug Registration in Philippines
Lecture 113Drug 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