TypeOnline Course
Student Enrolled2
(1 ratings)
Price$390 / 19500 INR.
Buy NowBook Now
pharmacovigilance training

Introduction

Eligibility

Learning Areas

Duration

Course Fees

Deliverable

Syllabus

Career

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.

Course Code – KPE-C-044

Course Objective: Certificate Course in Pharmacovigilance is conceptualized with vision to create effective Pharmacovigilance for Pharma Industry. This course gives practical knowledge of the functionalities of Pharmacovigilance with practical exposure. The prime objective is to provide a high-end training thereby enhancing the employment prospects of the participants.

Nature of the Course: Distance & e-Learning

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.

Graduates in Pharmacy and Bio-Sciences, Medical Professionals, i.e. Doctors of all disciplines, junior professionals in Pharmaceutical and IT Industry, Clinical Research professionals. 3rd and final year graduation students can also apply for the course.

Course provide detailed understanding on the following –

• Historical Perspectives

• Basic Principles of Pharmacovigilance: Definitions

• Regulations in Pharmacovigilance in Clinical Research

• ADR Reporting and Signal Detection Systems

• Pharmacovigilance in Clinical Research

• Setting up a Pharmacovigilance Centre in Industry

• Causality Assessment of Suspected Adverse Drugs Reactions

• Management of Pharmacovigilance Data

• Risk Management in Pharmacovigilance

• Pharmacoepidemiology

Course provide extensive understanding and simulation on Pharmaceovigilance training.

1 Month

INR 16,500/- (For those enrolling from India) / USD 330 (For payment outside India)

1. Printed Book dispatched to correspondence address (For admission from India). Incasse of admission other than India e-books will be sent to registered email id.

2. Access the E-Modules online with user id and password.

3. Attend lectures online.

4. Access to case study file online

5. All e-study material contains self assessment computer based test.

6. Flexible online final examination.

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

Section 1Introduction : Drug Discovery and R&D Fundamentals
Lecture 1Introduction to drug discovery
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 
Section 2Clinical Research
Lecture 7Clinical Trials Terminologies 
Lecture 8Clinical Trial Protocol Writing
Lecture 9Ethics in Clinical Research
Lecture 10Informed Consent | Practical Training on preparing ICF | Ready Templates
Section 3Pharmacovigilance : ADR
Lecture 11Introduction to Pharmacovigilance
Lecture 12Introduction to Adverse Drug Reactions
Lecture 13ADR: Pharmacology
Lecture 14Controversies on ADR
Lecture 15ADR: Classification
Lecture 16PV and ADR Monitoring
Lecture 17ADR and Related Terminologies
Lecture 18ADR Reporting System 
Lecture 19DoTS
Lecture 204 Elements of AEs
Lecture 21ADR Reporting Limitations
Lecture 22ADR Detection - Pre Marketing Vs. Post Marketing Trial
Lecture 23The Adverse Drug Reaction (ADR) Probability Scale
Section 4Pharmacovigilance Process
Lecture 24Pharmacovigilance Process
Lecture 25PSURs
Lecture 26Risk Management
Section 5Pharmacovigilance regulatory authorities
Lecture 27Introductions
Lecture 28United States
Lecture 29COSTART
Lecture 30MedDRA
Lecture 31Pharmacovigilance Regulation in Emerging economies, including Latin America
Lecture 32European Union
Lecture 33The World Health Organization (WHO)
Lecture 34WHOART
Lecture 35The International Conference on Harmonization (ICH)
Lecture 36The Council for International Organizations of Medical Sciences (CIOMS)
Lecture 37The International Society of Pharmacovigilance (ISoP)
Lecture 38Active surveillance schemes
Lecture 39EudraLex
Section 6Pharmacovigilance Framework
Lecture 40Pharmacovigilance framework
Lecture 41SmPC / SPC
Lecture 42Pharmacovigilance Software
Lecture 43Good Pharmacovigilance Process (GPVP)
Section 7Case Study
Section 8Role of Drug Safety Associates