TypeOnline Course
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Price$330
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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 1Welcome Session !!!
Section 2Introduction – Pharmacovigilance
Section 3Adverse Effect: Introduction
Section 4ADR - Pharmacology
Section 5Some Controversies related to adverse effect
Section 6Classification of adverse reactions
Section 7Why pharmacovgilance process?
Section 8Adverse Event Reporting
Section 9PSURs
Section 10Risk Management
Section 11Pharmacovigilance regulatory authorities
Section 12International collaboration on pharmacovigilance
Section 13Clinical Trial
Section 14Regulatory body adopting pharmacovigilance program
Section 15Pharmacovigilance framework
Section 16The Summary of Product Characteristics (SmPC, SPC)
Section 17Pharmacovigilance Software
Section 18Pharmacovigilance in India
Section 19Good Pharmacovigilance Process (GPVP)
Section 20Case Study: How ADR is monitored in Malyasia?