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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.

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Introduction

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Duration

Eligibility

Deliverable

Syllabus

Career

Admission

Course Title: KPE’s Advance Diploma in Pharmacovigilance

Course Objective: Advance / PG Diploma 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.

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 Year

Graduates in Pharmacy and Bio-Sciences, Medical Professionals, i.e. Doctors of all disciplines, junior professionals in Pharmaceutical and IT Industry, Clinical Research professionals.

1. Printed Book dispatched to correspondence address

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

3. Attend lectures with live interactions with faculty.

4. Access to case study file online

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

6. Flexible online final examination.

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

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ADMISSION PROCESS

Section 1R&D Process - Learning on Drug Discovery Development and Regulation
Lecture 1Introduction
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 10Expedited Program
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 Designation 
Lecture 18Advance Learning on 505B2 Pathway
Section 2Clinical Research - Pre-marketing Trials
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 3Introduction: Pharmacovigilance
Section 4Adverse Effect : Detailed Study
Lecture 26ADR - Introduction
Lecture 27ADR - Pharmacology
Lecture 28Controversies on ADR
Lecture 29Classification - ADR
Lecture 30PV and ADR Monitoring
Lecture 31ADR and Related Terminologies
Lecture 32ADR Reporting System 
Lecture 33DoTS Priciple
Lecture 34Four Elements of AEs
Lecture 35ADR Reporting Limitations
Lecture 36ADR Detection - Pre Marketing Vs. Post Marketing Trial
Section 5Pharmacoviglance process
Lecture 37Why Pharmacovigilance Process
Lecture 38PSURs
Lecture 39Risk Management - Pharamcovigilance
Section 6Pharmacovigilance regulatory authorities
Lecture 40Introduction
Lecture 41USFDA
Lecture 42COSTART
Lecture 43MedDRA
Lecture 44Pharmacovigilance Regulation in Emerging economies, including Latin America
Lecture 45Pharmacovigilance in Europe
Lecture 46WHO
Lecture 47WHOART
Lecture 48The International Conference on Harmonization (ICH)
Lecture 49The Council for International Organizations of Medical Sciences (CIOMS)
Lecture 50The International Society of Pharmacovigilance (ISoP)
Section 7Clinical Trial & Research - All Terminologies
Lecture 51Clinical Research (Lecture 1-11)
Lecture 52Clinical Research Protocol Writing
Lecture 53Ethics in Clinical Research
Lecture 54Informed Consent
Section 8Regulatory body adopting pharmacovigilance program
Lecture 55Active surveillance schemes
Lecture 56EudraLex
Section 9Pharmacovigilance Framework
Section 10The Summary of Product Characteristics (SmPC, SPC)
Section 11Pharmacovigilance Software
Lecture 59introduction
Lecture 60Effectiveness of pharmacovigilance software
Section 12Pharmacovigilance in India
Section 13Good Pharmacovigilance Process (GPVP)
Section 14Case Study: How ADR is monitored?