Contact Information: Rapture Biotech D-201, Sector - 10, Noida Uttar Pradesh. Phone , ,

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1 Topics Covered: MODULE 1 Introduction To Pharmacovigilance Terminologies used in Pharmacovigilance ADRs Polypharmacy MODULE 2 Pharmacoepidemiology Iatrogenesis Prescription-event monitoring MODULE 3 SAE Paradoxical effect MODULE 4 Adverse Event Reporting Adverse Event Reporting Requirements 4 Elements of AE case Coding of AE Seriousness determination MODULE 5 Introduction to Signal Detection and Data Mining Mining spontaneous reporting system data

2 Clinical versus computational approaches MODULE 6 Premarketing Clinical Safety and Pharmacovigilance Importance of premarketing clinical safety and pharmacovigilance to ensure Good Pharmacovigilance Practice MODULE 7 Postmarketing Drug Safety and Pharmacovigilance Components of a Good Postmarketing Report MODULE 8 Pharmacovigilance reporting methods- Expedited reporting, Clinical Trial Reporting, Spontaneous reporting, Aggregate Reporting Risk management Causality Assessment MODULE 9 Pharmacovigilance In India The specific aims of the Pharmacovigilance Programmers Improving methods Practical difficulties Causes Of Failure Of Implementation Of Pharmacovigilance In India MODULE 10 Current Problems In Pharmacovigilance Future Aspect Of Pharmacovigilance In India

3 MODULE 11 Live Project

4 Table of Content S.No. Course/Topic Form No. Of Hours Required 1 Introduction To Pharmacovigilance L, P 15 2 Pharmacoepidemiology L, P 15 3 SAE L 15 4 AE reporting L, P 15 5 Introduction to Signal Detection and Data Mining L, P 15 6 Premarketing Clinical Safety and Pharmacovigilance L, P 15 7 Postmarketing Drug Safety and Pharmacovigilance L, P 15 8 Pharmacovigilance reporting methods L, P 15 9 Pharmacovigilance In India L, P Current Problems and Future Aspect Of Pharmacovigilance In India L, P Live project Pc 30 Abbreviations- L- Lecture P- Presentation Pc- Practical

5 Salient Features: Pharmacovigilance is the discipline which takes care of such aspects and is concerned with identifying, validating, quantifying and evaluating adverse reactions associated with the use of drugs thereby improving the safety of medicines in use. This introductory course provides an overview of pharmacovigilance across a spectrum of topics, presenting both US and global perspectives. You will learn the basic concepts, regulatory requirements, and recent trends and approaches, to understanding and communicating a safety profile. The objective is to develop candidates who are experts at monitoring the adverse effects of the drugs which have been released in the market. Course Objectives: Certificate course is a skill development program designed to cover all aspects of Pharmacovigilance and drug safety management. It sensitizes the students and equips them with knowledge on Pharmacovigilance practices worldwide and on the Indian scenario in detail. This course gives young executives an opportunity to remain ahead of competitors in a very nascent yet competitive environment. The prime objective is to provide a high-end training thereby enhancing the employment prospects of the participants. Course Outcome: On the successful completion of this course, a Certificate in Pharmacovigilance will be awarded. Career Prospects: The number of career opportunities continues to grow in this field. The Pharmaceutical industry in India is valued at Rs. 90,000 crore and is growing at the rate of % per annum. India is rapidly emerging as a hub of Global Clinical trials and a destination for Drug Discovery and Development along with for Pharmacovigilance. New Chemical Entities (NCE), high tech Pharma products, vaccines as well as new dosage forms are being introduced in the country which throws up the challenge of monitoring Adverse Drug Reactions (ADRs) over a large population base. Consequently, the demand for qualified

6 Pharmacovigilance and clinical research specialists has grown significantly with supply at present, not being able to match demand. With the advent of more pharmaceutical companies looking at India for their Pharmacovigilance activities, there is an imminent need to develop good professionals in Pharmacovigilance and there is ardent need of trained professionals in Pharmacovigilance. The Pharmacovigilance Course provides professionals with the specialised knowledge required to help biotechnology, medical device, pharmaceutical and food companies manage the Pharmacovigilance processes. Types of Companies Hiring Pharmacovigilance Professionals: The job opportunities are excellent in the areas of pharmacovigilance, regulatory affairs and quality operations in pharmaceutical, biotech, veterinary, cosmetic, food and medical devices, Contract Research Organisations and government. These professionals will find employment as Pharmacovigilance Manager, Drug Safety Specialist, Regulatory Affairs Associates, Regulatory Affairs Assistants, Quality Assurance Associates, Quality Assurance Investigators, Documentation Officers and Medical Information Associates, Drug Inspectors, Drug Controllers, Regulatory Affairs Consultants for Pharma / Biotechnology Industry, Food Safety Scientist, etc. Employability Enhancement Programme : The Employability Enhancement Programme is a course designed to increase your employability. The competition in the Biotech industry is fierce, moreover good jobs are limited in number. Giving a job interview is a skill in itself. This skill set includes certain aspects of personality development in addition to preparing you for technical and aptitude tests. The programme focuses on four major areas that need attention for an interview. These areas are: Personality development Communication skills Interview skills Aptitude and speaking skills We will also work upon the development of professional skills in you like: Team work Project management Crisis handling This programme is aimed at helping you master the art of giving an interview through a standard job screening process.