Pharmacovigilance & Clinical Trials and Clinical Data Analysis

Call Advisors:

• 9032514145, 9032514147
• 8374141845, 8125516279

One Step Registration link: https://rzp.io/l/pharmacovi2

A Final Batch for those who missed June 27th Batch:

13 Days – 7pm to 9 pm

Sep 12, 13, 14, 15, 16, 17, 19, 20, 21, 22, 25, 26, 27

Pharmacovigilance:

Core topics covered to prepare for a Pharmacovigilance Job

Clinical Trials & Clinical Data Analysis:

Core topics covered to prepare for a Clinical Research & Clinical data Analyst job

Registration Details

Total Course Fee: 3,000 + 18% GST

Mode: Zoom or Zoho Webinar – Link will be emailed on 11th Sep 2022.

Course Objective

Extensive knowledge with detailed understanding of basics imparted to equip you to work at any global Clinical research organizations (CROs) or Pharmaceutical companies or Pharmacovigilance service providers.

Understand the topic to gain the skills, knowledge and competencies of a right candidate for the
Pharmacovigilance sector.

Overview of practical aspects of Pharmacovigilance activities as per the global standards like safety reporting, medical evaluation, casualty assessment, expectedness assessment, case processing, narrative writing, MedDRA etc. to make a student industry ready.

Learn to appear the interview with confidence and grab the best deserved job based on your skillset.

Why attend this training?
Pharmacovigilance & Clinical research is rapidly growing industry globally with growth rate of more than 40% per year. Being a particular specialty, this sector requires trained and skilled workforce, with basic understanding of Clinical Research, Clinical Data Management & pharmacovigilance. This is why, over any unskilled candidates, they prefer them who already understands the basics of safety reporting & it’s impact. In a typical pharmacovigilance department or specialized pharmacovigilance company, there are several positions. Pharmacovigilance offers excellent growth prospects. Here are some of the positions a fresher can get selected for- Drug Safety Associate; Drug Safety Scientist; Aggregate Report Scientist; Pharmacovigilance associate; Safety report specialist etc.

What are the benefits of this course after college?
At the end of this course you’ll gain comprehensive knowledge to the pharmacovigilance basics, clinical research processes, drug development process, regulatory affairs, essential documentation, roles and responsibilities, ethics, monitoring, conduct and management of trials, extensive training on Pharmacovigilance (PV) related issues. In other words, the students taking this course will completely industry ready as freshers.

Syllabus:

Pharmacovigilance

Session 1: Introduction to Pharmacovigilance, history, background
Session 2: Introduction and Evolution of Pharmacovigilance Regulatory And International Agencies
Session 3: Signal Detection and Risk Management Agreegate safety reporting
Session 4: Adverse drug reactions, Individual Case Safety Report, Different types of safety reports
Session 5: Case processing overview (ICSR), Case Receving and Triaging, Labeling Assessment, Causality Assessment
Session 6: Understanding MedDRA and other drug dictionaries, Medical Coding, MeDRA Coding Conventions
Session 7: Narrative writing workshop
Session 8: Understanding workflow, growth and future aspects of PV industry
Session 9: Preparation for Pharmacovigilance interview
Session 10: Question & Answers session

Clinical Trials & Clinical Data Analysis

What is Clinical Research?
ICH GCP guidelines
Consent Forms, Participant information sheets,
Analyzing Clinical data using statistical package
Analyzing Cardiology, Hypertension, Hospital data