Skip Main Navigation
Page Content

Save This Event

Event Saved

LEVEL 1 – PHARMACOVIGILANCE TRAINING PROGRAM

Monday, 22 August 2016 at 10:30 - Saturday, 22 October 2016 at 12:30 (IST)

LEVEL 1 – PHARMACOVIGILANCE TRAINING PROGRAM

Ticket Information

Ticket Type Remaining Sales End Price Fee Quantity
ACIPV1
BATCH 1: 10:30 PM to 1 PM
20 Tickets Ended $350.00 $9.34
ACIPV2
For Batch 2: 2PM - 4PM
20 Tickets Ended $350.00 $9.34

Who's Going

Loading your connections...

Share LEVEL 1 – PHARMACOVIGILANCE TRAINING PROGRAM

Event Details

LEVEL 1 – PHARMACOVIGILANCE TRAINING PROGRAM

JOB LEVEL: Pharmacovigilance Associates/Drug Safety Associates/Pharmacovigilance Scientists

INTRODUCTION:

Academy of Clinical Intelligence in collaboration with HAROM Solutions introducing Level 1 technical training program on “Pharmacovigilance Quality Case Processing”. The program include two months of training and one month of internship on live projects by HAROM Solutions for candidates successfully completed the training.

This training program incorporate the unique technicalities and experience combined from our extensive team of industry professionals. The technical training with live experience on the Pharmacovigilance project gives the opportunity for candidates to excel in their Pharmacovigilance career.

TRAINING RECOGNIATION & ACCEPTANCE:

  • WHO Pharmacovigilance Guidelines
  • International Conference on Harmonization
  • Good Pharmacovigilance Practices Modules

TAKE AWAYS:

  • Training completion certificate
  • Internship Experience Letter
  • Recommendation letter for candidates with good performance in Internship
  • Opportunity to get hired in HAROM Solutions

 

DURATION:

TECHNCIAL TRAINING: 8 weeks (Total of 80 hrs)

INTERNSHIP: 4 weeks

TRAINING CONTENT

WEEK 1 — THE THEORY AND PRACTICE OF PHARMACOVIGILANCE:

Sessions: Drug Development Process, Introduction to Pharmacovigilance, Pharmacovigilance Terminologies

Practice: Cases to differentiate AE/ADRs, Serious/Non-Serious, Valid/Non-Valid

WEEK 2 – CASE PROCESSING IN PHARMACOVIGILANCE

Sessions:  Introduction to ADRs - Spontaneous adverse reaction reporting, developing an ADR reporting culture - methods, design, medical content and the importance of reporting, Effective communication in PV, Case Triage and Follow ups, Causality assessment

Practice: Cases to perform triage, Causality assessment

WEEK 3 – REPORTING IN PHARMACOVIGILANCE

Sessions:  Training on Narrative writing, Expedited Reporting, PSUR/DSURs, Signal Management

Practice: Cases to perform narrative writings

WEEK 4 - REGULATORY ASPECTS OF PV

Sessions:  Regulatory guidelines – ICH, GVP, 21CFR, Schedule Y and CIOMS

Practice: Cases for complete processing

WEEK 5 – PHARMACOVIGILANCE CASE PROCESSING ON DRUG SAFETY DATABASE

Sessions:  Introduction to safety databases, Hands on sessions on recording ICSRs, ICSR-Assessment, Data entry and retrieval from ICSR databases, Duplicacy check, Case Bookin

Practice: Cases to perform complete case entries

WEEK 6 – MedDRA Coding

Sessions:  MedDRA Introduction, Coding guidelines, Practical situations for MedDRA coding

Practice: Cases for MedDRA coding

WEEK 7 -8 – PRACTICE ON REAL TIME CASES

  • Pregnancy Cases
  • Death Cases
  • Exception scenarios related to cases
  • Medication Error, Overdose, Misuse cases

WEEK 9-12 – INTERNSHIP with HAROM Solutions

The opportunity to work in close relationship with a drug safety project team, on actual cases with real time case processing, in a cross-functional, multi-cultural and professional environment. 

 

FAQs

Where can I contact the organiser with any questions?

Regarding any training related or payment related query, please contact at 0172-4010894/09988756469 or suil@acitrainings.com

 


Do you have questions about LEVEL 1 – PHARMACOVIGILANCE TRAINING PROGRAM? Contact the organiser

Save This Event

Event Saved

When & Where


Chandigarh
SCO 117-118
Level 1, Sector 17B
Chandigarh, CHANDIGARH 160017
India

Monday, 22 August 2016 at 10:30 - Saturday, 22 October 2016 at 12:30 (IST)


  Add to my calendar

Organiser

ABOUT ACI: 

Academy of Clinical Intelligence is a Corporate Training & Consulting company since 2013. We specialize in Training and Professional Development, for both technical and professional skills. In addition to the extensive industrial experience in Pharmacovigilance and Clinical research industries, we have a pool of experts in our training team specializing in specific areas that serve organizations of numerous industries. 

ABOUT HAROM Solutions:

HAROM solutions is a pre-eminent Pharmacovigilance service provider which offers an immaculate blend of innovation and implementation in order to cater assistance to various pharmaceuticals and healthcare industries in reducing their task of ICSR managment  & reporting by providing them optimal & customized solutions to suit their requirement.

  Contact the Organiser
LEVEL 1 – PHARMACOVIGILANCE TRAINING PROGRAM
Things to do in Chandigarh Course Business

Please log in or sign up

In order to purchase these tickets in installments, you'll need an Eventbrite account. Log in or sign up for a free account to continue.