We provide online training by certified professionals. We offer Online Training, which has a great trend in current healthcare IT & clinical research industry and helps the learners to enhance their comprehension with fresh information.
We also offer good quality tips to improve their acquaintance more in the healthcare IT Training online to contend with today’s competitive world. We train the students in different directions to be the paramount in the online healthcare training field as to make them finest amongst with the latest technology. We have highly practiced and proficient faculty to polish the trainees in a contemporary manner to amplify their style of learning and grabbing the existing issues as fine as that helps them to grow intelligent in this field. Please go through the pharmacovigilance hands on training on Oracle ARGUS software course details.
Course Description:
This program provides fundamental understanding of the function of Pharmacovigilance in the drug development process. The curriculum focuses on core Pharmacovigilance function and their underlying principles. This program takes learners one step forward towards advanced pharmacovigilance processes and addresses increased emphasis on quality control, handling of safety data reporting.
Course Content for Pharmacovigilance Training:
Clinical research overview – Drug discovery to Submission
Clinical Research Organization / Contract Research Organization
Basics of clinical research and Pharmacovigilance
Scope of the Pharmacovigilance
Pharmacovigilance Process
Pharmacovigilance regulations
Different types of safety reports
Different phases of clinical Trials
Adverse events and its types
Different sources of Adverse events reporting
Different types of AE reporting Forms
Expedited reporting and its timelines
Assessing Expectedness/Labeledness/Listedness
Labeled vs. Listed
Company Core Data Sheet (CCDS)
Company Core Safety Information (CCSI)
Assessing Expectedness/Labeledness/Listedness
Labeled vs. Listed
Company Core Data Sheet (CCDS)
Company Core Safety Information (CCSI)
Different departments working on Pharmacovigilance
Roles and responsibilities of case receipt unit
Four factors for the reportable case
Seriousness criteria of adverse event
Expectedness or Listedness of adverse event
Causality assessment of the adverse event
Introduction to safety databases and different types
Introduction to MedDRA and WHODD
Narrative writing
Case quality check, Medical review and its submission.
Practical Demonstration of Oracle Argus Safety Database End user Training
Course content:
Data Entry Training
Case Book in
Work list Intake
Work list Training
New, Open
Case Processing Training
General Case form
Patient
Product
Event
Analysis
Activities
Additional Info
Regulatory Reports
Case Forward/Return
Medical Review
Coding Review
E2B Validation
Data Collection & Processing
Receive cases from various sources
Case Initiation
Data Entry, Coding, Labeling, Narrative Writing
Quality Check
Scientific/Medical Assessment of case
Software used for training
Oracle Argus Safety Database
Periodic Safety Update Reports (PSUR)Training
The focus of the lectures will be mainly on the following topics:
History and rationale for PSURs
Changes to PSURs under new EU PV Legislation – compare and contrast with current requirements
Format and content of a PSUR
Planning and writing a PSUR
Reference Safety Information for PSURs
Calculation of exposure data for PSURs
How to gather and evaluate data for PSURs
Regulatory aspects of PSURs
For more information, please contact Brainmeda at training@brainmeda.com
Visit www.brainmeda.com for more information.
Brainmeda Advantages:
Oracle Argus Safety Database – Latest Production Version 7.0
• Hands on live projects
• Industry SOPs based training
• Trainers with minimum 5 years experience
• 24 hours access to application lab
Contact No: 91-9632654650
