About Courses

Patient safety is essential throughout the drug development process, which explains why drug safety and Pharmacovigilance are becoming more important worldwide. For example, drug reactions (ADRs), which can harm patients, may be reduced by pharmacological research. Pharmacovigilance is the study of ‘the science and activities related to detecting, analyzing, understanding, and preventing adverse effects or any other possible drug-related issues.’ It combines pharmacology, epidemiology, clinical medicine, data management, drug legislation, and communication.

At Pharma Educare, we provide you with the pharmacovigilance courses you need to advance in this field. Entry Level Certification Course on Pharmacovigilance and Pharmacovigilance Certification Course for Professionals are two courses we offer. 

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  • Duration 1-2 Months
  • Language English
  • Speaker TBA
  • Certification Attendance Certificate

Description

This course will provide a comprehensive overview of how to manage and report safety information according to the latest international guidelines. The topics include audits, expectations for risk-based inspections (RBI), compliance with drug safety regulations like product approval/licensing agreements from Europe Union countries or other regions where they exist; also providing an introduction to Product Safety Reviews – its purpose function(incorporating CIOMS III requirements) as well new changes brought about by 2nd revision ICH E2C standards that are applicable today’s industry practices making them essential skills every company needs!

Courses Outcomes

Upon finishing this course, you will be able to:

  • Recognize the fundamentals and intricacies of pharmacovigilance and drug safety.
  • Recognize the reporting database for pharmacovigilance (e.g., Signal Detection, Risk Assessment, and Evaluation)
  • Demonstrate an understanding of PV Guidelines (ICH E2C, WHO, etc.) and their practical applications in the workplace.
  • Understand risk management concepts, tools, and methods for identifying and assessing risks.
  • Examine signal management for causation assessment using a critical approach.
  • Improve your writing skills when it comes to producing PV reports.

Who Should Attend

This course is required for pharmacovigilance, regulatory affairs, and drug safety professionals. It’s also useful for those looking to enter the field of pharmacovigilance. Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc., MBBS / BDS), pharmaceutical and healthcare industry regulators, and academic research centers.

  • Duration 3-4 Months
  • Language English
  • Speaker TBA
  • Certification Attendance Certificate

Description

This course is based on 21 CFR guidelines, designed to provide participants with an in-depth understanding of pharmacovigilance activities and how they are integrated into the drug development process. The topics covered include pharmacovigilance audits (RBI, PLA), risk management (REMS, CAPA, RMP, SMP), signal detection (AERS, VRMPT, RMP, SMP, SPE, PSR, etc), and product safety reviews (PSR, PSUR) based on GVP guidelines. In addition, you will also get a 30 hours hand on training on PvEdge software.

Courses Outcomes

Upon finishing this course, you will be able to:

  • Demonstrate an understanding of pharmacovigilance activities and their role in the drug development process.
  • Understand how to conduct a pharmacovigilance audit.
  • Understand how to manage risk in pharmacovigilance.
  • Demonstrate an understanding of signal detection in pharmacovigilance.
  • Demonstrate an understanding of product safety reviews in pharmacovigilance.
  • Understand how to use PvEdge software for pharmacovigilance activities.

Who Should Attend

This course is required for pharmacovigilance, regulatory affairs, and drug safety professionals. It’s also useful for those looking to enter the field of pharmacovigilance. Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc., MBBS / BDS), pharmaceutical and healthcare industry regulators, and academic research centers)