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Pharmacovigilance Case Handling

Rated 5 out of 5
46
pharmaco case handling

Duration :

2

2 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

Once a drug or medical device reaches the market, safety monitoring becomes an ongoing regulatory obligation. Pharmacovigilance case handling sits at the core of that system, and the quality of each case directly impacts post-market surveillance outcomes.

Developed by Regulatory Affairs experts with qualifications from Northeastern University, Boston, this course equips professionals with the knowledge to handle pharmacovigilance cases accurately and in line with regulatory expectations.

Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, recognized for audit and compliance purposes.

Who Should Enroll?

What You’ll Learn?

  • The scope and importance of pharmacovigilance in post-market safety surveillance
  • How to receive, validate, and follow up on case reports
  • Triage, duplicate search, data entry, and coding assessment procedures
  • Quality management practices and common errors in case handling
  • Regulatory submission requirements and timelines for safety reports

 

Curriculum

Introduction

Lesson 1: Pharmacovigilance and Pharmacovigilance Case Handling: Importance and Major Steps

  • What is Pharmacovigilance?
  • Why is Pharmacovigilance Necessary?
  • Good Pharmacovigilance Practice

Lesson 2: Data Collection – Receipt and Validation of a Case Report

  • Sources of Reports
  • Receiving Data
  • Validation of Reports

Lesson 3: Data Collection in Special Situations

  • Pregnancy or Breastfeeding
  • Pediatric Population
  • Misuse, Abuse, or Overdose of Drug

Lesson 4: Triage, Data Entry, and Assessment

  • Triage
  • Duplicate Search
  • Complete Data Entry

Lesson 5: Maintaining Quality and Avoiding Errors in Case Handling

  • Quality Management
  • Errors in Case Handling

Lesson 6: Transmission to Authorities and Further Action

  • Submission of Safety Reports
  • Submission Time Frames
  • Market Withdrawal

Glossary

Conclusion

Quiz

Author:

Ellena Jefferson
Ellena J. Jefferson
Ellena is a CAPA Manager. She serves as a Training and Quality Advisor with ICONIC plc, a global provider for consulting and outsource development in the pharmaceutical industry. She holds a Masters of Science in Research Administration, Magna Cum Laude from the University of Central Florida. Ellena is a fixer who continuously strives for excellence as a way of life; not just as a job.

Reviews:

Rated 5 out of 5
46
An interesting introduction to pharmacovigilance case and report handling. This has helped the team’s perspective on the necessity of pharmacovigilance. The real-life examples were the icing on the cake.
Regina CTraining Director

$95

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This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

  • Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
  • Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
  • Self-paced : access 24/7 to the course during 12 months at your own rhythm.
  • Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
  • Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
  • Instant Purchase : one click to buy and immediate access. Get certified today.
  • LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
  • HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
  • Procurement optimized : instant Purchase Order, Online payment and PDF Invoice.
  • LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.
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$95.00 / year

$95.00 / year

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