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Introduction to Good Pharmacovigilance Practice (GVP)

 5/5

63

Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Gain a recognized and traceable certificate after completing the course :

All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.

Description:

Pharmacovigilance contributes to the protection of patients and public health in an essential way. It is highly mandatory for life sciences manufacturers to follow GVP with programs in place that focus on risk assessment and management. This course is based on the official GVP guidelines and is a complete training program for all individuals that need a refresher. You will learn about identification and assessment of safety signals for good reporting practice, as well as the features of a good case report. At the end you’ll be able to develop a pharmacovigilance plan.

This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum:

Lesson 1: Identifying Safety Signals

Features of a good case report

Lesson 2: Signal Investigation through Observational Studies

Pharmacoepidemiologic Studies
Regisitries
Surveys

Lesson 3: Interpreting Safety Signals

Lesson 4: How to Develop a Pharmacovigilance Plan

Glossary

Evaluation

Author:

Marc Estrow

Marc Estrow is an Oxford University graduate from the department of pharmacology with over 20 years’ experience in drug safety & pharmacovigilance, who specializes in global safety compliance, business process improvement and signal detection. He has worked with over 50 clients in the US, France and United Kingdom. He is a featured speaker with the FDA at conferences and webinars on drug safety topics including auditing and reporting.

Reviews:

 5/5

63

Marc Estrow shared a lot of knowledge and experiences that put the regulation / expectations from agencies in context, and makes the course relevant and profitable.

$60

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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.