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Signal Detection and Management in Pharmacovigilance

 5/5

3

Duration :

1

1 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:

Explore the essential aspects of Signal Detection and Management in Pharmacovigilance with our specialized course. Learn key techniques to identify and manage adverse drug reaction (ADR) signals, ensuring patient safety and regulatory compliance in the pharmaceutical sector.

Who should enroll?

This course is perfect for professionals in pharmacovigilance, safety officers, and experts in regulatory affairs or clinical safety. It’s also ideal for quality assurance specialists in the pharmaceutical industry, as well as anyone aiming to deepen their knowledge of signal detection and management to uphold patient safety standards.

Topics outlined in the course:

Understanding the importance of signal detection in ensuring patient safety.
Key differences between detecting new ADRs and comprehensive signal detection.
Exploring various types of signal detection techniques used in pharmacovigilance.
Step-by-step overview of the signal management process.
Practical signal detection practices and sources of signals in pharmacovigilance.

This comprehensive course offers an in-depth examination of Signal Detection & Management in Pharmacovigilance, elucidating the essential elements of laboratory management systems in a highly interactive format. Each session integrates real-life examples and assessments to facilitate a comprehensive and applied learning experience. Upon completion, participants will receive a globally acknowledged Signal Detection & Management in Pharmacovigilance training certificate, accredited with CPD/CEU credits..

Curriculum:

Introduction

Lesson 1: Why is Signal Detection Important?

Lesson 2: What is the Difference Between Detecting New Adverse Drug Reactions and Signal Detection?

Lesson 3: Types of Signal Detection in Pharmacovigilance

Lesson 4: Signal Management Process

Lesson 5: Sources of Signals in Pharmacovigilance

Lesson 6: Signal Detection Practices

Conclusion

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 at conferences and webinars on drug safety topics including auditing and reporting.

Reviews:

 5/5

3

This certified course gave me the skills to efficiently manage adverse drug reactions and enhance patient safety.

$95

Participant(s):

Buy now

Large group ? Request a quote !

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.