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Home/All Courses/Pharmacovigilance & Drug Safety/Adverse Event Reporting: MHRA & EMA Requirements
ADVANCEDMHRA & EMA Aligned

Adverse Event Reporting: MHRA & EMA Requirements

Master SAE and SUSAR reporting timelines for UK and EU trials

โ˜…โ˜…โ˜…โ˜…โ˜…
4.9/ 5 ย ยทย  100% Money-back Guarantee
5+ hours of learning2 modulesCertificate includedOnline & Self-paced
View Syllabus

Pharmacovigilance & Drug Safety

Duration5+ hours
LevelAdvanced
LanguageEnglish (UK)
Certificateโœ“ Included
AccessLifetime

Trusted by professionals working at

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What You Will Learn

โœ“Apply 7-day and 15-day SUSAR reporting timelines correctly
โœ“Prepare compliant SAE narratives
โœ“Use EudraVigilance for EU submissions
โœ“Understand post-Brexit dual reporting obligations

Programme Structure

5+hours of learning
2modules
4lessons
โœ“Certificate included
1

Module 1: Introduction & Foundations

2 lessons

โ–พ
โ–ถ๏ธWelcome & Course OverviewFree Preview8min
๐Ÿ“Key Concepts & Terminology
2

Module 2: Core Principles & Practice

2 lessons

โ–พ
โ–ถ๏ธRegulatory Framework15min
๐Ÿ“Practical Application

Your Instructor

D

Dr. Sarah Mitchell

Senior Clinical Research Associate, ACRP-CP

Dr. Mitchell has 12+ years experience in oncology and cardiovascular clinical trials across the UK and EU.

ACRP-CPMSc Clinical ResearchICH GCP Certified

Prerequisites

  • โ†’Introduction to Pharmacovigilance recommended

Why Clinical Research Nexus?

โœ“ Globally recognised & industry-aligned certification

โœ“ Designed for UK and international clinical research practice

โœ“ Self-paced โ€” learn on your schedule

โœ“ Lifetime access to course materials

โœ“ Certificate issued on successful completion

โœ“ MHRA and ICH GCP E6(R3) aligned content

Frequently Asked Questions

Is this course suitable for beginners?+
This course is designed for professionals with some clinical research background looking to advance. Check the prerequisites section above for specific requirements.
How long do I have access to the course?+
Once enrolled, you have lifetime access to all course materials, including any future updates.
Will I receive a certificate?+
Yes. A certificate of completion is issued upon successfully passing the final assessment. Certificates are verifiable online and include a unique verification code.
Is this course recognised in the UK?+
Yes. All courses are aligned with MHRA guidelines and ICH GCP E6(R3) standards applicable in the United Kingdom and internationally.

Enrol Today

Adverse Event Reporting: MHRA & EMA Requirements

ยฃ100.00

One payment ยท Lifetime access

โฑDuration5+ hours
๐Ÿ“šModules2 modules ยท 4 lessons
๐ŸŒLanguageEnglish (UK)
๐Ÿ…CertificateIncluded
๐Ÿ”„AccessLifetime
๐Ÿ“ฑFormatOnline, Self-paced

5-day money-back guarantee

Topics

SAESUSAREudraVigilanceMHRAEMA