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Drug Information & Pharmacovigilance

Accurate information and timely reporting protect patients.

Why It Matters

We provide evidence-based drug information, medical writing, ICSR processing and safety narratives aligned with PvPI and international pharmacovigilance practice.

Who It Is for

Pharma companies, CROs, hospitals and marketing-authorisation holders.

See the service Brochure

What We Cover

ICSR processing, safety narratives and MedDRA adverse-event triage
Medical inquiry handling and evidence-based drug information
Product monographs and investigator brochures
Clinical study reports (ICH E3) and manuscripts

Benefits

On-Time Reporting

Cases triaged against regulatory timelines.

Quality Narratives

Clear, consistent and medically accurate.

Evidence-Based Answers

Referenced responses to medical inquiries.

Scalable Support

Specialists from our network when volumes rise.

Related Courses

High demand

Drug safety

Pharmacovigilance & Drug Safety Operations

Case processing from intake to narrative: triage, MedDRA coding, causality and reporting timelines.

6 weekends
Live online with recordings · Next batch: on request
Pharmacy, life sciences and medical graduates

What you will learn

ICSR intake and the four validity criteria
Seriousness, expectedness and triage
MedDRA coding and causality (WHO-UMC, Naranjo)
Safety narrative writing
Expedited reporting timelines, PSUR/PBRER overview and PvPI

Regulatory, quality & writing

Medical & Scientific Writing

Write the documents trials depend on: protocols, CSRs, safety narratives, manuscripts and reviews.

5 weekends
Live online with recordings · Next batch: on request
Pharmacy, life sciences and medical graduates

What you will learn

Protocol synopsis and ICF writing
Clinical study reports (ICH E3)
Safety narratives
Manuscripts, case reports and literature reviews
Referencing and plagiarism checks

Regulatory, quality & writing

Medical Coding: MedDRA, WHO-DD & ICD-10

Code adverse events, medications and diagnoses accurately for trials, safety and healthcare.

4 weekends
Live online with recordings · Next batch: on request
Pharmacy, life sciences, nursing and medical graduates

What you will learn

MedDRA hierarchy from SOC to LLT
WHO Drug Global coding
ICD-10-CM fundamentals
Coding conventions and quality checks
Practice on real-format cases

Have a Question about This Area?

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