Technical Writing (+ Regulatory Aspects) with Irish Quality Centre (IQC)

Overview

This 1.5 day course will be delivered onsite at the NIBRT facility.

This course is tailored for individuals engaged in planning, authoring, reviewing (including proofreading), or approving technical documents. Whether you are conducting research or preparing reports, procedures, proposals, presentations, or other key documentation, this course will help you better understand your audience—and the purpose and context behind your writing.

The optional Day 2 add-on builds on the core training of Day 1 by equipping attendees with technical writing skills tailored for documents and reports subject to regulatory review. Specifically tailored for the pharmaceutical and biopharmaceutical industries, the course equips trainees to confidently prepare documents and reports—including regulatory responses to observations.

Highly interactive and learner-focused, the course is delivered by trainers with many years of experience writing for the life sciences industry.

The course also introduces the topic of AI in technical writing within regulated industries.

Key topics covered

Day One – Technical Writing

By the end of the training, attendees will have strengthened their skills and techniques to:

  • Write clear, concise, audience-focused content;
  • Understand the writing process and the value of effective technical writing;
  • Plan and structure documents from start to finish;
  • Design and apply templates effectively; and
  • Create, edit, review, and approve technical documents with confidence.

 *Delegates will generate a template and create a full report based on tutor instructions. Final draft to be sent to the tutor within seven days

Day Two – Technical Writing with Regulatory Aspects

By the end of Day Two, attendees will have enhanced their skills and techniques for writing regulatory-related documents. They will be able to:

  • Plan, develop, write, review, and revise documents that are clear, concise, and regulatory-focused;
  • Identify and apply relevant regulations, directives, and issued guidelines appropriate to their topic;
  • Define the document’s purpose in alignment with regulatory expectations;
  • Ensure content is Clear, Concise, and Consistent;
  • Use cross-referencing effectively and minimize unnecessary repetition;
  • Maintain a logical flow throughout the document; and
  • Select appropriate reviewers and approvers to support regulatory compliance.

*Delegates will generate a full regulatory report based on tutor instructions. Final draft to be sent to the tutor within ten days.

Who should attend

This training is aimed at those involved in writing documents and reports requiring regulatory review.

Regulatory authorities considered in this course include international life science bodies for example the EMA/HPRA and FDA.

The course is highly interactive, learner based and delivered by trainers with many years writing “for industry”.

What do Attendees Obtain on Completion?

The course is certified by NIBRT, IQC (Irish Quality Centre) and CPD

(8 pts day 1 and 4 pts day 2).

Attendees will receive a relevant CPD certificate upon attending day one, day two, or both

Register

Technical Writing (+ Regulatory Aspects) with Irish Quality Centre (IQC)

Price range: €395.00 through €980.00

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Course Format

Onsite Training at NIBRT

  • 1.5 days onsite training at NIBRT facility

Dates & Price

Dates:
  • Course 1
    24/02/2026

    Day one only (24 Feb 2026)

    585.00

    12 Places Remaining

  • Course 2
    24/02/2026 - 25/02/2026

    Full Course: 24 – 25 Feb 2026

    980.00

    12 Places Remaining

  • Course 3
    25/02/2026

    Day Two only (25 Feb 2026)

    395.00

    12 Places Remaining

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