Successful Medical Writing – from Protocol to CTD Training Course

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

27-29 November 2024 »
from £1349

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Format: Live online
CPD: 18 hours for your records
Certificate of completion

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Course overview

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals. This process largely relies on the quality of documentation submitted to the regulatory authorities, and a high standard of medical writing plays a vital role in ensuring a positive outcome. This intensive three-day medical writing course will help you to improve your skills and achieve this standard.

Aims and objectives

This event combines presentations from our expert faculty with practical exercises to provide a thorough introduction to the basics of medical writing that goes beyond the usual ‘overview’ courses. It will provide in-depth training in general writing and data presentation skills, and specifically in the kind of documents most frequently encountered in clinical research.

You will learn both the theoretical and practical aspects of writing for regulatory authorities as well as the sensible use of international guidelines, standards and useful writing tips. Many illustrative examples will be used, drawn from the course leaders’ wide experience of the pharmaceutical industry.

This course is part of our Medical Writing Training Courses series that aims to equip delegates with the tools and techniques needed to thrive within an ever-evolving industry.

Who should attend?

The course will be of interest to all those in the pharmaceutical industry who prepare research reports and documentation intended for regulatory authorities. Although the focus of the seminar is on clinical research, many of the principles will also apply to other types of reports, including pre-clinical, CMC and veterinary documentation. The practical training will benefit not only those new to medical writing but also those wishing to perfect their existing writing skills, including full-time medical writers and those who only occasionally write research documentation or regulatory submissions.

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This course will cover:

Overview of writing: substantive and technical aspects

Helping your reader

The Protocol

Developing the protocol
The most important clinical document?

The CSR

General aspects
CSR templates
Content – results-independent text

The CSR continued

Content – patient information & efficacy

Completing the CSR

Content – safety & discussion

Improving readability, for example:

Brief overview of punctuation specifics affecting readability
Verb force

Designing tables for clinical documents

Table types
Elements of table design

Summary Documents

Overview including abstracts and synopses

The Common Technical Document

Introduction to clinical submission dossiers
Purpose & types of clinical summary documents
Writing the clinical overview & the clinical summary
Recent regulatory developments: really a common technical document?

Project Management

Improving the process, for example considering:
- Timelines
- Document review

Quality aspects

Just how perfect does your document need to be?

Final checks

Proofreading: just a spell check?

Additional writing tips and tools

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NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

27-29 November 2024

Live online

09:15-17:30 UK (London) (UTC+00)
10:15-18:30 Paris (UTC+01)
04:15-12:30 New York (UTC-05)
Course code 14071

GBP 1,349 1,649
EUR 1,939 2,359
USD 2,201 2,669

Until 23 Oct

3 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.