CRED Practical Document Writing and Management

CRED: Document writing and management 31 July – 1 August, TOPRA Office, London

Preliminary Programme

Day 1: The Theory

Time Presentation

Speaker

09:00 Registration and Coffee 09:20 Welcome from TOPRA 09:25 Welcome from Chairman • Overview of the day 09:30 Introduction and AIM •

TOPRA

Joseph Irwin Lakeside Regulatory Consulting Services Ltd

Importance of good writing – Aim, Structure, Language • Style - Accuracy, Brevity, Clarity (ABC) • AIM: o Purpose of document o Who is my reader? What do they know already? o What are they going to do with the information? • Types of Documents – Internal reports, CTD, CTA, IND, briefing packages, responses to questions, cover letters • Tools such as Mind Mapping to gather all the data and information, and agree a “message” • When structure is already defined – ICH M4, Internal, Regulatory Authority (Eg EMA briefing packages) • When to stick to structural templates, when to deviate How to organise/build a document

10:15 Structure •

Joseph Irwin Lakeside Regulatory Consulting Services Ltd

11:00 Coffee

11:20 Language •

Hilary Gray Indivior UK Ltd

What makes a document hard to read? (long words, sentences, paragraphs) • Clear language important when English not first language of reader and/or document will be translated • Readability tools, e.g. Clarity Index, as objective measures of readability vs style preferences • Active v passive tense • Sentences – avoiding flannel and waffle

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