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.
Certifications:
- CPD: 18 hours for your records
- Certificate of completion
Agenda
Day 1
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
Day 2
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
More on improving readability, for example:
- Prepositions
- Abbreviations
Summary Documents
- Overview including abstracts and synopses
Day 3
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
Speakers
Mr Barbara Grossman ,
Biochemist ,
Hawkeye Medical LimitedBarbara Grossman has a passion for proofreading, quality control, and education. She is a biochemist by training and a medical writer, editor and teacher by profession, with 20+ years’ experience in the pharmaceutical industry. Before starting her own medical writing and consultancy business (Hawkeye Medical Limited), she built up and managed the medical writing group at Covance, the contract research organisation, working in a wide range of therapeutic areas. She has given professional development training at educational institutions and organisations such as the DIA (Drug Information Association – Europe and USA), EMWA (European Medical Writers Association) and NICE (National Institute for Health and Care Excellence), and has led many company-internal training courses. Barbara is an honorary member of EMWA, was Treasurer 1998–2005, has been an EMWA workshop leader since 2001, served on EMWA’s Education Committee 2010–2018, was the Education Officer for 2 years until 2016, and since May 2019 is EMWA’s President. In addition, she is an Associate Editor of Medical Writing, EMWA’s journal.
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.
