Browse and fill a basket without an account. You must sign in as a member before you can check out.
DDF23 Drug Safety for Medical Writers Part 2: Laboratory Data
Who it is for
This workshop is intended for medical writers who are new to writing the safety sections of clinical study reports or related safety summaries.
What it covers
The role of the medical writer in preparing summaries of safety data are to take a large amount of information and to present the most important points in a useful and understandable format. The challenge for the writer is to identify what is important and to answer the readers’ questions before they have been asked. The collection of laboratory, vital sign and ECG data on a drug begins at the clinical trial level. All safety summaries are built upon this starting point. The aim of the workshop is to bring the data to life so that the writer can present safety data that are interesting to the reader.
Gillian Pritchard (Director, Sylexis Limited, UK) is a regulatory medical writer
specialising in writing clinical evaluation reports and literature reviews for medical devices. She has worked on medical devices for orthopaedic, cardiology,
ophthalmology, gynaecology, wound closure, diabetes and weight loss
indications. Gillian trained as a physician and has many years’ experience as a research physician in academia and phase I-II contract research; as a clinical project manager of phase III trials with Pfizer GRD; and also with a pharmaceutical and medical devices consultancy. In 2006 Gillian established Sylexis Ltd. to provide
regulatory writing services for pharmaceutical and medical device clients. Gillian gives workshops on literature reviews, clinical evaluation reports, drug safety
(adverse events and laboratory safety), ICH-GCP and on moving from pharma to medical device writing. She was EMWA Treasurer from 2009 to 2013 and is a member of the Medical Device Special Interest Group (MD SIG).
Wendy has more than 30 years’ experience of clinical research and medical writing in the pharmaceutical industry. She started her career as a clinical research
associate; writing protocols, preparing related study documents, managing studies, and writing clinical study reports. She has been working successfully as a freelance medical writer since 2002 and specialises in clinical and regulatory documents. She has provided commercial and academic training on medical writing. Wendy was
EMWA Education Officer 2003–2005, served on the EMWA Professional Development Committee (EPDC) for 5 years, was Treasurer of EMWA from 2005–2009, and has been Co-Treasurer with Julia Cooper since autumn 2024.
Sign in to check out
You can browse and fill a basket without an account. Sign in here to complete checkout — you stay on this page.
Reset your password
We will email a reset link. This page stays open.
Booking is for EMWA members
You are signed in, but this account does not have an active membership. You can keep browsing. Join EMWA to book — we will not send you away automatically.
Registration fee first
The conference registration fee (€50) must be in your basket before any session can be added. It is one off and covers the opening session and the plenary.
Terms and conditions
Changes to registration
Changes may be made to workshop or seminar choices after booking (that is, a cancellation of one workshop or seminar choice and replacement by another), for an administrative fee of €27, plus any difference in price between the choice of workshops or seminars. Workshops, seminars and lunchtime sponsored sessions may be added to your original registration (subject to availability) at any time, without an administrative fee by contacting info@emwa.org. All changes are subject to availability.
Cancellation of attendance
If you wish to cancel your attendance at the conference, a refund, minus an administration fee of €162, will be made provided your cancellation is made in writing to EMWA head office before 20 October 2026. No refunds will be made after this date.
Payments
Invoices must be settled by bank transfer in Euro, or paid by card through Stripe. All fees are payable in advance. Full payment is due by 30 October 2026. If payment has not been received, EMWA reserves the right to request payment and cancel registration.