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DDA36 -The non-clinical elements of the eCTD
Who it is for
The course is intended for medical writers with little or no experience of writing clinical submission dossiers although participants should be familiar with the non‑clinical and clinical development process. Preference is that participant also have had some experience of writing either non-clinical study reports or taken the EMWA course on non-clinical study reports.
What it covers
The workshop will provide an overview of the structure of the nonclinical elements of the CTD and place in the context with the other clinical and CMC elements. The workshop will aim to introduce the type and nature of non-clinical data and the relevant placement of the studies in to the respective 2.6 sections. The workshop will detail the structure and format of the Module 2.4 with best practices from the guidelines and from examples.
Claire is a Senior Director of Global Submissions at Veristat. She worked in pharmaceutical and academic research before and after her PhD in immunology and oncology. Claire has worked within the pharmaceutical and CRO industry in a number of clinical and medical roles including medical information and sales/marketing. After leaving the big smoke in London, she decided on a career in medical writing. Claire has been a medical writer since 2007 and worked as a MW Manager at Trilogy and ICON before joining Certara as one of the Submission Leads. She has a wide range of experience and a particular interest in regulatory documents covering various therapeutic areas.
Kelly is a Senior Director of Global Submissions at Veristat and has over 20 years of industry experience as a Regulatory Medical Writer. After her PhD in Biomedical Sciences, Kelly transitioned into Regulatory Medical Writing and has worked her entire career at specialist medical writing service providers, working with many different clients from small to large pharmaceutical companies across multiple therapeutic areas. During her career, Kelly has led a wide range of medical writing projects, encompassing submission-level, study-level and drug safety documents, and works on both non-clinical and clinical documents. Kelly has been responsible for training numerous medical writers during her career and, in her current role as one of the Submission Leads at Veristat, she continues to author documents, but also advises clients on best practices for writing high-quality submission-ready regulatory documents.
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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.