There will be a REG SIG Meet and Share on 26^th November 13:00 CET with Dr Susan King on “Templates for nonclinical studies”. Please click here to register.

All EMWA members are invited to join the Regulatory Writing SIG’s upcoming Meet & Share on plan and report templates for non-GLP nonclinical studies. You will meet Dr Susan King, nonclinical regulatory and scientific writer at Johnson & Johnson, who will share her experiences developing templates for nonclinical non-GLP study plans and study reports, used primarily for in vivo pharmacology studies.

These nonclinical templates – which Dr King will also make available to attendees – have evolved over time based on feedback from various regulatory agencies. In the absence of clear guidance for the content and structure of nonclinical non-GLP study documentation, this is a useful resource to share with other regulatory writers.

During the session, attendees will be asked for input and feedback, and we’ll discuss how we approach the different sections of these documents. We hope you’ll also share your own experiences with the regulators, whether that is as a freelance writer or working as a regulatory writer at a sponsor or CRO.

About our guest:

Dr Susan King has >10 years’ experience in regulatory writing, 8 of which were as a nonclinical regulatory writer in vaccine development. She has been involved in the preparation of scientific and regulatory documents covering the full clinical development pathway, from discovery activities to first-in-human to marketing authorization applications, responses to questions from regulatory agencies, and annual safety reporting. Her work has also involved improving on data traceability and documentation practices and accuracy in study reporting, with a focus on lean reporting. She also has experience managing a small writing team, allocating responsibilities, providing on-the-job training, and enabling growth and development of team members.