Course overview
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 two-day medical writing course will help you to improve your skills and achieve this standard.
CPD Hours: 12
Course Content
- Day 1
- Day 1 - Fundamentals of Regulatory Medical Writing
- Introduction to regulatory medical writing
- Regulatory environment and guidelines
- Regulatory documents
- Day 2
- Day 2 - Scientific Advice and Marketing Applications
- Briefing documents
- Importance of real-world evidence and patient-centred outcomes
- The Common Technical Document
Speakers
Cheryl Roberts
Cheryl is currently the Global Head of Medical Writing at BioMarin Pharmaceutical Inc., and specialises in medical writing for serious and life‑threatening rare diseases. She joined the pharmaceutical industry in 2001 in drug development, and continued in positions in medical editing and medical writing in both the pharmaceutical and consultancy industry. She holds a degree in Medical Biology and a Masters in Neuroscience. Cheryl has been an approved workshop leader for the European Medical Writers Association since 2015 and gives training on subgroup analyses and orphan medicinal products.
Who Should Attend
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 course is on clinical research, many of the principles will also apply to other types of reports, including pre-clinical, CMC and veterinary documentation.
This practical course 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.
