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.
Benefits of attending
- Gain in-depth knowledge on general writing and data presentation skills, specifically in the kind of documents most frequently encountered in clinical research
- Understand the international guidelines and standards
- Explore both the theoretical and practical aspects of writing for regulatory authorities through illustrative examples
Certifications
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Day 1
Day 1 - Fundamentals of Regulatory Medical Writing
Introduction to Regulatory Medical Writing
- Overview of medical writing in the pharmaceutical industry
- Types of documents
- Project management
- Working cross-functionally
- Document reviews
- Quality checks
Regulatory environment and guidelines
- Regulatory agencies and key regulatory guidelines
- Drug development lifecycle and regulatory milestones
Regulatory documents
- What are they and why are they needed?
- Developing the protocol and ICFs
- Developing the CSR
- Developing the Investigator’s Brochure
- Developing the DSUR
Day 2
Day 2 - Scientific Advice and Marketing Applications
Briefing documents
- What are they?
- Why are they needed?
- How are they developed?
Importance of real-world evidence and patient-centred outcomes
The Common Technical Document
- Introduction to clinical submission dossiers
- Writing the clinical overview & the clinical summary
Course Provider
Cheryl Roberts-Vitalis,
BioMarin Pharmaceutical Inc.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
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.
