Dublin, Dec. 10, 2024 (GLOBE NEWSWIRE) -- The "Successful Medical Writing - from Protocol to CTD Training Course" has been added to ResearchAndMarkets.com's offering.
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 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
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.
Course Agenda:
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 - 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
For more information about this conference visit https://www.researchandmarkets.com/r/oigzfw
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