AMWA Certificate in Regulatory Writing Core Knowledge

Earn the newest professional development certificate from the American Medical Writers Association (AMWA). The AMWA Certificate in Regulatory Writing Core Knowledge is designed to introduce medical communicators to a career in regulatory writing for drug development. 

This program is organized into 3 content areas - the drug development process, core knowledge and skills, and analytical skills. In total, the 10 activities provide a comprehensive overview of the knowledge and skills you need to succeed as a regulatory writer. After completing the certificate program, participants should be able to 

• Discuss general research ethics
• Discuss transparency and disclosure requirements
• Describe basic statistical concepts in clinical trials
• Interpret and write about data from clinical trials
• Describe key documents that regulatory writers typically contribute to in the lifecycle of a drug
• Define key regulatory requirements for drug development in the US and other countries, particularly those related to clinical development