logo
logo
Mobile Header

PRA2008/2011 Regulatory Submissions and Preclinical – Drugs

This course provides in depth knowledge and hands-on work with various types of regulatory submissions. The completion and applications of regulatory submissions such as CTA, NDS/A, ANDS/A, and CTD are discussed in details. There is an in-depth discussion of the regulatory review process. Strategies on how to have a successful submission is discussed in details.

This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry, in Regulatory Affairs Departments.

Preclinical – Drugs

The course objective is the learn about the requirements for Non-clinical studies in support of producing regulatory filings to proceed to human clinical trials. The documentation and study requirements will be reviewed in the context of global submission in the CTD format.

Online Education Registration CAD$650 +HST

PRA2008/2011 Regulatory Submissions and Preclinical – Drugs

Interested in AAPS? Please fill out this form to request more information!

I consent to be contacted by Academy of Applied Pharmaceutical Sciences and I understand that I can opt-out later

Connect with AAPS

Join our live, interactive virtual classrooms today!Learn more
+