Boston Training Week
Some of our most popular training courses are being offered in Boston this August. Enroll now to secure your spot before classes are full!
Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy. This comprehensive course employs a blend of real-world examples, interactive lectures, workshops, and online pre-course modules.
Arm yourself with the tools to write and assemble CMC sections of regulatory submissions, prepare for and orchestrate CMC meetings with FDA, and provide a clear understanding on how to avoid noncompliance.
This introductory course will help you understand how companies structure their efforts and utilize their resources to improve the odds of successful development and minimize the risks associated with shepherding a new drug candidate through the development process.
In this comprehensive training course, you will learn contemporary principles, regulatory expectations, and practical approaches to drug safety and pharmacovigilance in key regulatory jurisdictions, with a focus on the US and EU.
Leave this course with an understanding of how elements of the Pharmacovigilance and Quality Management Systems fit together to achieve regulatory compliance.
Travel Once and Double Your Learning
Attend two of DIA’s most popular safety and pharmacovigilance courses back-to-back in Boston! Register for the Drug Safety and Pharmacovigilance Across the Product Lifecycle and The Pharmacovigilance Quality Management System training courses today!
If you are interested in registering a group or organizing a customized training course at your own location, please contact Training@DIAglobal.org.