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Review the CMC sections of regulatory submissions, the FDA inspection process, and how to avoid or minimize 483s (noncompliance) with this on-demand course.
| Member Price | Non-Member Price | |||
|---|---|---|---|---|
| Virtual price: | $1,800.00 | $2,125.00 |
Online
Complete this On-Demand Training Course to learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.
| Member Price | Non-Member Price | |||
|---|---|---|---|---|
| Virtual price: | $3,545.00 | $3,870.00 |
Online
Explore FDA's approach to regulation of combination products, the processes to streamline development of single entity, and aligning requirements between drugs and devices.
| Member Price | Non-Member Price | |||
|---|---|---|---|---|
| Virtual price: | $750.00 | $1,075.00 |
Online
Discover the essential principles, regulatory insights, and compliance strategies for medical devices and combination products in this comprehensive on-demand training course.
| Member Price | Non-Member Price | |||
|---|---|---|---|---|
| Virtual price: | $750.00 | $1,075.00 |
Online
Gain a better understanding of the global regulatory landscape for companion diagnostics, from key terminology and IVD classifications to the requirements guiding clinical studies and commercial products in the US and EU.
| Member Price | Non-Member Price | |||
|---|---|---|---|---|
| Virtual price: | $750.00 | $1,075.00 |