Regulatory Affairs & Compliance

Our courses on regulatory affairs and compliance cover the main submissions required for the development and marketing of medicinal products in Europe and the USA.

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These include applications for approval to conduct clinical trials, to be granted orphan product status, to market new or generic products, and to make post-marketing changes.

Whether they are introductory courses for entry-level regulatory affairs and for support staff, or they are more advanced courses for more experienced staff, they provide both a training and a reference tool that is continually updated in response to developments in regulatory requirements.

Please select any of the below courses to look at detailed outlines of the modules, indicating what can be learnt and for whom it is most applicable.

Regulatory Affairs & Compliance courses

Our courses on regulatory affairs and compliance cover the main submissions required for the development and marketing of medicinal products in Europe and the USA. These include applications for approval to conduct clinical trials, to be granted orphan product status, to market new or generic products, and to make post-marketing changes. Whether they are introductory courses for entry-level regulatory affairs and for support staff, or they are more advanced courses for more experienced staff, they provide both a training and a reference tool that is continually updated in response to developments in regulatory requirements.

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About Zenosis

Benefits of Zenosis

Essentials

Regulatory Affairs & Compliance

Clinical Trials

Good Manufacturing Practice

Drug Safety and Pharmacovigilance

Pharmacokinetics and Pharmacodynamics

Information and Communication Technology

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