PRICING AND DISCOUNTS
VAT is added for UK purchases at checkout
Purchase | Discount |
---|---|
1 course | 0% |
2 courses | 5% |
3 courses | 10% |
4 courses | 15% |
5 courses | 20% |
more(each) | 25% |
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. 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.
Essentials of EU and US Regulatory Affairs for Human Medicinal Products
Rated 0 out of 5
(0) £99.00 £79.00 exc. VAT
Preparing Submissions in the Common Technical Document (CTD) Format
Rated 0 out of 5
(0) £74.00 exc. VAT
The New Drug Application (NDA) for Marketing Approval in the USA
Rated 0 out of 5
(0) £129.00 £89.00 exc. VAT
Registration of Medicinal Products Based on Monoclonal Antibodies
Rated 0 out of 5
(0) £74.00 £59.00 exc. VAT
The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA
Rated 0 out of 5
(0) £25.00 exc. VAT
How to Gain and Maintain Approval for Clinical Research Under the EU Clinical Trials Directive
Rated 0 out of 5
(0) £149.00 £99.00 exc. VAT
The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials
Rated 0 out of 5
(0) £149.00 £99.00 exc. VAT
How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation
Rated 0 out of 5
(0) £95.00 £75.00 exc. VAT
How to Conduct Clinical Research Under the EU Clinical Trials Regulation
Rated 0 out of 5
(0) £49.00 £39.00 exc. VAT
Clinical Trial Safety Reporting Requirements in the EU and USA
Rated 0 out of 5
(0) £95.00 £75.00 exc. VAT
The Biologics License Application (BLA) for Marketing Approval in the USA
Rated 0 out of 5
(0) £99.00 £89.00 exc. VAT
The 505(b)(2) Application for Marketing Approval in the USA
Rated 0 out of 5
(0) £59.00 £39.00 exc. VAT