This report will enable you to implement a regulatory strategy that will guide your product from development to launch, in both the EU and US.
Discover the origins and purposes of pharmaceutical regulation, and the principal regulatory bodies. Appreciate how they affect your role as a regulatory affairs professional
Know how to ensure your pre-clinical and clinical studies comply with key EU and US regulations, including GLP, GCP, the EU Clinical Trials Directive and FDA requirements
Learn the fundamental procedures, issues and initiatives (including the FDA Critical Path) that will have an impact on your regulatory strategy
Gain awareness of other procedures so you can manage the approval process for a range of product types (including biosimilars, generics and variations).
Pharmaceutical Regulatory Affairs in the EU & US market research report provides a detail review of the sector with 230 pages.