This 10-week self-study course has been specifically designed for new entrants to pharmaceutical regulatory affairs wanting a complete overview of the issues and systems affecting the approval of their products.

• Discover the origins and purposes of pharmaceutical regulation, and the principle 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 both 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)
• Find the approach to gaining marketing authorisation that works for your markets – and make sure you meet the required safety standards.
• Keep abreast of current standards and relevant issues (such as regulation of orphan drugs and problems surrounding parallel trade) and prepare for changes, to ensure continued compliance across your company.
• Pick up advertising and marketing best-practices that could ensure the success of your product.

Follow PTI on twitter:
@PTI_Courses

http://twitter.com/#!/PTI_Courses