The majority of all pharmaceutical company revenues now face generic competition. This represents an unprecedented growth in the generics market. With more and more patents expiring since 2006, this global expansion looks set to continue.
Bringing a generic drug to market can be fraught with regulatory challenges and compliance issues. This course will allow the participants to:
• Create effective regulatory affairs strategies for post-patent expiry
• Understand EU and US generic requirements
• Maximise generic market-share potential
• Devise best strategy for approval in the EU and US
Price: Book before the 29th April 2014: £1,395.00 + (VAT @ 20.00%) = £1,674.00, Book after the 29th April 2014: £1,495.00 + (VAT @ 20.00%) = £1,794.00