This workshop will provide strategic advice on how to file applications for the marketing authorizations in the European Union for staff involved in International Regulatory Affairs.
Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.
KEY TOPICS
鈥uropean Union
鈥entralized Procedures
鈥ecentralized Procedure
鈥utual Recognition Procedure
鈥ational Procedure
鈥ey Issues to Consider for Business
鈥辫辫辞谤迟耻苍颈迟颈别蝉
鈥egulatory Strategy
鈥egal Status of Products and Switching from Rx to OTC
鈥edical Devices Legislation
鈥linical Trial Directive.
Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.
KEY TOPICS
鈥uropean Union
鈥entralized Procedures
鈥ecentralized Procedure
鈥utual Recognition Procedure
鈥ational Procedure
鈥ey Issues to Consider for Business
鈥辫辫辞谤迟耻苍颈迟颈别蝉
鈥egulatory Strategy
鈥egal Status of Products and Switching from Rx to OTC
鈥edical Devices Legislation
鈥linical Trial Directive.
