European pharma legislation has seen several major changes come into effect over the past several years. Amongst others, the data protection rules have changed substantially. The data protection period for new approvals is now 8+2+1 years. The orphan protection, a full market exclusivity period, is 10+2 years. And the very recently introduced legislation on paediatric drugs (PUMA and PIP) plays an important role as well. The concept of the "Global Marketing Authorisation" needs consideration for the planning of the effective data protection period.
This presentation helps attendees understand current EU data protection rules and how best to operate within the regulatory framework.
This event is presented by Ulrich Granzer, owner of Granzer Regulatory Consulting & Services. To learn more, please visit www.fxconferences.com.
