Industry Update on Centralized Procedure in the EU

is being presented by Dr. Ulrich Granzer, Granzer Regulatory Consulting and airs on Thursday, January 20th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com

The revised EU pharma legislation has seen some major changes since coming into force, changes that have now been implemented and, more importantly, interpreted. New and additional guidelines have been issued, a system of scientific advisory groups (SAG) has been established, and the procedure to obtain a marketing authorization is being performed in a more stringent way.

In this audio conference we discuss how centralised procedure works, important points to consider, and how the paediatric regulation has created the necessity for a more extensive planning process – and in particular, how line extensions of existing products are concerned.

Protecting Data Under Current EU Pharma Legslation

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.

Industry Update: The EU Paediatric Rule

The European Union's pharmaceutical legislation has an important addendum, the legislation on paediatric drugs. It requires all applicants submitting a marketing authorisation application for a new molecular entity to provide a paediatric investigation plan (PIP). This mandatory PIP will be evaluated by the paediatric committee of the EMEA. The objective of the new legislation is to develop "better medicines for children" within the EU. There are obvious consequences for the pharmaceutical industry, as the PIP must be made available during submission and paediatric trials will have to be performed.

In this audio conference we will provide the latest information on various aspects of the new legislation and how it is affecting drug manufacturers.

This audio conference is presented by Ulrich Granzer of Granzer Regulatory Consulting. To learn more, visit www.fxconferences.com.