Industry Update on Centralized Procedure in the EU

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 the paediatric regulation has created the necessity for a more extensive planning process and in particular, how line extensions of existing products are concerned.

Industry Update on Centralized Procedure in the EU is being presented by Dr. Ulrich Granzer, with Granzer Regulatory Consulting and airs on Thursday, April 30, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

Using Mutual Recognition and Decentralized Procedure for EU Drug Registrations

Is your company preparing to market a new pharmaceutical product in Europe? Pharma companies intending to bring new products to market in the EU must follow one of three distinct processes – Centralized Procedure, Decentralized Procedure or Mutual Recognition. Previous presentations by Dr. Granzer have dealt with Centralized Procedure. This presentation focuses on the other two methods, Decentralized Procedure and Mutual Recogniton.

These procedures can be used for certain new drugs, generics and herbal medicinal products. In the case of the MRP there must be a national marketing authorization in place, whereas DCP can be used to seek approvals where none currently exist. This presentation provides an overview of DCP and MRP, including which procedure is appropriate for which products, the expected timeframe for each, and the kinds of submissions expected.

Using Mutual Recognition and Decentralized Procedure for EU Drug Registrations is presented by Dr. Ulrich Granzer, of Granzer Regulatory Consulting on 2008-10-02. You can register at our site www.fxconferences.com

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.

An Overview of EMEA & Centralized Procedure

European legislation governing pharmaceutical regulations has undergone a major revision in recent years. It began with an initiative of the EU Commission in 1999, and culminated in the implementation of a new regulation concerning the structure and the name of the EMEA, the European Medicines Agency.

These sweeping changes also affected the centralised procedure, with major revisions regarding fast track, conditional approval and approval under exceptional circumstances. Furthermore, the basic EU pharma legislation, Directive 2001/83, has been changed to adapt to the needs of the enlarged European Union including 25 full members plus Iceland, Norway, and Liechtenstein.

In this audio conference, Dr. Granzer will discuss the changes impacting pharmaceuticals in the EU, and how best to navigate the maze in getting your products to market.

This audio conference is presented by Dr. Ulrich Granzer, of Granzer Regulatory Consulting. For more details, please visit our site 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.