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.

EU Centralized Procedure for Generics

Since its inception in 1995, the centralized procedure has been used for new and biological drugs. Now that the data protection period for the first approvals at EMA is over, generics can be approved in the European Economic Area using the centralized procedure. But does this make sense? What are the alternatives? What is the decision matrix to be used to decide upon the “right procedure”?

This presentation gives answers to these and several more questions on the EMA, the CP and its role in generics approval.

EU Centralized Procedure for Generics is being presented by Dr. Ulrich Granzer, Principal Consultant, Granzer Regulatory Consulting and airs on Tuesday, March 9, 2010. For more details or to register, please visit our site at www.fxconferences.com

Protecting Data Under Current EU Pharma Legislation

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.

Protecting Data Under Current EU Pharma Legislation was presented by Dr. Ulrich Granzer, with Granzer Regulatory Consulting & Services and aired on 2006-12-14. For more details or to download this event, please visit our site at www.fxconferences.com

The EU Perspective on Risk Management

Does your company market its products in Europe, or are you planning to enter the EU market? Have you taken the requisite steps to address risk management? Risk management must be an integral part of global product development and commercialization.

In this audio conference Dr. Blesse will provide a detailed overview of EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use and its legislative background. He will also provide examples of why this new regulation should not be perceived as another threat to industry, and how it offers strategic options.

The EU Perspective on Risk Management was presented by Dr. Stefan Blesse, with Granzer Regulatory Consulting and aired on 2007-07-19. To download this event, or for more details please visit our site at www.fxconferences.com

An Overview of EMEA & Centralized Procedure

Learn about the EMEA, centralized procedure, Directive 2001/83, and how major changes with the EU could affect you.

European legislation, responsible for governing pharmaceutical regulations, has seen major changes in recent years. In 1999, an initiative of the EU Commission culminated in the implementation of a new regulation concerning the structure and name of the European Medicines Agency (EMEA).

Also affected by these sweeping changes was the centralized procedure. Major revisions were invoked concerning fast track, conditional approval and approval under exceptional circumstances. In addition, the basic EU pharma legislation, Directive 2001/83, has been modified 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 discusses the changes impacting pharmaceuticals in the EU and how to navigate the maze to get your products to market.

An Overview of EMEA & Centralized Procedure was presented by Dr. Ulrich Granzer, Granzer Regulatory Consulting and aired on 2008-04-03. For more details or to download this audio 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 was presented by Dr. Ulrich Granzer, Granzer Regulatory Consulting and aired on 2008-10-09. For more details, or to download this conference please visit our site at www.fxconferences.com

The EU Paediatric Rule: Threats, Issues & Lessons Learned

The European Union’s paediatric regulation, which came into force two years ago, requires all applicants submitting a marketing authorization application for a new molecular entity to also provide a paediatric investigation plan (PIP). The objective of the new legislation is to develop "better medicines for children" within the EU. This mandatory PIP is being evaluated by the Paediatric Committee of the EMEA. 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 provide the latest information on various aspects of the legislation and how it is affecting drug manufacturers, including real-life experiences to date and lessons learned from those who have been through the process.

The EU Paediatric Rule: Threats, Issues & Lessons Learned is being presented by Dr. Ulrich Granzer, Owner, Granzer Regulatory Consulting and airs on Thursday, September 10, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

EMEA & Risk Management: What You Need to Know

It is vitally important that pharmaceutical and biotech companies marketing their products in Europe familiarize themselves with what the European Medicines Agency (EMEA) has to say on the subject of risk management. Do you need a risk management plan if you are using centralized procedure? How about decentralized procedure or mutual recognition? Where does risk management go in the dossier? And what sort of risk minimization will be expected?

In this audio conference, EU regulatory expert Dr. Stefan Blesse answers these and more questions about EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use, offering insight and examples as to why it should be considered a strategic opportunity, and not a threat to industry.

EMEA & Risk Management: What You Need to Know is being presented by Dr. Stefan Blesse, Principal Consultant, with Granzer Regulatory Consulting & Services and airs on Thursday, June 4, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

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

The EU Perspective on Risk Management

Does your company market its products in Europe, or are you planning to enter the EU market? Have you taken the requisite steps to address risk management? Risk management must be an integral part of global product development and commercialization.

In this audio conference Dr. Blesse will provide a detailed overview of EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use and its legislative background. He will also provide examples of why this new regulation should not be perceived as another threat to industry, and how it offers strategic options.

The EU Perspective on Risk Management was recorded on 2007-07-19 and will replay on September 16th, 2008 at 11:30 Eastern time. For more information on this audio conference, please visit our site www.fxconferences.com

Risk Management Strategies: US vs. EU

Does your company market its products in Europe, or are you planning to enter the EU market? Have you taken the requisite steps to address risk management? Risk management must be an integral part of global product development and commericalization.

In this audio conference, our speakers will compare and contrast the FDA and European Medicines Agency approaches to risk management. Dr. Stemhagen will focus on the US approache, while Dr. Blesse will provide an overview of EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use. We will also explore the epidemiological methods for post-authorization safety studies, and ways to reduce risk.

This event is co-presented by Annette Stemhagen of United BioSource Corporation and Stefan Blesse of Granzer Regulatory Consulting. To learn more, please visit www.fxconferences.com.