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

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

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