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Audio conference highlights

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.

This audio conference covers:

• Which products can and should go into the DCP or MRP
• How long each procedure takes
• The legal basis for the submission
• What kind of dossiers should be submitted
• Which countries of the EU can be involved

About the speaker:

Ulrich Granzer, PhD is owner of Granzer Regulatory Consulting and Services (www.granzer.biz), providing consulting services to pharma and biotech companies for all aspects of drug development and regulatory affairs. With extensive experience in the pharmaceutical industry, Dr. Granzer has held senior positions at Glaxo, BASF Pharma-Knoll, and Bayer. His involvement in the development and registration of pharmaceuticals has led to successful approval for products targeting HIV, asthma, pain, chemotherapy induced emesis, and several biological compounds directed against the sequelae of stroke, septic shock, and rheumatoid arthritis.

He played a prominent role in development of the first fully human anti-TNF antibody, now marketed as Humira. Dr. Granzer has worked on over 150 NMEs and MNE - submissions in several major indications like HIV, rheumatoid arthritis, asthma, pain, cancer, stroke, tissue regeneration with small molecules and biologicals.

Who should attend?

• Senior Management
• Business Development Managers
• Legal Counsel
• Regulatory Affairs Managers

*This conference is rated General interest.