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.

This audio conference covers:

• How the centralized procedure functions
• What needs to be taken into consideration after receiving the List of Outstanding Issues
• Issues around the paediatric investigation plan
• What a Letter of Undertaking is and how best to handle it
• When a scientific advisory group (SAG) becomes 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 on all aspects of drug development and regulatory affairs. Dr. Granzer has extensive industry experience, having held senior positions at Glaxo, BASF Pharma - Knoll, and Bayer. He has been involved in the development and registration of products targeting HIV, asthma, pain, chemotherapy induced emesis, several biological compounds directed against the sequelae of stroke, septic shock, and rheumatoid arthritis.

Dr. Granzer also played a significant role in development of the first fully human anti TNF antibody, now marketed as Humira. He has worked on more than 100 NME's and MNE submissions in several major indications such as HIV, rheumatoid arthritis, asthma, pain, cancer, stroke, and tissue regeneration with small molecules and biologicals.

Who should attend?

• Regulatory Affairs Managers
• General Management
• Legal Departments
• Managers/Heads of Business Development
• Senior Management of Biotech Companies