Audio Conference

Protecting Data Under Current EU Pharma Legslation Dr. Ulrich Granzer Granzer Regulatory Consulting & Services Purchase recording US$199

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European pharma legislation has seen several major changes come into effect over the past two 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 will help attendees understand current EU data protection rules and how best to operate within the regulatory framework.

This audio conference will address:

• The three different stages of data protection
• How the new registration systems work in principle
• What the data protection legislation means
• Why it is important to take these new rules into consideration
• Why orphan drug status might be important
• The paediatric program and its implications for data protection
  

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.

He also played a significant role in development of the first fully human anti-TNF antibody, now marketed as Humira. Dr. Granzer has worked on more than 100 NME's 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?

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

This audio conference is classified as General Interest.

Registration Options

• Purchase a recording of this event US$199