Audio Conference

The EU Paediatric Rule: What It Means for Pharma Dr. Ulrich Granzer Granzer Regulatory Consulting & Services Recording - US$199

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The European Union's pharmaceutical legislation has an important addendum, the legislation on paediatric drugs. It requires all applicants submitting a marketing authorisation application for a new molecular entity to provide a paediatric investigation plan (PIP). This mandatory PIP will be evaluated by the paediatric committee of the EMEA. The objective of the new legislation is to develop "better medicines for children" within the EU. There are obvious consequences for the pharmaceutical entrepreneur. The PIP must be made available during submission and paediatric trials will have to be performed. In this audio conference we will look at various aspects of the new legislation and how it will affect drug manufacturers.

This audio conference will address:

• When paediatric investigation plan (PIP) is required
• Possible consequences on review times
• Can it delay submissions?
• What happens if the paediatric trials are negative
• The 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
• Drug development
• Legal departments
• Senior management
• Business development
  

This audio conference is classified as General Interest.

Purchase Options

• Purchase a recording of this event US$199