Audio conference highlights
The European Union’s paediatric regulation requires all applicants submitting a marketing authorization application for a new molecular entity to also provide a paediatric investigation plan (PIP). The objective of the new legislation is to develop "better medicines for children" within the EU. This mandatory PIP is then evaluated by the Paediatric Committee of the EMEA. There are obvious consequences for the pharmaceutical industry, as the PIP must be made available during submission, and paediatric trials will have to be performed.
In this audio conference we provide the latest information on various aspects of the legislation and how it is affecting drug manufacturers, including real-life experiences to date and lessons learned from those who have been through the process.
This audio conference covers:
- When a paediatric investigation plan (PIP) is required
- Possible consequences on review times
- What happens if the paediatric trials are negative
- Implications for data protection
- Can it delay submissions?
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
- Clinical Development
- Legal Counsel
- Senior Management
- Business Development