Leading Regulatory Bodies, Pharmaceutical and Biotech Companies Address the Challenges Facing Today

July 7, 2010 - PRLog -- With the focus on cost control more important than ever, phase I clinical trials are becoming an increasingly crucial cog in the drug development process as the bid to save time and money has spurred innovation in trial design and processes at all levels.

Hear from three key regulatory experts, including:

•   JW McBlane, Preclinical Assessor, Clinical Trials Unit, MHRA
•   Dr Christen Steffen, Head of Preclinical Unit, BfArM
•   Dr Walter Janssens, Senior Preclinical Assessor, Preauthorisation, Coordinator Early Phase Development, Federal Agency for Medicines and Health Products, Belgium

As well as Pharma & Biotech experts, including:

•   Dr Paul Passier, Global Clinical Pharmacology Lead, Pain, Astellas
•   Birgitte Søgaard, Divisional Director – Clinical Pharmacology & Translational Medicine, H. Lundbeck A/S
•   Michael- Friedrich Boettcher, Global Clinical Pharmacology Project Leader, Bayer Schering Pharma AG
•   Jurgen Moll, R&D Oncology, Cell Biology, Nerviano Medical Sciences
•   Dr James Dow, Director of Clinical Pharmacology and DMPK, (OSI) Prosidion


As they discuss the following important topics:

1.   The most effective trial design methodologies to ensure rapid submission and approval timelines, with innovative solutions to combining phase I and IIa from NicOx and Novartis
2.   Utilise preclinical data analysis: including PK/PD modelling, metabolomics and translational methods to improve FIM predictions and avoid errors. Share best practice with discussions and case studies from UCB, Lundbeck, Servier and Johnson & Johnson
3.   Increase productivity and minimise costs through implementing patient-based phase I trials: enhancing the selection and recruitment processes and overcoming operational constraints
4.   Streamline the outsourcing process and establishing an effective working relationships with CROs: case study and discussion from Actelion

Innovation in Phase 1 Clinical Development will also feature a unique opportunity to get up to date on the latest regulations for submission criteria, application processes and exploratory trials with case studies and a joint workshop from MHRA, BfArM and FAGGS

For more information on the Phase 1 Conference you can review the agenda at http://www.phase1clinicaldevelopment.com/


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