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Author Archives: Sam Welgemoed
Faculty conversation: TQT study – this is the end!
Recently, the FDA, other regulatory bodies, and pharmaceutical companies have been exploring options to replace TQTs with preclinical testing or with data collected during standard Phase I trials. Join colleagues from the FPM and also the British Pharmacological Society and … Continue reading
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EUFEMED Joint Conference of European Human Pharmacological Societies 2015
The European Federation for Exploratory Medicines Development (EUFEMED), a newly formed Federation of Early Phase associations; Club Phase 1 (France), BAPU (Belgium), AGAH (Germany) and AHPPI (UK), proudly hosted the 3rd Joint Conference of European Human Pharmacological Societies, which took … Continue reading
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EUFEMED & EUCROF submission on publication of Category 1 clinical trial results
Following the recent stakeholder meeting on the transparency addendum for the EU portal and EU database, which took place at the EMA on 01 June 2015, the Exploratory Medicines Development (EUFEMED) and the European CRO Federation (EUCROF) have made a … Continue reading
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EUFEMED consultation response to EMA Draft proposal for an addendum, on transparency, to the ‘functional specifications for the European Union (EU) portal and EU database to be audited’
The EMA recently launched a public consultation on their “Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited – EMA/42176/2014”, for proposals and options on the application of … Continue reading
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EUFEMED – Joint Conference of European Human Pharmacological Societies 2015
Hosted by the Belgian Association of Phase I Units (BAPU) and organised in collaboration with the European early clinical drug development associations from France (Club Phase 1), Germany (AGAH) and the United Kingdom (AHPPI), EUFEMED welcomes you to attend the … Continue reading
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