TOPRA News

TOPRA’s MSc in Regulatory Affairs now validated by the University of Hertfordshire

TOPRA is pleased to announce that the MSc in Regulatory Affairs is now validated by the University of Hertfordshire.

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Craig McCarthy: recognise excellence in regulatory affairs

craig-mccarthy-photo.jpgHaving been involved in teams for most of my life - in regulatory affairs and the military - I find it good to motivate an individual who’s done an excellent job with well-thought-out personal feedback or a reward.

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Roundtable debate: MEP welcomes dialogue on new legislation

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TOPRA organised a roundtable discussion where regulatory affairs professionals had the opportunity to meet Marina Yannakoudakis, MEP. The event took place on 10 January 2013 at the Royal Society.

Marina is an MEP for the London region in the UK and sits on the ENVI committee, the Environment, Public Health and Food Safety committee within the European Parliament.

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Industry raises some concerns over PRACticalities of pharmacovigilance hearings

The infrastructure for holding public hearings under the EU pharmacovigilance legislation’s Urgent Union Procedure is not yet in place, but industry is nonetheless concerned about how this will work in practice. At TOPRA’s Annual European Medicines Agency Review of the Year and Outlook for 2013, companies pressed EMA officials for more information on the procedure during an update on PRAC (Pharmacovigilance Risk Assessment Committee) activities.

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European Commission focuses on ‘lessons learnt’ from Paediatric Legislation

Stakeholders ranging from industry to clinicians have had an opportunity to voice their opinions on the Paediatric Regulation in the European Commission’s public consultation that ended on 28 November. It was therefore timely that the next day, the ‘Annual European Medicines Agency Review of the Year and Outlook for 2013’, a meeting organised with TOPRA, included an update on this very subject.

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