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.

Related content:

Human medicines highlights - Issue 46 - November 2012

The November 2012 issue of the European Medicines Agency's newsletter 'Human medicines highlights' is now available.

All issues of the newsletter are available on the Agency's website.

Related content:

Can adaptive licensing bridge the gap between regulatory and HTA evidentiary standards?

eichler-2.jpg

The prospect of a new model for drug approval based on ‘acknowledged uncertainty’ provided for a lively debate at the European Medicines Agency Review of the Year and Outlook for 2013, an annual meeting organised with TOPRA. The concept of adaptive licensing is not revolutionary, but rather a natural step in the evolution of drug approval, explained the EMA’s Senior Medical Officer, Hans-Georg Eichler. Nonetheless, not all parties were in agreement.

Related content:

Sir Michael Rawlins: the profession needs to adapt and respond

sir-michael-expressive.jpg
Sir Michael Rawlins, chair of NICE, addressed a packed audience of regulatory affairs professionals in the inaugural TOPRA Annual Lecture.

Speaking ahead of this year's TOPRA Awards for Excellence in Regulatory Affairs at London's Radisson Blu Portman Square on 28 November, Sir Michael asked the question ’Is the regulatory profession fit for the future?’.

Related content:

Regulatory Affairs profession celebrates its achievements in style

Awards Dinner table

The winners of this year's TOPRA Awards for Excellence in Regulatory Affairs were announced at a gala celebration at London's Radisson Blu Portman Square on 28 November.

Richard Barker, OBE, who was recently named as one of the 50 most influential people in UK healthcare, hosted the event which attracted RA professionals from across Europe, the US and India and many healthcare sectors.

Related content: