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


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.

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Sir Michael Rawlins: the profession needs to adapt and respond

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?’.

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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.

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The first TOPRA Annual Lecture will take place on 28 November, preceding the TOPRA Regulatory Affairs Awards Dinner and Ceremony.

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Samarind RMS to sponsor the 2011 TOPRA Innovation Award

TOPRA is pleased to announce that Samarind, a leading provider of software to the Regulatory Affairs profession, will sponsor the Innovation category of the 2011 Regulatory Affairs Awards.

Lynda Wight, TOPRA’s Executive Director expressed delight that a winner in the 2010 Awards has agreed to support the 2011 event, adding ‘these Awards celebrate the very best in the world of regulatory affairs and with the support of all our sponsors we have added two new categories this year’.

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