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Top advisor warns against arrogance towards EU

Tone down the arrogance towards EU’s regulatory authorities, when it comes to approval of new drugs and medical equipment. It could backfire, says Steffen Thirstrup, who knows the system better than most people. He also warns against common errors that he sometimes sees from inexperienced companies.

Biotech and pharmaceutical companies should shelve the arrogance when applying for approval of new drugs or seeking the all clear to go ahead with clinical testing in the EU. EU’s medicines authorities, EMA, take offence to being looked down upon as a less important agency than the American FDA.

That is the advice offered by top advisor for the pharma and medtech industries, Steffen Thirstrup, advisory board member, NDA Regulatory Services, and former head of medicines approvals in Denmark.

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