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  • Thanks Ginger, I really appreciate your time and support! Regards, ------------------------------ Bhupinder Singh San Jose CA United States ------------------------------

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    RE: RAC Preparation

    Arvila, You've highlighted the problem with multiple-choice exams - they're more a test of deduction abilities than of knowledge and understanding. ------------------------------ Steve Binysh Acta Pharma Services Ltd RUISLIP United Kingdom ------------------------------

  • ​David beat me to it. Back when I was new at this, I agreed to prepare and submit 510(k)s for a non-US firm who wanted to market their product in the US. I had them all written, copies made, ready to go when I got a phone call. They had found an exclusive licensed distributor who had agreed to submit the 510(k) and act as if the non-US firm was a contract ...

Rainer Voelksen, FRAPS, Talks Volunteering and European Advisory Committee

"Regulatory professionals need to hear the voices of those working in other countries. Just helping others to get used to hearing other languages is important, and you can be a cultural representative at the table in any stage of your career. The regulatory industry is increasingly global, but all regulators work differently. We must all work harder to become comfortable sharing information in an international space so that the industry can successfully continue to develop."

Rainer Voelksen, FRAPS

 

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