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January 16, 2019

Having a teleconference or a face-to-face meeting with Regulatory Affairs Authorities is business-as-usual in our Regulatory Affairs world. Still, I often get surprised how many people underestimate an overall process of preparation, conduct and closing of interactions with Regulatory Affairs Authorities.

There are som...

January 30, 2018

No matter if you are a C-suite executive, a regulatory expert with many years of experience in industry or a complete newbie, tough regulatory situations are going to happen and can impact your business considerably.

You will get tough questions from regulatory agencies, discover gaps in your regulatory strategy and ma...

October 25, 2017

Regulatory affairs professionals must be excellent project managers. It’s not enough to simply copy/paste regulatory timelines or wording from legislation, check the available documentation from your previous projects and slightly adapt.  There are many potential pitfalls that make regulatory job unpredictable and you...

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