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Regulatory personal business is a relatively new profession which developed from the desire of governments to protect common health by dominant the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
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How big should the margins be on a thesis?
2.2.1 A4 is the recommended thesis size. 2.2.2 The top, bottom and right side margins should be 25 mm, whereas the left side margin should be 35 mm for both textual and non-textual (e.g., figures, tables) pages.
Why are regulatory and Clinical Affairs careers important?
Regulatory affairs and clinical development are parts of the biotech pipeline that come after discovery research and before the product can be used out in the world (which is most of that pipeline!) In this way, scientists in regulatory and clinical careers are important gateways.
Which is responsible for authorisation of a clinical trial?
Very often, our regulatory department will only do the application for authorisation of a clinical trial to the EC, whereas in most cases the submission of the relevant documents to BfArM remains in the responsibility of the sponsor.
Last Update: Oct 2021
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