Asphalion, member of CataloniaBio, is organizing a seminar which will address the main aspects of the regulatory Food and Drug Administration (FDA) as well as the recent changes that are taking place in the United States and their present and future consequences. The seminar will also explain FDA success story and will discuss in detail current issues such as the Orphan Drug Designation (ODD), US generic products, key to the success of pre-approval FDA inspection, post-approval activities, and other submissions.
Asphalion is an international regulatory affairs company with over 70 professionals working in the pharmaceutical industry and biotechnology and medical devices companies. Its services range from early stages of regulatory registration of products in addition to marketing and post-marketing.
With the collaboration of Palobiofarma and TDV Experts.
Registration (10% discount for members of CataloniaBio)
Venue: Hotel Condes · Passeig de Gràcia 73 · Barcelona
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