Valeria Maria Misani

Biography

  Independent Regulatory affairs consultant I have over 25 years of experience within the pharmaceutical industry in the areas of production - quality control of medicinal products and regulatory affairs. I am currently a consultant in Regulatory Affairs for several pharmaceutical companies. I establish and implement high-level regulatory strategies for the medicinal products in line with both the local and international strategies. I provide information and advices at all stages of the development of new products, ensuring a proactive communication of specific local and EU regulatory and pharmacovigilance environment. I work to get registrations of medicinal products, in short timelines, in accordance with National procedure and in support of MRP and DC procedures. I work on the maintenance of the approved products and, in particular, preparing, submitting to the authorities and following these activities: • Preparation of applications for obtaining Marketing Authorizations (MAs); • Pricing of products; • Drafting and submission of Variations type IA, IB and II, under the laws/guidelines in force; • Renewals of MAs; • Gap analysis – CMC compliance; • Reformatting of the Technical-Pharmaceutical dossiers in CTD, e-CTD; • Updating SPC, PIL and labels according to the QRD template into force, for readability test; • Artworks; • Communication and relationship with AIFA and Ministry of Health or other EU Agencies; • Preparation of SOP, Operating Instructions and templates for the RA applications; • Training of staff in regulatory affairs. Regarding the activity of Business Development (licencing in - out), I proactively carry out • Due Diligences on the Dossiers for business growth and support the companies on the strategies. Regarding the Scientific Service, I follow companies on their activities under the law-guidelines in force and I follow the team in the advertising matters. I am a certified Qualified Person at AIFA.

Research Interest

Regulatory Affairs