Management team

 Emma Blasi

Emma Blasi

Regulatory Affairs Manager

Emma Blasi is an expert Regulatory Affairs professional with more than 12 years’ industry experience in the biopharmaceutical field. She has specialized in the regulatory strategy and drug development of innovative medicinal products, including cell and gene therapy products, genetically modified organisms, orphan drugs and new chemical entities. Emma has a proven track record of leading successful meetings with Regulatory Agencies, including the EMA, FDA and national health authorities in the EU, to discuss the development of new investigational medicinal products.

She joined VCN Biosciences in 2011 as the Regulatory Affairs Manager. With her solid knowledge of global regulatory guidelines and legislation, she designs roadmaps for the Company’s pipeline covering the quality, non-clinical and clinical requirements from discovery to late-phase clinical development. She has an extensive hands-on experience in authoring technical regulatory documentation submitted to the authorities, including IMPDs, US INDs, IBs and benefit-risk balance assessments to support the authorization of clinical trials; Drug Safety Update Reports; Orphan Drug Designation applications and annual reports; briefing documents for regulatory meetings; and technical scientific information to request the use of GMOs in clinical trials. Emma acts as the liaison with Agencies and Ethics Committees, as well as with the Ministry of Environment and National Biosafety Committee, the Competent Authorities for biosafety matters. She holds a BS in Chemistry with a MSc in Organic Chemistry from University of Barcelona.