Barbara Abissi

Background

About Barbara Abissi

Experience in providing leadership and guidance to direct reports actively managing employee performance and development - Over 10 years of CRO industry experience including International, multicentric studies and biotech sponsors and serving as Subject Matter Expert with extensive knowledge of Brazilian resolutions related to clinical trials - Great experience with rare diseases and Cell & Gene therapy studies (advanced therapy studies)- Extensive knowledge of Brazilian resolutions related to clinical trial and knowledge in GMO/Cell Therapy resolutions over the countries- Experience in reviewing and preparing submissions dossier to local and central Ethics Committees (LECs and CONEP)- Start-up and Maintenance - Experience in reviewing and preparing dossiers to ANVISA (Brazilian Regulatory Authority) including DDCM (Clinical Drug Development Dossier), DEEC (Clinical Trial Applications) and DDCTA (Advanced Therapy Product Clinical Development Dossier)- Experience in preparing Dossier and Import Dossier to CIBio (Internal Biosafety Commission) and CTNBio (National Technical Commission on Biosafety)- Experience with import and export process of investigational products, GMOs and clinical supplies- Extensive experience and knowledge with Plataforma Brasil - Participation in ANVISA (COPEC and GSCTO), CONEP, CTNBio and Sponsors meetings- Participates in project scoping calls, proposal preparation and BDM meetings - Trainee in EU-CTR Regulation - Participation in ABRACRO regulatory meetings and event organization - Good communication