Consultancy in Clinical Research and Medical Affairs. I have already implemented Expanded Access Programs and/or Compassionate Use Programs in many companies in different therapeutic areas, such as Neurology, Oncology and Ophthalmology. I have more than 20 years of professional experience in pharmaceutical industries and CROs, in the following areas: clinical operations (CRA, PM, Line Manager, Clinical Trial Liaison), regulatory affairs, contracts (with sites and vendors), payments, importation/exportation, oversight of studies outsourced to CROs, Start-Up, identification of new sites/ feasibilities, biddings, vendors’ validation, training & quality, medical affairs (compassionate use program, expanded access program). I am the owner of a website with information about clinical research for ordinary people: www.e-supere.com.br, only in Portuguese - or www.facebook.com/e.supere I also have experience in Latin America countries (Mexico, Colombia, Peru, Ecuador, in addition to Brazil), either in Regulatory Affairs for Clinical Research or Clinical Operations. We are now providing regulatory and monitoring services for Clinical Research in Brazil. As a registered company at the MoH, we can represent sponsors that are not based in Brazil to submit studies to ANVISA (Brazilian MoH) and provide the clinical trial insurance on their behalf.