Role of marketing authorization holder in drug safety

Interviewer: Today, I'm interviewing Dr. Raphael Elmadjian Pareschi on preventing risks to patient safety that might otherwise arise in the process of scale-up to industrial-level production. Dr. Pareschi is currently the Head of Drug Safety, Patient Safety Lead, Pharmacovigilance, at the Roche Group, Brazil. He's accepted my invitation to this interview in his personal capacity, and nothing he says should necessarily be taken to represent the views of his employer. Dr. Pareschi, thank you for sparing the time. May we start with some basic questions? One, what are the fundamental responsibilities of a company when manufacturing prescription drugs? Two, what are the biggest challenges a manufacturer faces in meeting its responsibilities, and how are those challenges best met? Three, what is the role of regulators? Four, what are the most common reasons why things go wrong when they do go wrong? Dr. Pareschi. Dr. Pareschi: Thank you, Neil, for the invitation. It's a pleasure talking from Sao Paulo, Brazil, in this interview. I will go with the first question regarding what are the fundamental responsibilities of a company when manufacturing prescription drugs? In terms of the basic pillars of any company that is manufacturing and holding licenses for a drug, they are quality, efficacy, and safety. This is very basic,