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Description
This course provides the basic concepts of pharmacovigilance and materiovigilance, with a focus on the regulatory and practical aspects of postmarket safety science of drugs, biologics, and medical devices. It introduces Individual Case Safety Report (ICSR) generation and processing and explains adverse drug reaction (ADR) reporting. The course describes key safety databases, pharmacovigilance software, aggregate reports, and risk management strategies. Importantly, the course features modules on both U.S. and global pharmacovigilance practices and regulations. The course concludes with two modules on materiovigilance, or the postmarket surveillance and reporting for medical devices, covering both U.S. and international practices and regulations.
Audience
Biotechnology Companies, Contract Research Organizations (CROs), Medical Device Manufacturers, Pharmaceutical Manufacturers, Principal Investigators (PIs), Regulatory Affairs Professionals, Sponsors, Students
Meet the Author
Akshita Srivastava, MSc – DDReg Pharma Pvt. Ltd.
Akshita is an assistant manager in business development at DDReg Pharma Pvt. Ltd. – a globally renowned regulatory and pharmacovigilance service provider. She has previously been associated with organizations like Weill Cornell Medicine Qatar and PwC UK. She holds an MSc. in Pharmacology from Kings College London.
