This workshop examines the post-marketing requirements of licensed healthcare products (including cannabis) as well as the maintenance of the product’s benefit/risk profile throughout the product life cycle. Attendees learn and apply the regulatory aspects of pharmacovigilance systems, including receipt and assessment of case reports, signal detection, and inputs to periodic summary reports. Concepts such as safety information resulting in labeling changes and principles of risk management systems will also be discussed.
• Adverse event intake, triage, and causality assessment
• Sources of adverse events (solicited and unsolicited)
• Elements of an effective pharmacovigilance system
• Comparison between different periodic summary reports (PSUR, PBRER, PADER)
• Signal detection and assessment
• Principles of risk management plans
• Inputs to label changes (confirmed signal, periodic review of core label, product recall)
• Details of Cannabis adverse reaction reporting guide
SPEAKER: Dr. Marissa Fernandez
Dr. Marissa Fernandez is the current pharmacovigilance responsible person and one of the Drug Safety Physicians for a global healthcare company that provides a leading portfolio of critical care, nutrition, renal, hospital, and surgical products (refer to LinkedIn www.linkedin.com/in/marissa-fernandez-aa51768). Marissa is both a pharmacist and a medical doctor by training with over 25 years of comprehensive knowledge and cross-functional experience in Pharmacovigilance, Regulatory Affairs, and Quality Assurance within the pharmaceutical industry. Marissa has held various roles with increasing responsibilities, is recognized for operational excellence, and has successfully led various national inspections and audits. Marissa has a thorough knowledge of pharmacovigilance principles and regulations from Health Canada, ICH guidelines, and the European Medicine Agency’s Good Pharmacovigilance Practices modules. She has also completed her Certified Quality Auditor Certification from the American Society of Quality.
Marissa is concurrently a part-time faculty in the Regulatory Affairs Program and an active member of the Program Advisory Committee of Humber College’s Faculty of Health Sciences and Wellness. Marissa is responsible for courses in Medical Products Safety, Regulatory Legislations and Submissions, Medical Devices, Provincial Formularies, and Reimbursement Policy.
Registration Deadline: 11 Nov 2020
|Student Ticket:||$200.00||— On Sale||Until: 11/11/20 3:15 PM|
|Basic Member Regular:||$445.00||— On Sale||Until: 11/11/20 3:15 PM|
|Pro Ticket Regular:||$395.00||— On Sale||Until: 11/11/20 3:15 PM|