President of the North American Chapter of the international society of pharmaco

ISoP annual meeting in Montreal 1-5 October 2024.Pharmacovigilance Global Perspectives in the Digital Age and Advanced Therapeutics.

Sanofi Canada

AI impact on PV & Drug Safety

How artificial intelligence ca facilitate organizational design, create a continued learning mindset and standardize data to ease the workload on your team

Speaker: Using Artificial Intelligence to optimize Pharmacovigilance workload

Social Media and Signal detection: how it has or has not worked and potential ways to implement it in your company.

Using Artificial Intelligence to optimize workload : How AI can facilitate organizational design , create a continued learning mindset , and standardize data to ease the workload on your team

International regulation - Understanding the current regulatory landscape

▪ Attend prospective client meetings via skype to gather requirements and network with clients.▪ Address client concerns, following up with responses and proposing solutions.▪ Organise and managing client meetings, addenda’s and presentations.▪ Identify solutions and work around for clients.▪ Prepare of comprehensive proposals tailored to client’s needs

• Ensure compliance with regulations and hospital pharmacy good practices. • Plan and monitor regulatory controls • Participate in management reviews.• Write, update and validate the documents of the quality management system. • Record unwanted events and implement and monitor corrective actions.• Preparation and follow up of inspections. • Participate in quality audits and the certification procedure. • Follow and monitor the subcontracting activities: feasibility study, convention draft.

Centre Régional de Pharmacovigilance (Réseau ANSM)• Provide safety information to healthcare professionals according to the approved product labeling and internal procedures.• Data entry processing and review of product complaint cases with MedDRA coding.• Detect and assess adverse drug reactions: signal detection and causality assessment (individual case safety reports and case series)• Review scientific literature and bibliographic sources.

- Tests of safety/harmlessness- Tests of abnormal toxicity- Tests of local tolerance (cutaneous and ocular)- Methods: DRAIZE, HET-CAM Test- Research of pyrogens (Endotoxins) substances in vivo, in vitro (LAL test)- Methods of studies and screening of psychotropic, sedative, analgesic and anti-inflammatory substances- Dosage and identification: TLC, GCP, HPLC, LC MS / MS, Dissolutest, Tablets and suppositories disintegration, tablets friability.- Microbiological testing of non-sterile products.- Sterility testing of pharmaceutical products- Biological Titration of the activity of FSH by testing increases of ovarian weight in rats (Method of STEELMAN and POHLEY)