B22. Unapproved medicines and PV (Clinical and SAS)

Tracks
Pharmacovigilance
Thursday, June 13, 2024
2:45 PM - 3:45 PM
Parkside 1

Chair & Speakers

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Mr Carl Bufe
Director
PharmOut

Chair: Unapproved medicines and PV (Clinical and SAS)

Biography

Carl Bufe, Director of Pharmacovigilance for the Asia Pacific region at PharmOut, brings over 23 years of expertise in pharmacovigilance, regulatory affairs, and pharmacy. He has honed his patient safety, leadership, systems architecture, and project management skills with degrees and training in Pharmacy, Commerce Risk Management, Quality Systems, Regulatory Affairs and Artificial Intelligence. A recognised leader and speaker, he has significantly advanced drug safety and medicine management, ensuring strict compliance with regulatory standards. Passionate about AI's potential in healthcare, Carl is committed to ethically integrating AI to improve patient outcomes and optimise services.
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Corrin Shepherd
Cluster Safety Lead
Pfizer Australia

Navigating the Regulatory Maze: Ensuring Safe and Ethical Access to Unapproved Medications Through Robust Pharmacovigilance

Biography

Corrin trained as a pharmacist holding a Bachelor of Pharmacy degree from the University of Queensland. During her studies, pre-registration and early pharmacist career, she was exposed to various aspects of community and hospital pharmacy, including rural pharmacy, drug information centers and sterile medicines preparation. During her time in the industry, she has held a variety of roles in medical information, compliance, regulatory and medical affairs before returning to pharmacovigilance with Pfizer in 2018. As a cluster lead managing a number of full-service Drug Safety departments in Australia and south Asia, she has the opportunity to see that crucial role pharmacovigilance plays in not just the reactive receipt of safety information but using this information to proactively detect changes to risk-benefit balance, ensuring that up to date information is available to prescribers and patients. She is committed to advancing pharmacovigilance initiatives to enhance patient care, outcomes and improve patient’s lives.
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Mr Stanly Paul
Principal Pharmacovigilance Specialist (Program Oversight & Project Leadership)
ProPharma

Navigating the Regulatory Maze: Ensuring Safe and Ethical Access to Unapproved Medications Through Robust Pharmacovigilance

Biography

Stanly Paul is the Principal Pharmacovigilance Specialist (Safety and PV Program Leadership), in a Research Consulting organisation, ProPharma. He has worked for 12 years in Clinical Safety and Pharmacovigilance. Stanly Paul had worked in leading Contract Research organisations, IQVIA and Labcorp Drug Development (Fortrea) involved in many pharmacovigilance audits and inspections of major Regulatory agencies of USFDA, EMA, MHRA, PMDA, TGA and many. Stanly Paul had done in Masters in Pharmaceutical Biotechnology, University of Greenwich, Kent, United Kingdom and Bachelors in the TamilNadu Dr.MGR Medical University, Chennai, India Stanly Paul is a certified Project Management Professional (PMI USA) and volunteering as Associate Director for PMI Western Australia chapter for key portfolios.
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