October 4th 2022 9 am CT |10 am ET | 3 pm BST | 4 pm CET Managing drug, vaccine, and device safety has become increasingly challenging as companies are confronted with adverse event (AE) caseloads rising as much as 30-50% per year. Constrained resources and limited qualified outsourcing options have created the need to streamline the pharmacovigilance/multivigilance process.
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As safety departments seek ways to improve medicinal product safety and protect patients, data science approaches offer significant promise. What’s possible, what's realistic, and what’s the value to the industry and public?
Managing drug, vaccine, and device safety has become increasingly challenging as companies are confronted with adverse event (AE) caseloads rising as much as 30-50% per year. Constrained resources and limited qualified outsourcing options have created the need to streamline the pharmacovigilance/multivigilance process.
A well-designed data science approach can incorporate artificial intelligence and machine learning (AI/ML), rule-based automation, statistical algorithms, and advanced analytics to empower better safety insights, inform human decisions, eliminate tedious and repetitive tasks, improve data quality, and allow organizations to focus their human resources on high-value activities.
With nearly every process in multivigilance having the potential to benefit from data science, what are the keys to successfully deploying it? What are the challenges? What’s been overpromised?
Key Learning Objectives:
Who Should Attend:
Head of PV Digital Case Handling & Quality Control
Denny Lorenz has worked more than two decades in Safety and Pharmacovigilance. He is currently the Head of Pharmacovigilance (Case Handlings & Quality Control, Pharmacovigilance, Single Case Processing) at Bayer in Berlin, Germany. Denny began his career at Bayer in Drug Safety Compliance and has held multiple roles spanning 20 years in pharmacovigilance, including system management, case processing, program delivery and more. Denny holds a master’s degree in Consumer Healthcare from Charité Berlin and a bachelor’s degree in Business Informatics, Commercial Information Technologies from the Berlin School of Economics and Law.
EVP, Scientific Operations
Andy Garrett joined ICON Clinical Research in 2016 and is responsible for the strategic direction and operational execution of ICON’s Global Scientific Operations. Services have included Pharmacovigilance, Regulatory, Medical Imaging; Medical Monitoring; Endpoint Adjudication, Interactive Technologies (IRT), Clinical Supplies Management, Biostatistics and Medical Writing. Previously Andy spent 20 years at IQVIA in various roles including Global Head for the combined Biostatistics, Medical Writing and Regulatory affairs business units, and before that worked for Warner Lambert, American Cyanamid (both now owned by Pfizer) and Parexel in various statistics management roles.
Andy is active professionally. He was previously VP/Honorary Secretary of the Royal Statistical Society, and Chair of its Long Term Strategy Group. He was also Chair and founder of the RSS’s Data Science Section. He was also previously a Board member of the UK’s Administrative Data Research Network. This network promoted and guarded the linkage of administrative data for research and policy purposes, providing assurance to Parliament through the UK Statistics Authority. Subsequently Andy joined the UKSA’s Research Accreditation Panel that oversees the approval of research projects in accordance with the Digital Economy Act 2018. Andy actively supports the UK’s Science Media Centre that provides assistance to the national news media when covering controversial science stories or breaking news.
Andy has a BSc in Economics, an MSc in Medical Statistics and a PhD in Applied Statistics. Andy has worked extensively in the area of rare diseases (including regulatory interactions) and his published work includes papers on the topics of non-inferiority trials, subgroup analysis, data transparency and modelling and simulation. He is based in the UK.
Michael Braun- Boghos
Senior Director Safety Strategy
Oracle Health Sciences
Michael has been working in medicinal product safety for 28 years. He spent 13 years in the European PV headquarters of Fujisawa and Astellas, ultimately leading the Safety Data and Quality Management group. Thereafter he joined Relsys, the developer of the Argus software, and finally came to Oracle Health Sciences with the Relsys acquisition in 2009. As a senior director in the safety strategy team, he helps drive the product roadmap of Oracle Safety One, including Argus, Empirica, and Safety One Intake.
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