Like all facets of the life sciences industry, product quality is transforming in terms of efficiency and importance. Long seen as a records-keeping function, today, future-looking heads of quality are searching for innovations to transform quality management across the product lifecycle.
Quality, regulatory, safety, and commercial compliance are the building blocks that ensure medicines and devices are safe and effective and that companies operate in an ethical manner. However, the shifting global regulatory compliance environment means the impact of these requirements continues to expand, placing an increasing burden on drug and medical device manufacturers.
Changes in industry regulations are regarded as one of the top disruptive business trends facing life sciences organizations, and many leaders view these regulatory changes as a threat to growth. The pressure weighs most heavily on organizational quality compliance. In this webinar series we will discuss the importance of digital transformation and the benefits of implementing a comprehensive eQMS solution comprehensive suite of software solutions purpose-built for life sciences.
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In this rapidly changing global environment, life science companies require true digital transformation and seek comprehensive solutions that provide intelligence-driven insights at the most opportune moment within the end-user workflow. As AI moves from a "nice to have" to a "must have," it is essential to build a vision and strategy to leverage AI aligned to regulatory guidance, then put the building blocks needed to scale its use. These include the proper IT infrastructure, talent and skillsets, and creating ecosystems and alliances to access or build AI capabilities.
In this webinar, we will explore how intelligence-driven insights can help your quality teams, with:
Speakers
Don Soong
Senior Director & GM, Quality Solutions, IQVIA
Don Soong has devoted his career to the delivery of technology solutions to the life sciences industry. Don’s experience over 25+ years has covered CRM, MDM, and Compliance solutions by combining technology, product strategy and regulatory knowledge. Don has led all aspects of the product evolution process including product management, engineering, delivery and client engagement. His ability to combine technology and business knowledge has established his expertise within IQVIA and the industry. Don currently leads the product team for IQVIA’s QMS pillar.
Mike King
Senior Director, Product & Strategy, IQVIA
As Senior Director of Product and Strategy within the Technology Solutions business of IQVIA, Michael King is responsible for ensuring that the Medical Device solutions have the necessary functionality to support the increasingly complex and diverse global regulations. He is particularly focused on optimising business workflows through intelligence driven simplification and automation within and across the Safety, Regulatory and Quality functions. Michael has over 15 years of knowledge and experience leading localised and global teams in Regulatory Affairs and Quality Assurance and has worked within the Medical and Surgical, Orthopaedic, In Vitro Diagnostic, Diagnostic Imaging, Dental and Urology sectors. Before joining IQVIA Michael was the Vice President of International Regulatory Affairs for a Dental Technology organisation and had oversight of the International Product Registration, Adverse Event Reporting and country-based Quality Management Systems. Michael holds a degree in Physics from Oxford University and briefly worked for a consulting firm in the telecommunications industry prior to beginning his career in the Medical Industry.
Matt O’Donnell
Global Lead, Life Sciences ISV Partners, Microsoft
Matt O'Donnell is currently an Industry Advisor at Microsoft. During his nine years at Microsoft, Matt has focused on strategic Pharmaceuticals and Life Sciences customers as a Client Technology Lead, Client Executive, and most recently, Life Sciences Industry Advisor. Before Microsoft, Matt's 25 years of experience involved applying innovative technology to solve complex business challenges within biopharmaceutical companies. Matt began his career as a consultant for Accenture in the Life Sciences practice, was co-founder of two successful startup companies, and was a Strategy & Product Management Director at Avaya and IPC. As a part of The Health & Life Sciences Global ISV team, Matt currently leads a portfolio of market-leading Global ISV partners focusing on the Pharmaceutical and Life Sciences industry. With the Microsoft partner ecosystem, Matt is applying Data Analytics & AI to improve processes across the pharmaceutical value chain. When not working, Matt spends time with his wife Jill, two sons, Keenan and Sean, and their ‘super mutt’, Penney. Matt lives in Doylestown, PA.
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For Heads of Quality and Regulatory in life science companies challenged to build a “quality-culture,” manage complex processes on tight timelines, and ensure compliance in a rapidly changing global environment, the importance of a fully integrated eQMS has never been greater.
In this webinar, learn how a complete eQMS platform with a comprehensive suite of software solutions can help you to:
Speakers
Michael King
Senior Director, Product & Strategy, IQVIA
As Senior Director of Product and Strategy within the Technology Solutions business of IQVIA, Michael King is responsible ensuring that the Medical Device solutions have the necessary functionality to support the increasingly complex and diverse global regulations. He is particularly focused on optimising business workflows through intelligence driven simplification and automation within and across the Safety, Regulatory and Quality functions.
Michael has over 15 years of knowledge and experience leading localised and global teams in Regulatory Affairs and Quality Assurance and has worked within the Medical and Surgical, Orthopaedic, In Vitro Diagnostic, Diagnostic Imaging, Dental and Urology sectors. Before joining IQVIA Michael was the Vice President of International Regulatory Affairs for a Dental Technology organisation and had oversight of the International Product Registration, Adverse Event Reporting and country-based Quality Management Systems.
Michael holds a degree in Physics from Oxford University and briefly worked for a consulting firm in the telecommunications industry prior to beginning his career in the Medical Industry.
Phil Johnson
Senior Principal, Quality and Compliance Solutions, IQVIA
Phil is an experienced regulatory and quality-based professional who has worked in the Medical Device, In-Vitro Diagnostic and Pharmaceutical Industries for over twenty-five years. His core expertise is in the quality and manufacturing requirements for Medical Devices, Diagnostics and Pharmaceuticals. This has included the writing, implementation and maintenance of Quality Management Systems, auditing of external suppliers and manufacturing/distribution sites and due diligence auditing.
His current role in IQVIA is Senior Principal, leading the Quality Compliance Consulting team that covers GMP & GCP consulting for both pharma and MedTech.
Prior to joining quintiles in 2002 he was an independent regulatory and quality consultant after holding different management positions within various organizations. For ten years he was the founder and Director of a UK Central Laboratory providing world-wide IVD services to the pharmaceutical industry. He has also held senior manufacturing positions in Medical device, Diagnostics and Pharmaceutical companies.
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Computer systems validation (CSV) has long been a regulatory necessity but is considered time and resource-consuming to execute. Traditional Validation processes present challenges since they extend project timeline and costs, impacting time to market, resulting in an inability for life sciences organizations to promptly deploy newer versions of the software.
Speakers
Massimo Franza
Senior Director, Software Engineering, Quality Solutions, IQVIA
Massimo Franza is Sr. Director of Software Development for Quality and Compliance Solutions at IQVIA and is responsible for the overall development, testing and release of IQVIA's Enterprise Quality Management System, SmartSolve, including technical documentation and validation packs.
With over 25 years of experience in enterprise class software applications in Europe and US, Massimo has joined IQVIA in 2007, where, before taking the role of Director of Software Development, he managed the product development and the team responsible to build SmartStudio, the Low-code Development Quality and Compliance platform used to build the integrated modules that compose the SmartSolve suite.
Expert in agile practices, Massimo is certified in IT Project Management (ITCPM) and in CMMI for Continuous Process Improvement.
Anthony Hudson
Senior Principal, Tech Quality and Compliance Solutions, IQVIA
Anthony Hudson has devoted his career to the delivery of best of breed quality systems and processes to support the life sciences industry. Anthony has over 25 years of experience covering electronic Quality Management Systems (eQMS), Program and Project Management, Quality System Auditing and Validation, solution design and solution sales. Anthony has served in several capacities in the regulated space including Director of Quality and Quality Systems. His experience brings a well-rounded customer and vendor perspective to successful quality system implementation and validation. Anthony currently leads the team of US Principals supporting eQMS sales and implementation for IQVIA’s QMS pillar.
Davor Milosevic
Safety, Regulatory, and Quality, Quality Assurance Director, IQVIA
Davor Milosevic has extensive experience within the Quality Assurance function of the life sciences industry. Over the last 15 years, Davor has designed, implemented, and maintained various GxP, Quality Assurance (QA), and Quality Control (QC) programs, as well as compliance infrastructures, including documentation (SOP) systems and training programs, and has performed hundreds of internal and external audits. He has led and managed inspections by FDA, other regulatory agencies (AABB, AATB, ISO, etc.), and commercial partners. His ability to build trust and confidence in an organization’s quality management system has established his expertise in the Quality Assurance arena. Davor is currently the Quality Assurance Director of Safety, Regulatory, and Quality for IQVIA.