In the dynamic landscape of regulatory affairs within the medical device, IVD, and pharmaceutical/biologics industries, confusion often arises between Regulatory Strategies, Plans, and Tactics. This webinar aims to unravel this confusion by delineating the differences between a Regulatory Strategy and a Regulatory Plan, offering practical insights to streamline operational processes and enhance strategic clarity.
Drawing from extensive experience in Regulatory Affairs, our experts will address the impact of operational confusion, highlighting the inefficiencies and risks associated with mismanagement. Attendees will gain valuable insights into generating and communicating a clear Regulatory Strategy for new or modified healthcare products, enabling stakeholders to align strategic objectives effectively.
This webinar is designed for regulatory affairs professionals, product development teams, quality assurance personnel, compliance officers, regulatory consultants, and decision makers/stakeholders involved in medical device, in vitro diagnostic, pharmaceutical, and biologics industries. Whether you’re responsible for regulatory compliance, product development, or strategic planning, this webinar provides essential insights into Regulatory Strategy and Regulatory Plan concepts to optimize processes and drive success in healthcare product development projects.
This workshop covers the following topics:
Acquire the skills to generate, communicate, and articulate a clear Regulatory Strategy for new or modified healthcare products, ensuring alignment with organizational objectives and regulatory requirements.
Risk Communication and Stakeholder AlignmentEnhance your ability to communicate risks, probabilities, and the likelihood of success associated with strategic Regulatory options, empowering key stakeholders and decision makers to align on the most appropriate Regulatory Strategy for optimal outcomes.
Identification of Critical InputsGain proficiency in identifying and leveraging critical inputs essential for crafting effective and meaningful Regulatory Strategies.
Regulatory Strategy Generation and ManagementDevelop the capability to generate a Regulatory Strategy based on critical inputs (e.g., Target Product Profile) and focusing stakeholders on tactical plan execution as new product development progresses.
All participants will receive a certificate of attendance upon completion of the workshop.
Note: Registration closes one week prior to the start of workshop.
AAPS
Instructor
Arthur (Art) Kawasaki, M.Sc., MBA: Art has over 29 years of Regulatory Affairs, Quality and Clinical Affairs experience within the pharmaceutical, biologics, medical devices and IVD industries. Arthur has worked and held senior associate through to senior leadership positions at Eli Lilly (1998-2002), Becton Dickinson (2002-2014), Canon Biomedical (2014-2018), DiaSorin Molecular (2018-2021) and most recently Exact Sciences (2021-2023), where he was the VP, Regulatory Affairs. Mr. Kawasaki holds a Bachelor and a research thesis based Master of Science degrees in Physiology from the University of Toronto and a Master of Business Administration in Marketing from York University.
AAPS
Instructor
Kandarp Shah, Ph.D., RAC: Kandarp has 8 years of experience with US 510(k) and PMA applicable products, including IDE approvals and EU IVDR/MDR/CE marking as well as worldwide registrations for IVD products and permanent implants. His experience includes LDT, CLIA high/medium-complexity and CLIA-waived products and point of care diagnostics. He also has over 10 years of progressive experience in molecular and cellular biology, immunology, cardiovascular disease, and tissue-based diagnoses in research laboratories. Kandarp has worked with Carl Zeiss, Exact Sciences and other organizations. Dr. Shah holds a Ph.D. in Biological Sciences with a focus on cellular/molecular biology from the University of California Irvine.
