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.
Who Should Attend
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.
Workshop Outline
This workshop covers the following topics:
Differentiating Regulatory Strategy and Regulatory Plan
Exploring Critical Inputs (e.g., Target Product Profile) to a Regulatory Strategy
Understanding Components of a Regulatory Strategy
Understanding Components of a Regulatory Plan
Case Study Examination of a Regulatory Strategy
Interactive Q&A Session
Learning Outcomes
Regulatory Strategy Development and Communication
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 Alignment
Enhance 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 Inputs
Gain proficiency in identifying and leveraging critical inputs essential for crafting effective and meaningful Regulatory Strategies.
Regulatory Strategy Generation and Management
Develop 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.
Recorded Webinar – Regulatory Strategy – Medical Devices and other Health Technologies