Program Details

Time

One and Half hours

Cost

CAD $600 + HST

Location

Online

Abstract

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

Other Regulatory Recorded Webinars Available