Academy of Applied Pharmaceutical Sciences (AAPS) Webinar:
Regulatory Strategy – Medical Devices and other Health Technologies
16 October 2024
1pm – 2pm
- Registration deadline: 9 October 2024
- Registration Fee: $395
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.
All participants will receive a certificate of attendance upon completion of the workshop.
Learning Outcomes:
- 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.
- 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.
- Gain proficiency in identifying and leveraging critical inputs essential for crafting effective and meaningful Regulatory Strategies.
- 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.