Event was cancelled.

However, if you are interested in this workshop please reach out and Agilis will reschedule with an exclusive invitation.

Integrating Human Factors into Your Next Regulatory Submission: Lemons or Lemonade?

Often regulatory professionals are responsible for ensuring all human factors requirements for regulatory submissions are met, even though they may be unfamiliar with the subject. With increasing complexity in the global regulatory landscape and related human factors requirements, regulatory professionals need specific knowledge about human factors to prevent this key requirement from derailing regulatory submissions or causing unnecessary post-submission delays, such as additional studies or other regulatory requirements. This workshop is for the regulatory professional who wants to successfully navigate crucial aspects of human factors and prevent obstacles and risks to your submissions.

Learning Objectives 

After completing the virtual class, you will be able to:

• Overview of regulatory requirements relating to human factors including introduction to key human factors standards and guidance

• Defining what human factors is (and is not) and general requirements of human factors submissions

• Purpose and benefits of different types of human factors studies related to regulatory submissions

• Planning considerations for human factors activities

• Planning for and conducting successful regulatory authority interactions

• Monitor product development and human factors timeline and activities to identify impacts to the regulatory submission timeline

• Determining preparedness for HF validation

• What a successful human factors validation looks like (and when a validation becomes an unexpected formative)

• Determining and presenting residual risk post-validation

• Strategies for using human factors data to support design decisions and provide rationale to regulatory authorities as part of regulatory interactions or submissions