Survey for Mechanism of Action (MoA) Pediatric Investigation Plans

The upcoming EU General Pharmaceutical Legislation introduces the Mechanism of Action (MoA) Pediatric Investigation Plan (PIP) as a new requirement within the Pediatric Regulation. This approach aims to ensure that pediatric development is considered based on a product’s mechanism of action, even beyond its initial indication.

Our short survey is to assess awareness, preparedness and potential challenges related to the implementation of the MoA PIP within the biopharmaceutical industry. Your input will help identify key areas of impact and support future guidance on compliance. The anonymous survey results will be incorporated into a summary publication that will be shared on ICONplc.com at a future date.

Thank you in advance for your support and input.

Are you aware of the Mechanism of Action (MoA) PIP?
Do you anticipate that the MoA PIP will impact your current drug development projects?
Are you confident in your ability to implement the MoA PIP within your organisation?
Does your organisation have the necessary expertise to address the requirements of the MoA PIP in the following areas? (Select all that apply)
Once the MoA PIP comes into force, when do you plan to address its requirements?