Paediatric Plans PIPs
Advising on the PIP tactically or strategically
Writing, or reviewing, and submitting a PIP
Responding to Paediatric Committee PDCO/EMA proposed PIP Modifications
Preparing questions and briefing package for a PDCO Clarification teleconference meeting
Arranging and managing an Oral Explanation with the PDCO
Consulting on paediatric safety and product information requirements
Paediatric product information SmPC and PL label claims