Accovion Plus

Pediatric Investigation Plan (PIP)

The European Medicines Agency mandates the submission of a Pediatric Committee-approved Pediatric Investigation Plan (PIP) with all Marketing Authorization Applications. Ensure compliance and receive extended patent protection and market exclusivity with a fully compliant PIP commensurate with your specific needs.

The PIP requirement for new medicinal products not yet authorized in the European Union aims to ensure and oversee high quality research into medicines for children. Accovion offers an integrated solution package that helps to minimize the impact on your business. We assist in converting the challenges of this new requirement into tangible benefits.

Challenges

• Your marketing authorization (including for use in adults) will be delayed or denied without an approved PIP.
• When you prepare a PIP for a new compound, you must rely on published literature because information on efficacy and safety is limited in early drug development.
• You risk binding yourself to unworkable protocols unless the PIP is well designed and is based on experience in pediatric drug development and trial management.

Solutions

Accovion has the expertise to:

• Manage your PIP project.
• Coordinate input from your clinical, preclinical and pharmaceutical formulation experts.
• Conduct literature searches and review published material.
• Prepare your PIP document and pediatric protocol synopses.
• Prepare your electronic PIP.
• Track and manage your PIP from submission to approval.
• Modify your approved PIP as the adult program progresses.

Benefits

• 6 months patent extension
• 2 years market exclusivity added to the 10-year exclusivity for orphan-designated medicinal products
• 10 years of data protection for off-patent medicines developed specifically for pediatric use

Experience you can count on

Accovion’s board-certified pediatricians and a team of specialists in pediatric clinical studies in all functions will assist with your PIP. You’ll also benefit from Accovion’s long track record of conducting pediatric studies in many indications and in all pediatric age groups. Trust Accovion to produce the fully compliant PIP documentation you need within your specified timelines. For more information, click here for a downloadable brochure.