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DID Training Course on Pediatric Investigation Plans (PIP) Course #13503 15-16 April 2013 Hotel Mercury Amsterdam AAN de Amstel, Amsterdam, the Netherlands Faculty Bette Due To lade (Course Director)

How to fill out paediatric investigation plans pip

How to fill out paediatric investigation plans (PIP)?

1. Familiarize yourself with the regulatory requirements: Before filling out PIP, it is essential to understand the guidelines and regulations provided by the regulatory authorities. This will ensure that you include all the necessary information and meet the required standards.
2. Identify the relevant medicinal product: Determine the medicinal product for which the PIP is being prepared. This could be a new drug or an existing drug for which additional information on its use in the paediatric population is required.
3. Conduct a thorough literature review: Review existing literature to identify any relevant data on the use of the medicinal product in paediatric patients. This will help in determining the key areas that need to be addressed in the PIP.
4. Define the objectives of the investigation: Clearly outline the objectives of the paediatric investigation. This includes specifying the population to be studied, the endpoints to be evaluated, and any specific safety concerns that need to be addressed.
5. Design the study plan: Develop a study plan that outlines the proposed study design, including the number of patients, age groups, dose selection, duration of the study, and any additional assessments or tests that are required.
6. Address ethical considerations: Consider the ethical aspects of the paediatric investigation, including the need for informed consent, assent from minors, and any special considerations for vulnerable populations.
7. Prepare the PIP application: Compile all the necessary information, including a summary of the medicinal product, proposed study plan, and supporting documentation. Ensure that the application is complete and accurate before submission.

Who needs paediatric investigation plans (PIP)?

1. Pharmaceutical companies: Companies involved in the development and marketing of medicinal products for human use, including drugs, biologics, and medical devices, need to submit PIPs as part of their regulatory requirements.
2. Regulatory authorities: National regulatory authorities, such as the European Medicines Agency (EMA), require pharmaceutical companies to submit PIPs for assessment and approval. These authorities assess the safety, efficacy, and quality of medicinal products intended for use in the paediatric population.
3. Healthcare professionals: Paediatricians and other healthcare professionals who treat paediatric patients rely on the information provided in PIPs to ensure the safe and effective use of medicines in children.
4. Patients and their families: Paediatric patients and their families have a vested interest in having access to safe and effective medicines. PIPs help to ensure that the necessary studies are conducted to generate evidence on the use of medicines in the paediatric population.

Overall, filling out PIPs requires a comprehensive understanding of regulatory requirements, a thorough review of existing literature, careful study design, and consideration of ethical considerations. This ensures that the necessary data is generated to support the safe and effective use of medicinal products in paediatric patients.

For pdfFiller’s FAQs

What is paediatric investigation plans pip?

Paediatric Investigation Plan (PIP) is a detailed research and development plan for the study of a medicine in children.

Who is required to file paediatric investigation plans pip?

Any company developing a medicine for use in children is required to file a Paediatric Investigation Plan (PIP).

How to fill out paediatric investigation plans pip?

To fill out a Paediatric Investigation Plan (PIP), companies must provide detailed information on the development, safety, and efficacy of the medicine in children.

What is the purpose of paediatric investigation plans pip?

The purpose of a Paediatric Investigation Plan (PIP) is to ensure that medicines used in children are thoroughly tested for safety and efficacy.

What information must be reported on paediatric investigation plans pip?

Paediatric Investigation Plans (PIPs) must include details on the proposed paediatric studies, plans for pharmacovigilance, and a justification for any deferrals or waivers.

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