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Pediatric Investigation Plans1011 April 2018 Hilton Canary Wharf, London, United KingdomOVERVIEW This course will provide a full introduction to Pips and the EU Pediatric Regulation. The course faculty

How to fill out paediatric investigation plans

How to fill out paediatric investigation plans

1. Start by gathering all necessary information about the pediatric investigation plan requirements.
2. Identify the purpose of the investigation plan and understand the specific regulatory guidelines that apply.
3. Create a comprehensive outline or template to structure the plan.
4. Clearly define the study objectives and endpoints that need to be addressed in the plan.
5. Determine the study population and justification for including specific age groups.
6. Develop a detailed protocol that outlines the study design, methodology, data collection, and analysis.
7. Include information on the proposed study timeline, budget, and resources required.
8. Clearly describe the ethical considerations and informed consent procedures for involving pediatric participants.
9. Provide a thorough risk-benefit analysis to demonstrate the safety and efficacy of the proposed investigation.
10. Seek input and review from experts in pediatric medicine, regulatory authorities, and ethics committees to ensure the plan meets all necessary requirements.
11. Revise and refine the plan based on feedback and ensure it complies with all regulatory and ethical standards.
12. Once the plan is finalized, submit it to the appropriate regulatory authorities for approval.
13. Regularly monitor and update the plan as necessary throughout the course of the investigation.

Who needs paediatric investigation plans?

1. Pharmaceutical companies developing new drugs or therapies that may be used in pediatric populations.
2. Researchers conducting clinical trials involving pediatric participants.
3. Regulatory authorities responsible for evaluating the safety and efficacy of medications for use in children.
4. Pediatricians and healthcare professionals involved in pediatric patient care.
5. Ethics committees overseeing research involving pediatric participants.

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What is paediatric investigation plans?

A Paediatric Investigation Plan (PIP) is a formal document that outlines the strategy for studying a medicinal product in children. It is required by regulatory authorities to ensure that necessary clinical data is obtained to support the use of medicines in the paediatric population.

Who is required to file paediatric investigation plans?

Sponsors of clinical trials, typically pharmaceutical companies or research organizations, are required to file paediatric investigation plans with the relevant regulatory authorities.

How to fill out paediatric investigation plans?

Filling out a paediatric investigation plan involves providing detailed information about the medicinal product, the planned studies, the rationale for investigating in children, timelines, and how the studies will address specific paediatric needs.

What is the purpose of paediatric investigation plans?

The purpose of paediatric investigation plans is to ensure that necessary data on the efficacy and safety of medicines for children is collected, thus facilitating the approval of paediatric-specific treatments and improving healthcare for this population.

What information must be reported on paediatric investigation plans?

Information required in a paediatric investigation plan includes the product's intended use, pharmacokinetic and pharmacodynamic studies, the justification for paediatric studies, the proposed study designs, and plans for recruiting paediatric populations.