Tag Archives: Paediatric Committee

EMA Publish Roles and Responsibilities for the Paediatric Committee (PDCO)

Posted on October 20, 2010 by admin| Leave a comment

EMA Publish Roles and Responsibilities for the Paediatric Committee (PDCO).

Full Text Here

The following should be read in conjunction with the Rules of Procedure of the Paediatric Committee (current status draft). Heavy workload is expected in the first years; therefore, a contribution from every member of the Committee is needed. The Committee has a huge responsibility in terms of Public Health towards the children that may be included in the trials and studies requested. There are high expectations from the public and stakeholders, and the Committee should deliver scientific opinions of the highest quality to achieve the objectives of the Regulation, develop high quality ethical paediatric research, increase the availability of medicinal products intended for the paediatric population and that of information on paediatric use.

For Assistance with PDCO Regulations Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Paediatric Investigation Plans – New Regulations

Posted on October 7, 2008 by admin| 3 Comments

New regulations have come into force relating to the development of drugs for Children, and these regulations will impact on every single drug development programme currently ongoing. It is critical that you know about these regulations and how to adapt to them.

Every product must have agreed a Paediatric Investigational Plan (PIP) with the EMEA (via the PDCO – Paediatric Committee) before they register their product. In the future this will change to every product must be implementing a PIP before they can register their product.

The PIP describes the investigation that you propose to do in order to establish safety and efficacy in a paediatric population. You must put this plan together with the expectation of carrying it out. Every product must have one, it will not be acceptable to just say “children don’t get this disease” you will have to prove it.

The committee will not give a waver for any technology that can not prove that their therapy could benefit children. If there are enough Paediatric Patients to power a comparison study it will have to be undertaken.

If you would like to know more about these rules have a look at the this website.

We will be publishing more information on this in the near future.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com

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Posted in regulatory

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