Übersetzung für "Investigation plan" in Deutsch

The paediatric investigation plan should be the basis upon which compliance with that requirement is judged.

The paediatric investigation plan will be the basis upon which compliance with this requirement is judged.

The application shall also include the decision of the Agency agreeing the paediatric investigation plan concerned.

This application contains the results of pre-clinical studies, investigation plan, patients' information, declaration of approval as well insurance confirmation.

In addition a PIP, thus a Paediatric Investigation plan, must be provided and approved.

It will also, in some cases, facilitate a deferral request regarding the submission of the ‘paediatric investigation plan’, without delaying the placing on the market of the adult version.

Companies intending to submit a marketing-authorisation application for a medicine they are developing for use in children or adolescents must first submit a paediatric investigation plan (PIP), setting out the studies they will conduct to demonstrate the quality, safety and efficacy of their medicine when used in these populations.

Any other marketing authorisation holder sponsored studies which involve the use in the paediatric population of a medicinal product covered by a marketing authorisation, whether or not they are conducted in compliance with an agreed paediatric investigation plan, shall be submitted to the competent authority within six months of the completion of the studies concerned.

Besides, Article 29(1) of the Commission proposal opens the centralised procedure to marketing authorisation applications which include one or more paediatric indications selected on the basis of studies conducted in compliance with an agreed paediatric investigation plan.

Amendment 40 (except the last part) aimed at establishing a deadline for the Paediatric Committee to adopt an opinion and to clarify that the request and opinion may refer to a paediatric investigation plan, deferral or waiver.

In the case of devices other than those referred to in paragraph 2, Member States may authorize manufacturers to commence clinical investigations immediately after the date of notification, provided that the ethics committee concerned has delivered a favourable opinion with regard to the reviewed clinical investigation plan.”

In the case of applications as referred to in Articles 8 and 9, the paediatric investigation plan shall be submitted with a request for agreement, unless otherwise justified, not later than upon completion of the human pharmaco-kinetic studies in adults specified in Section 5.2.3 of Part I of Annex I to Directive 2001/83/EC, so as to ensure that an opinion on use in the paediatric population of the medicinal product concerned can be given at the time of the assessment of the marketing authorisation or other application concerned.

Because the paediatric population is in fact made up of a number of subpopulations, the paediatric investigation plan should specify which subpopulations need to be studied, by what means and by when.

The paediatric investigation plan will be the document upon which the studies in children are based and will have to be agreed by the Paediatric Committee.

The requirements above will require the Competent Authorities to check compliance with the agreed paediatric investigation plan at the existing validation step for marketing authorisation applications.

Since all paediatric clinical trials conducted in the Community are already covered by Directive 2001/20/EC and entered into the European database, the first paragraph of the provision needs to make it clear that the additional requirement introduced by this Regulation is to enter details of clinical trials conducted in third countries and contained in agreed paediatric investigation plan.