Translation of "Prüfkonzept" in English

At the beginning of October the EU authorities approved a pediatric investigation plan for Avastin.

The inspection concept of the SGS-TÜV Saar acts as a guarantor for a consistently high product quality.

TÜV NORD is involved in the research project as implementation partner for the testing concept.

Therefore, the sampling plan for Campylobacter is based on the testing plan for Salmonella.

Hermes Hansecontrol also offers a tailored test package for increased loads.

So a testing concept for isocyanate containing laminates could be formulated.

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 inspection concept, which was developed at Fraunhofer IPA is based on this ability.

The PC-based test concept should offer a flexible, user-friendly and replicable definition of the tests.

Regardless of the product to be tested – we have the right test concept and supply the turnkey system solution.

The Management Board was notified of the first legal case regarding a paediatric investigation planrelated application.

The Applicant should conduct this integrated analysis according to an agreed protocol including samples from all available historical samples from previous studies (NIH991265/20010769, FHA 101, NASH4 and obesity studies) with patients with GL/PL and samples obtained from patients that will be included in the efficacy and safety study in PL patients, the paediatric investigational plan (PIP) study and the patients registry.

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 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.

The paediatric investigation plan shall specify the timing and the measures proposed to assess the quality, safety and efficacy of the medicinal product in all subsets of the paediatric population that may be concerned.

The paediatric investigation plan should include details of the timing and the measures proposed to demonstrate the quality, safety and efficacy of the medicinal product in the paediatric population.

In order to reduce the administrative burden for food business operators, the sampling plan for the criterion on Campylobacter should follow the same testing approach as for the process hygiene criterion set for Salmonella in poultry carcases.

Where an application under Articles 8 or 9 includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, the holder of the patent or supplementary protection certificate shall be entitled to a six-month extension of the period referred to in Articles 13(1) and 13(2) of Regulation (EEC) No 1768/92.

Therefore, an additional requirement for applying for a marketing authorisation that includes the results of studies conducted in compliance with an agreed paediatric investigation plan should be an obligation for the applicant to indicate how he proposes to ensure the long-term follow-up of possible adverse reactions to the use of the medicinal product and efficacy in the paediatric population.

Amendment 69 on the eligibility of paediatric studies initiated prior to entry into force to be included in a paediatric investigation plan is redundant since the Commission has accepted amendment 62 which deals with the same situation.