The Paediatric Committee shall be composed of the following members
Assessments of the following by the Paediatric Committee shall be free of charge
The tasks of the Paediatric Committee shall include the following
At meetings of the Paediatric Committee, they may be accompanied by experts.
These five members with their alternates shall be appointed to the Paediatric Committee by the Committee for Medicinal Products for Human Use
As soon as the Paediatric Committee adopts an opinion, the procedure laid down in Article 25 shall apply.
It is appropriate to set a deadline for the submission of a paediatric investigation plan in order to ensure early dialogue between the sponsor and the Paediatric Committee.
The Agency shall fulfil the secretariat functions for the Paediatric Committee and shall provide it with technical and scientific support.
Whenever appropriate, the Paediatric Committee may request the applicant to supplement the particulars and documents submitted.
Within the same period, either the applicant or the Paediatric Committee may request a meeting.
Associate Member – AACR (American Association for Cancer Research)
At meetings of the Committee for Advanced Therapies, they may be accompanied by experts.
At meetings of the Committee for Advanced Therapies, they may be accompanied by experts.
Belgian Koenraad Norga elected as new chair of EMA’s Paediatric Committee
Setting up a Paediatric Committee within the European Medicines Agency (EMEA).
The EESC considers that the Paediatric Committee's responsibilities should be broadened at the outset.
These five members with their alternates shall be appointed to the Paediatric Committee by the Committee for Medicinal Products for Human Use;
These five members with their alternates shall be appointed by the Committee for Medicinal Products for Human Use;
He is the Past Chair of the Canadian Pediatric Anesthesia Society and a member of the Pediatric Committee of the World Federation of Societies of Anesthesia.
If such a consensus cannot be reached, the Paediatric Committee shall adopt an opinion consisting of the position of the majority of the members.
Either the applicant or the Paediatric Committee may request a meeting during that 60-day period.
Membership includes representatives from the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO), and the Committee for Advanced Therapies (CAT).
Commission Call for Expression of Interest for the position of member for the Paediatric Committee (PDCO).
› First studies started further to the opinion formulated by the Paediatric Committee of the EMA
The Paediatric Committee shall draw up its rules of procedure for the implementation of its tasks.
Requêtes fréquentes français :1-200, -1k, -2k, -3k, -4k, -5k, -7k, -10k, -20k, -40k, -100k, -200k, -500k, -1000k,
Requêtes fréquentes anglais :1-200, -1k, -2k, -3k, -4k, -5k, -7k, -10k, -20k, -40k, -100k, -200k, -500k, -1000k,
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