Scientific advice meetings

A pre-submission meeting with the EMEA Secretariat is encouraged and is free. It is especially advisable if it is the applicant s first experience in seeking scientific advice, and should usually be scheduled about 1 to 2 months before submitting a request. This meeting is valuable for guidance on the scientific advice procedure and for help with the structure/content of the request. There is an EMEA Scientific Advice Guidance Document available to the applicants. The applicant should inform the EMEA Secretariat of the intention to submit an application about 2 weeks before the submission of request and then, once the appropriate fees have been paid, the procedure can start. 

At the SAWP meeting, two coordinators are appointed, to whom the applicant should submit the full documentation. These two coordinators have a deadline of 20 days by when they should circulate to all the members their individual first reports on draft CHMP advice. These are discussed at the next meeting of SAWP (Day 30) and, if there is no disagreement, a Joint Report is adopted and the final scientific advice letter is prepared for adoption by the CHMP (Day 40). Typically, however, there is often a lack of consensus between the two coordinators or other members of SAWP and there is a need for further discussion. Therefore, the applicant is invited for an oral explanation and a Joint Report is prepared which is discussed at the following meeting (Day 60). This may result in a final scientific advice letter being prepared (Day 60) for adoption by CHMP on day 70. Exceptionally, a decision is made on whether to constitute an expert meeting (and if necessary, when to do so) or request... 

The case-by-case approach that is needed for the effective preclinical development of biopharmaceuticals requires close collaboration and agreement between the sponsor and the regulatory agency at all stages of development. In the United States, such collaboration and scientific advice is often achieved through interaction with the FDA at pre-IND, end of phase 2, or pre-NDA meetings with the Agency. 

Provide MHRA with expert advice on pre-meeting scientific advice documentation for within scope compounds. 

Madelin, Robert (2004) The Importance of Scientific Advice in the Community Decision Making Process . Director General for Health and Consumer Protection, the European Commission. Presentation given at the inaugural joint meeting of the members of the non-food scientific committees, Brussels, 7 September 2004. 

Anonymus (1986) Oslo Commission Guidelines for the Disposal of Dredged Material. Standing Advisory Committee for Scientific Advice for the Oslo Commission. Thirteenth Meeting, Amsterdam, March 10-14, 1986. 

The CP is the only EU approval procedure where a communication with the competent authority is requested before filing. Even though many national agencies are open for early advisory meetings, i.e., so-called scientific advice procedures, these are all voluntarily. Only for the CP has one to contact the European agency (EMEA) in advance. 

The recommendations of the JECFA and the JMPR are recognised as sound scientific advice and many countries base their food laws and regulations on them. The Joint FAO/WHO Food Standards Programme, implemented through the Codex Alimentarius Commission, also makes use of the JECFA and JMPR recommendations. In the course of their work the Codex Committee on Food Additives and the Codex Committee on Pesticide Residues develop maximum levels (ML) or maximum residue levels (MRL), respectively, which form important parts of individual food standards. The Codex Alimentarius Commission is developing these standards to meet its two major objectives, namely to protect the health of the consumer and to ensure fair practice in the food trade. 

As this paper is primarily concerned with the activities of Joint Meetings of Experts (JMPR), it seems sufficient to record that since 1966 the CCPR has held ten sessions of intergovernmental discussions aiming at common limits for residues of pesticides in food commodities. They have been based on the recommendations of Joint FAO/WHO Meetings of Experts which have been used throughout this time as an independent international source of scientific advice relating to the occurrence of residues of pesticides in food. 

With the publication of Vol. 51, the editors and the publisher would like to take this opportunity to thank authors and readers for their collaboration and their efforts to meet the scientific requirements of this series. We appreciate our authors concern for the progress of Polymer Science and we also welcome the advice and critical comments of our readers. 

The NRC subcommittee s review of the AEGL reports prepared by NAC and its contractors involves oral and written presentations to the subcommittee by the authors of the reports. The NRC subcommittee provides advice and recommendations for revisions to ensure scientific validity and consistency with the NRC guideline reports (NRC 1993, in press). The revised reports are presented at subsequent meetings until the subcommittee is satisfied with the reviews. Because of the enormous amount of data presented in the AEGL reports, the NRC subcommittee can not verify all the data used by NAC. The NRC subcommittee relies on NAC for the accuracy and completeness of the toxicity data cited in the AEGLs reports. 

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