Scientific advice

Pre-authorization evaluation of medicines for human use unit. This unit provides scientific advice relating to quality, safety and efficacy issues, as well as relating to orphan drugs. 

To those who knew him personally, Burwell was not only an imposing intellect, but a warm, deeply caring, pleasant person, and a complicated individual with many facets. For instance, while wise and judicious, he nevertheless conducted himself with a great sense of humor and wit. Any whom he favored soon realized he could engage in lively conversation on practically any subject. Many of his coworkers also remembered him for his perceptive scientific advice and suggestions. Often in seminars, students felt that they learned more about a subject from Burwell s probing questions than from the seminar itself. His family remembered him also as a caretaker extraordinaire. His devotion to his beloved Elise, particularly during the last year of her life, will be remembered by all. 

On December 28, 2006 Professor Ferro suddenly died. After working for so many years under his direction, I feel indebted not only for his valuable scientific advice, but above all for the precious example he gave me through his dedication to science and teaching. Intermetallic compound chemistry, the subject matter of this book, is the focal point of Prof. Ferro s scientific activity and the subject to which he has dedicated his professional life. 

Sources of information Possible sources of scientific information include advocacy groups, the media, universities or other research organizations, government agencies, contract research, NGOs, and scientific publications. In the case of POPs decisionmakers have gotten scientific advice from international conferences the internet, and scientific journals. There are also professional organizations such as Stockholm Convention Implementation Office of SEPA (CIO). 

Where do US Decision Makers Get Scientific Advice (LANDIS Wayne, LESTER Steven, USA)... 

The principal scientific bodies of the EMEA are the Committee for Proprietary Medicinal Products (CPMP) and the Committee for Veterinary Medicinal Products (CVMP). These committees have two members from each member state as well as from Norway and Iceland which are appointed to give independent scientific advice to the EMEA. 

This working party considers the aspects of the manufacture and control of biotechnological and biological medicinal products and is also involved in the provision of scientific advice. Workshops on the applieation of assays for markers of transmissible spongiform encephalopathies (TSE) and on the potential risk of transmitting new variant Creutzfeld-Jakob disease (nv-CJD) through plasma-derived medicinal products have recently been held. 

For the purpose of providing expert scientific advice and recommendations to the Secretary regarding a... 

In order to encourage pharmaceutical companies to invest in orphan drug development, legislation provides for a number of incentives. These include application fee waiver (the extent of reduction varies with the region of the world, and in the European Union it is 50% for all fees since 2002), market exclusivity and protocol assistance. In the European Union, there is 100% reduction in the fee applicable to the provision of any scientific advice. The fund made available by the Community for fee exemptions for orphan medicinal products amounts to= 3 700000 in 2005. 

Applicants are free to solicit advice from individual Member States and according to various surveys conducted by the European Federation of Pharmaceutical Industries and Associations, they often do. Apart from the FDA, these surveys reveal, the EU Member States most often consulted are Germany, France, Sweden and the United Kingdom. Flowever, it is often important to secure a pan-European advice. Article 51 of Council Regulation EEC/2309/93 requires the EMEA to provide the Member States and the institutions of the Commimity with the best possible scientific advice on any question relating to the evaluation of the quality, the safety and the efficacy of medicinal products for human... 

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... 

Details of guidance for companies requesting scientific advice and protocol assistance can be accessed on the EMEA website (see end of chapter). 

The authors are most grateful to Dr Agnes Saint Raymond, Head of Sector Scientific Advice and Orphan Drugs and Acting Head of Sector Safety Efficacy, European Medicines Agency, London for her valuable and constructive comments during the preparation of this chapter. Any errors, however, are entirely the responsibility of the authors. 

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