Medical departments

Thiamine, whose structure is shown in Figure 18.17, is known as vitamin Bj and is essential for the prevention of beriberi, a nervous system disease that has occurred in the Far East for centuries and has resulted in considerable sickness and death in these countries. (As recently as 1958, it was the fourth leading cause of death in the Philippine Islands.) It was shown in 1882 by the director-general of the medical department of the Japanese nayt that beriberi could be prevented by dietary modifications. Ten years later, Christiaan Eijkman, a Dutch medical scientist working in Java, began research that eventually showed that thiamine was the... 

Katja Sibyile Muhlberg, Ralph Paschke HI. Medical Department, University of Leipzig Leipzig, Germany... 

Medical Department, Allergy Division, Spital Ziegler, Spitalnetz Bern Morillonstrasse 75-91, CH-3007 Bern (Switzerland)... 

Flansen, S., Stamm-Balderjahn, S., Zuschneid, I., Behnke, M., Ruden, FI., Vonberg, R. P., and Gastmeier, P. (2007). Closure of medical departments during nosocomial outbreaks data from a systematic analysis of the literature. J. Hasp. Infect. 65, 348-353. 

Blood specimens of approximately 5 mL were collected on two separate days during the week preceding the study. Additional blood specimens of approximately 5 mL each were collected approximately 24 and 48 hr after the start of the study. These blood specimens were drawn and assayed for plasma cholinesterase activity by personnel from the Michigan Division Medical Department of The Dow Chemical Company. 

The Army didn t act to shield itself from further criticism until the mid-1970s, when Congress began to feel increasing pressure from critics. Only then, did its members request a systematic search for possible after effects in former LSD volunteers. Lieutenant Colonel David A. McFarling, MD, a psychiatrist assigned to the Walter Reed Army Institute of Research (WRAIR) in DC, accepted the task. He designed a comprehensive follow-up study of all volunteers who had received LSD under Chemical Corps auspices. In October 1980, the US Army Medical Department, US Army Health Services Command, published his report. 

Army Medical Research and Development Command Contract Review Board and the Surgeon General s Human Use Committee and Clinical Investigation Committee, to insure uniform application of ethical standards for human research studies conducted within or sponsored by the Army Medical Department and other Army Agencies. 

This chapter outlines these areas of responsibility and the key players who are needed to fulfil these. It also describes how, by working in crossfunctional teams, the members of the medical department contribute to the process of product development. 

To this end, the major areas of responsibility for the medical department are to ... 

How these responsibilities are shared among the members of a medical department will become apparent from the descriptions of the various roles in Section 10.3. The degree to which the medical department is usually involved in what is traditionally described as the four phases of clinical development will also be outlined. 

The medical department is usually headed by a senior pharmaceutical physician (the medical director), who is supported by a team consisting of other physicians, graduates and administrative staff. The non-medical graduates are normally pharmacists or life scientists and, in addition to providing informed scientific input, may look after some administrative areas. In some companies they, rather than the physicians, may be responsible for staff management, thus allowing the physicians to concentrate on their advisory roles. 

Key players from the medical department are likely to be as follows, although not every company will place all these specialists within the medical department ... 

In whatever way it is organised, the medical department will of course need the support of the human resources department as well as administrative and secretarial services. Thus, while it is not possible to propose any specific organisational structure for a medical department, the organogram presented in Figure 10.1 reflects the issues that need to be considered when deciding on the preferred organisation within the company. 

There are certain personal attributes over and above a medical degree and clinical experience that make for a successful pharmaceutical physician. To be valued, the pharmaceutical physician must be able to provide insight into the clinical benefit, and hence the commercial potential, of a compound at any stage in its development. He or she must also have the planning skills to realise that potential, and an ability to communicate at all levels, both inside and outside the company. If the medical department is to act as the compan)r s medical conscience (see Section 10.2),... 

To be effective, the pharmaceutical physician in the medical department has to recognise both... 

The pharmaceutical physician provides a medical direction to marketing strategy and ensures that product literature and promotional material are legal and factually accurate. This is an important contribution to the medical department s role as medical conscience, as discussed in Section 10.2. Medical input remains necessary to the servicing and support of marketed products throughout their life cycle. 

The introduction of GCP has accelerated the need for quality control and quality assurance, particularly in the field of clinical research. Quality control is carried out by the staff who are responsible for the particular activity, working to SOPs that cover all the tasks under scrutiny. SOPs not only need to be written but must also be updated regularly. Quality assurance is the process which seeks to confirm that SOPs have been observed this is accomplished by the process of auditing. Internal audit departments should be under a separate management from the medical department. Regular audits can not only assure external bodies, such as regulatory authorities, that proper procedures have been followed, but also serve to deter those rare attempts at fraud on the part of clinical investigators, which occasionally become evident. ... 

Within the medical department there may be two types of information support. There will be medical information scientists, who provide the external scientific service, now required by Article 13 of Directive 92/28/EEC (on advertising) of the Council of the European Communities. In addition, there may be those, sometimes called scientific advisers, who provide specialised information support to a product or therapy area within the company. Many medical information scientists are qualified pharmacists. 

The regulatory department may be part of the medical department or the research function. 

Effective handling of all information relating to drug safety is one of the most important responsibilities, if not the most important responsibility, of the medical department. The size of a company and the volume of work will dictate whether the responsibility for monitoring drug safety resides with members of staff who have... 

It is clear that while the medical department can be seen to be a team in itself, its members play on many other different teams. A successful medical department is one that is contributing to the commercial success of the company while maintaining the highest professional and ethical standards. 

Holden P. The role of the Medical Department. Pharmaceutical Times November 1992 12. 

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