Administrative staff

Number of employees in each department and shift Administration staff... 

Additional administration staff required for the system s operation. 

Roles within a mentoring scheme (e.g. who the backers are, the program co-ordinator, supervisors, administration staff, mentors and mentees). 

As with the administration staff, line managers will only tend to require a briefing on the scheme as well as an explanation of their role. The latter should make clear to them ... 

Figure 8.1 shows the number and proportion of professional and administrative staff responsible for registration, and the equivalent number of full-time personnel. For part-timers, if there are no data on the amount of work-time, it has been assumed that they work half-time (0.5). For Cypms and Zimbabwe, where staff perform multiple functions, the total numbers of staff have been used. 

The Australian TGA is by far the largest in terms of the number of staff Venezuela and the Netherlands rank second and third, respectively. Cypms has the smallest number of registration staff—two pharmacists and three administrative staff—who are also responsible for licensing and GMP inspection. Of all the dmg regulatory authorities, only those of Australia, Cypms and Tunisia have more administrative staff than professional staff The dmg regulatory authorities of Estonia, Uganda and Zimbabwe do not employ administrative staff for the registration unit, and it is not clear whether administrative matters are handled by the professionals. 

Figure 8.5 shows the number of applications per staff member (professional plus administrative staff) and the number of applications per professional staff member. The workload per person related to registration varies greatly among the dmg regulatory authorities. Cypms has the largest load per individual professional staff member, and ranks second in workload per staff member of any grade. 

We also would like to thank Professor Doug Reeve, Chair of the Department of Chemical Engineering and Applied Chemistry at the University of Toronto, as well as the administrative staff for providing the resources and assistance for our efforts. 

The investigator in the institution conducting the study should be aware of what happens to the medical records of study subjects who have participated in clinical trials. The medical authorities or the institution should have guidelines for the retention of records before they are changed into an electronic form by scanning, microfiched or destroyed. Usually when they are changed into another form, the medical records will be reviewed by administration staff and those items deemed not essential will be... 

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. 

The Code apphes to the promotion of medicines to UK health professionals and to appropriate administrative staff in hospitals and health authorities and the like, and to information made available about those medicines to the general public. The Code does not apply to the promotion of OTC medicines (defined as those medicines primarily promoted to the general public rather than health professionals) except in certain circumstances namely, when they are promoted to a health professional with a view to the writing of a prescription rather than simply recommending the purchase of the medicine by the patient. 

In addition to IRB members, the head of the institute must appoint a study drug manager, a document archiving manager and administration staff for both clinical trials and the IRB. In order to handle clinical trials in such a complex structure, SOPs for conducting clinical trials must be prepared at the hospital. 

The aim of the Code of Practice for the Pharmaceutical Industry is to ensure that the promotion of medicines to members of the health professions and to administrative staff is carried out in a responsible, ethical and professional manner. The Code recognises and seeks to achieve a balance between the needs of patients, industry, health professionals and the general public, bearing in mind the political and social environment within which the industry operates and the statutory controls governing medicines. 

This Code applies to the promotion of medicines to members of the United Kingdom health professions and to appropriate administrative staff and to information made available to the general public about medicines so promoted. 

The Code applies to the promotion of medicines to members of the health professions and to appropriate administrative staff as specified in Clause 1.1. This includes promotion at meetings for UK residents held outside the UK. It also applies to promotion to UK health professionals and administrative staff at international meetings held outside the UK, except that the promotional material distributed at such meetings will need to comply with local requirements. 

The term representative means a representative calling on members of the health professions and administrative staff in relation to the promotion of medicines. 

The provisions of the Code apply in their entirely to the promotion of medicines to appropriate administrative staff except where the text indicates otherwise. For example, the prescribing information required under Clause 4 must be included in promotional material provided to administrative staff but it is not permissible to provide samples of medicines to them as this is proscribed by Clause 17.1. 

Abbreviated advertisements may only appear in professional publications i.e. publications sent or delivered wholly or mainly to members of the health professions and/or appropriate administrative staff. A loose insert in such a publication cannot be an abbreviated advertisement. 

Upon reasonable request, a company must promptly provide members of the health professions and appropriate administrative staff with accurate and relevant information about the medicines which the company markets. 

Substantiation for any information, claim or comparison must be provided without delay at the request of members of the health professions or appropriate administrative staff. It need not be provided, however, in relation to the validity of indications approved in the marketing authorization. 

Promotional material should be tailored to the audience to whom it is directed. For example, promotional material devised for general practitioners might not be appropriate for hospital doctors and, similarly, material devised for clinicians might not be appropriate for use with National Health Service administrative staff. 

Representatives must ensure that the frequency, timing and duration of calls on health professionals, administrative staff in hospitals and health authorities and the like, together with the manner in which they are made, do not cause inconvenience. The wishes of individuals on whom representatives wish to call and the arrangements in force at any particular establishment, must be observed. 

Attention is drawn to the requirements of Clauses 18 and 19 which prohibit the provision of any financial inducement for the purposes of sales promotion and require that any hospitality provided is secondary to the purpose of a meeting, is not out of proportion to the occasion and does not extend beyond members of the health professions or appropriate administrative staff. 

Meetings organised for groups of doctors, other health professionals and/or appropriate administrative staff which are wholly or mainly of a social or sporting nature are unacceptable. 

Reply paid cards which refer to representatives delivering items which have been offered to health professionals or appropriate administrative staff should explain that there is no obligation to grant the representative an interview when the item is delivered. This is to avoid the impression that there is such an obligation, which would be contrary to Clause 15.3 which prohibits the use of any inducement to gain an interview. 

All relevant personnel including members of staff concerned in any way with the preparation or approval of promotional material or of information to be provided to members of the UK health professions and to appropriate administrative staff or of information to be provided to the public, must be fully conversant with the requirements of the Code. 

Samples of a product may be provided only to a health professional quahfied to prescribe that product. They must not be provided to administrative staff. 

No gift, benefit in kind or pecuniary advantage shall be offered or given to members of the health professions or to administrative staff as an inducement to prescribe, supply, administer, recommend or buy any medicine, subject to the provisions of Clause 18.2. 

Gifts in the form of promotional aids and prizes, whether related to a particular product or of general utility, may be distributed to members of the health professions and to appropriate administrative staff, provided that the gift or prize is inexpensive and relevant to the practice of their profession or employment. 

Administrative staff may he invited to meetings where appropriate. For example, receptionists might be invited to a meeting in a general practice when the subject matter related to practice administration. 

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