Medical affairs

Heilung,/. healing, curing, cure. Heilungsvorgang, m. healing process. Heil-verfohren, n. healing process, -wasser, n. curative water, mineral water, -wert, m. therapeutic value. -wesen, n. medical affairs, -wirkung,/. curative effect, -wissen-schaft,/. medical science. 

Evidently, Hank s letter did not arrive in time to influence the promotion board. On the very day of his retirement ceremony, a different letter was en route from Brigadier General Thomas Whelan, Special Assistant to the Surgeon General for Medical Affairs. It offered heartiest congratulations on my selection for promotion to Colonel in the Army of the United States. Fortunately, Hank s timing was not as precise as it had been when he was jogging. My promotion... 

As a result of a number of enquiries to the Medical Affairs Department of the Association of the British Pharmaceutical Industry (ABPI) and the recognition that the media was being increasingly used to advertise for subjects for clinical trials, the ABPI Medical Committee set up a Task Group to develop these guidelines. 

Consulting Pharmaceutical Physician, formerly Corporate Medical Advisor, Corporate Department Medical Affairs, Boehringer Ingelheim, Ingelheim-am-Rhein, Germany... 

Clinical Development Medical Affairs, Neuroscience Novartis Pharma AG CH-4002 Basel Switzerland and... 

Aventis Pharma Deutschland GmbH Scientific Medical Affairs,... 

A summary for all customer complaints based on Customer Complaints Report written by QA, medical affairs, or drug safety. 

Norman W. Barton, M.D.. Ph.D. Vice President, Medical Affairs, Biotechnology General Corporation, Iselin, New Jersey... 

The GSK document addressed two studies In Study 329, paroxetine was no more effective than placebo, and in Study 377, placebo was actually better than paroxetine. The Central Medical Affairs team then explained that Study 329 would be published as an abstract (summary), but it would be unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine. ... 

Many doctors say that the reps do come up with nuggets of news worth listening to. While it may have been slanted, you could take away some information that would keep you up-to-date, says Dr. Michael Delman, the senior vice president of medical affairs at Southside Hospital in Long Island, New York, who spent a quarter of a century in private practice in internal medicine, gastroenterology, and addiction. 

The doctors make us do it. After all, the doctors could just say no—and some claim they do. A muckraking web site, nofreelunch.org, was started in 1999. Medical students at several universities launched boycotts of sales-rep pizzas and pens. Dr. Delman, the medical affairs vice president in Long Island, says he has never been on a drug company outing and doesn t even go to the supposedly educational dinners. 

If a request for information is solicited, then the company must stay within labeling in responding. If a request is totally unsolicited, then questions about off-label uses can be answered with information that is not restricted to approved label information. Companies can respond by providing research studies or other information. Generally, the medical affairs departments within companies handle responses to unsolicited requests for information. Companies usually keep records of such requests, and those records are subject to FDA inspection. If off-label information is sent to the requester, then the cover letter must make clear that the FDA does not approve the indication. 

Jasmina Mircheva, MD, PhD, received her medical degree from the Medical Academy in Sofia. She also has a PhD in experimental oncoimmunology. Dr. Mircheva has been the Director for Medical Affairs for Central and Eastern Europe for the European Proprietary Medicines Manufacturers Association (AESGP) in Brussels since June 1998. Previously, Dr. Mircheva had been ciffiliated with the National... 

Post-market approval medical affairs This involves the promotion of each product by marketing and sales functions and the oversight of this process by pharmaceutical physicians. Two other critical post-marketing components are as... 

The role of the clinician working in the OTC division of a major pharmaceutical company is substantially different from that played in the research or medical affairs departments dealing with drugs intended for prescription. One might assume that OTC work is simpler and less involved than that related to prescription medications. In many ways, the opposite is true. 

This section covers the area that is typically termed Medical Affairs in pharmaceutical companies. The specific areas of knowledge and capability are described in the following chapters, but a few words on the less tangible aspects of this subspecialty might be offered here. 

Secondly, these diverse tasks bring diverse responsibilities. Very often, those working in Medical Affairs departments will find themselves in the... 

The best medical affairs specialists are those with long experience. Although these chapters contain a useful knowledge base, nothing can replace several years experience in the trenches of a vigorous Medical Affairs department. The role can be the most stimulating of any in the industry, and it suits well the versatile generalist. 

Medical Affairs divisions are usually fully capable research organizations housed within large pharmaceutical companies, that are comprised of medical, clinical and managerial staff (usually... 

Medical Affairs departments are frequently capable of conducting various types of clinical research. The type of research culminating in the further categorization of the efficacy and safety of a new medicine can take the route of conventional phase III clinical development, sometimes conducted by a Medical Affairs division, whereby a new indication is sought. Another approach is to perform necessary clinical trials and seek approval to promote features of benefit-risk that are supported by clinical data, with or without requesting change of registered label use. This phase of... 

Additional research efforts conducted at the Medical Affairs divisions of pharmaceutical companies include the study of Health Economics and Clinical Outcomes Research, which examines the effect of drugs on the cost of healthcare delivery, as... 

Another major function of the Medical Affairs department is that of providing information about a company s products. Their customers range from fellow healthcare professionals to the public and internal company clients. The frontline is usually comprised of nurses and registered pharmacists who respond to telephone and written requests for medical information about products, spanning clinical safety and efficacy questions. Companies often offer this service as needed and most can respond to clinical questions within 24 h of a request with specific and detailed information. A frequently asked question document is prepared to enhance rapidity of response. If this document does not provide the needed information, further research by Medical Information specialist, often in collaboration with internal clinical staff, is... 

This activity often described as The Medical and Social Conscience of a company largely resides in the Medical Affairs department. In most large -and medium-sized pharmaceutical companies this responsibility lies with Medical Affairs. The review of all materials, whether detail pieces provided in person to physicians in practice, slide sets for speakers on behalf of the company, general promotional material that is disseminated via print, radio, TV or web must be reviewed and approved by internal committees comprised of Medical Affairs staff, regulatory and legal personnel. In addition to the company review, this material must be sent to FDA at least by the first day of use. Review by FDA s DDMAC should be sought for TV advertisements. 

MSF officers are scientists with MD or PhD or PharmD qualifications. They are usually specialized in an area of research, and thus, are often experts in their own fields. Because they are usually Medical Affairs employees, they do not report to Sales and their job metrics are not determined by commercial success. The separation of Sales and MSF activities is important as otherwise would lead to regulatory and legal ramifications. 

Medical Affairs departments design valuable and often extremely creative trials that provide important later phase information about clinical research conducted with soon-to-be-marketed or already marketed drugs in regard to their relative efficacy compared to others of its class, new information concerning efficacy in related indications and additional safety and efficacy data that supplement the core data which led to original approval. Because the type of research conducted in this later phase is often in response to residual questions about safety as part of phase IV commitments agreed to upon original approval,... 

However, there is a widely expressed sentiment in Europe that the long and technical labels promulgated by FDA are unlikely to be read by the ordinary prescriber. Thus, European labeling aims for concise and well-balanced summary information. For this reason, European labels are usually more difficult to write than, say, American ones, and are much more likely to be debated among the physicians in a company s medical affairs department, and between the company and the regulatory authority on subjective, interpretative grounds. 

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