Pharmaceutical medicine 2010;

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Vanessa Cohen-Mun˜oz,1,2 Marlene Llo´piz-Avile´s,1,3 Fabia´n Llorens,4 Miguel Peniche5 and Julieta Vargas6 1 AMEIFAC, Mexico City, Mexico2 GlaxoSmithKline, Mexico City, Mexico3 Venn Life Sciences Ltd, Mexico City, Mexico4 Valeant Pharmaceuticals, Mexico City, Mexico5 Laboratorio Silane´s, Mexico City, Mexico6 Laboratorios Roche, Mexico City, Mexico Pharmaceutical Medicine is a scientific medical discipline concerned with the discovery, development, evaluation, registration, monitoring and medical aspects of the marketing of medicines for the benefit ofpatients and the public health. This discipline has gone through an important evolution on a worldwide scalein the last 50 years. However, in Mexico and Latin America, its development has been recent and verysatisfactory, both on an organizational level, as well as academically.
Pharmaceutical Medicine in Mexico has reached a level of development that must be reinforced and perfected for maintaining regional and global leadership. Mexico’s current level of development can bemeasured by the new empowerment of undergraduate and specialist educational programmes for thoseinterested in Pharmaceutical Medicine at both public and private universities. Mexico is the first country inLatin America to obtain official recognition and support by one of two most renowned upper education andpostgraduate institutions in the country. In addition, local associations, such as the Association of MedicalSpecialists in the Pharmaceutical Industry (Asociacio´n de Me´dicos Especialistas en la Industria Farma-ce´utica, A.C. [AMEIFAC]), have become major drivers for the development and growth of PharmaceuticalMedicine in Mexico by performing multiple activities of relevance to the discipline. Important examplesinclude the publishing of books and articles, organizing presentations, workshops, symposia and forums,and participating in both national and international conferences, such as the 6th Latin American Congresson Clinical Research held in Mexico City in 2009, and the 7th Latin American Congress on ClinicalResearch, which will be held in Sao Paolo, Brazil in late 2010. AMEIFAC also organizes important socialand educational events such as bi-monthly seminars, annual meetings and a biennial congress for the entirepharmaceutical and academic arena in Mexico. Topics such as pharmacoeconomics, sustainable develop-ment and fast-tracking oncology clinical trials are only some of the many topics covered during thesegatherings.
A new age of maturity and solidification of Pharmaceutical Medicine as a specialty and medical devel- opment realm in both Mexico and throughout the world is underway. Our growth and development willcontinue to flourish as Pharmaceutical Medicine gains increasing global recognition as a vital part of futuredrug, biotechnological and device development.
tific medical discipline concerned with the discovery, develop-ment, evaluation, registration, monitoring and medical aspects According to the definition accepted by international orga- of the marketing of medicines for the benefit of patients and the nizations, such as the International Federation of Associations public health.[1] The tremendous growth of drug research and of Pharmaceutical Physicians (IFAPP) and the Faculty of the increasing availability of new and effective remedies have Pharmaceutical Medicine at the Royal Colleges of Physicians changed the face of medicine. As stated by Burley and collea- of the UK, among others, Pharmaceutical Medicine is a scien- gues ‘‘Pharmaceutical Medicine occupies the area of common these early companies were managed by chemists and phar- macists, with barely a handful of physicians employed in the As history has shown, during the 19th century, Mexico became a free and independent nation, after fighting and living through internal wars and power struggles, as well as several foreign invasions. The origins of the chemical/pharmaceutical industryin Mexico dates back to around this time when Leopoldo Rı´ode la Loza started the industrial production of diverse chemicalproducts.
Fig. 1. Where does Pharmaceutical Medicine sit? At the end of the 19th century and beginning of the 20th, several important therapeutic discoveries were made, which in- ground between the medical profession, the pharmaceutical cluded the first vaccines, aspirin (acetylsalicylic acid) and peni- industry and government’’[2] (see figure 1).
cillin, the world was fighting World War I and Mexico was In the last 50 years, this discipline has gone through an im- again shaken by a series of battles and revolts comprising the portant evolution on a worldwide scale (see table I). Pharma- Mexican Revolution, which ended in 1920.[13] ceutical Medicine has, as its centre, the clinical testing of None of these events detained the discovery of insulin by medicines, translation of drugs into new therapies, safety and Frederick G. Banting and Charles H. Best, which was officially the well-being of research subjects in clinical trials, in addition announced on 14 November 1921 at the University of Toronto, to understanding the profiles of medicines and their benefit-risk ON, Canada.[14] Among those in the audience was Dr George Clowes, who worked in the research department at Eli Lilly.
In order to understand the current status of Pharmaceutical Medicine in Mexico, a review is required of the history andevolution of the discipline, the current role of the pharmaceuti- Table I. Milestones in Pharmaceutical Medicine[3] cal physician in the pharmaceutical industry and its surrounding environment, the state of education and training programmes First professional association formed – the UK-based Association of for the pharmaceutical physician, and the involvement of as- Medical Advisers in the Pharmaceutical Industry (now known as the sociations and organizations of pharmaceutical physicians in British Association of Pharmaceutical Physicians) the advancement and continuous growth of Pharmaceutical International Federation of Associations of Pharmaceutical Physicians formed; today, there are 28 national member associations First Diploma in Pharmaceutical Medicine offered by the Royal Colleges of Physicians of Edinburgh, Glasgow and England.
Postgraduate course in Pharmaceutical Medicine, University of 2. History and Evolution of Pharmaceutical Medicine Society of Pharmaceutical Medicine formed Pharmaceutical companies began to arise, primarily in Europe, Faculty of Pharmaceutical Medicine formed during the second half of the 19th century. Among the first were Master of Science in Pharmaceutical Medicine offered by the E. Merck in 1827, which expanded from a pharmacy trade to a research-based industrial company;[5] Boehringer Mannheim in American Academy of Pharmaceutical Physicians inaugurated in the 1859;[6,7] Bayer founded in Barmen, Germany by dye salesman US (now known as the Academy of Pharmaceutical Physicians and Friedrich Bayer and master dyer Johann Friedrich Weskott in Recognition of specialty in Mexico and Switzerland 1863;[8] Hoechst founded by Eugen Lucius also in 1863;[9] Schering founded by Ernst Schering and incorporated as ChemischeFabrik auf Actien in 1871;[10] Boehringer Ingelheim founded in International Federation of Associations of Pharmaceutical Physicians Council for Education in Pharmaceutical Medicine formed 1885 by Albert Boehringer in Ingelheim am Rhein;[11] Knoll founded in 1886 by Drs Albert Knoll and Hans Knoll;[12] andRoche founded in 1896. Other pharmaceutical companies fol- lowed, such as Eli Lilly, Abbott and Pfizer in the US. Most of Innovative Medicine Initiative PharmaTrain project launched ª 2010 Adis Data Information BV. All rights reserved.
This coincidental meeting led to Eli Lilly’s signing of a contract in Mexico, in addition to laboratories such as Laboratorios on 7 July 1922 for the manufacture of insulin, making it readily Fournier, Laboratorios MyN and Laboratorios Garde, among available to physicians and patients. This milestone is just one others, which used medical school students and occasionally example of what seems to have been the start of modern physicians for the marketing and distribution of their products.
This peaceful period was interrupted by the Spanish Civil The history of the production of medicines or remedies in War (July 1936 to April 1939) and, later, by World War II from Mexico is as old as the history of our country; however, it was September 1939 to August 1945. After the war, there was both not until 1916 that the School of Chemical Industries was national and worldwide social, political and economic read- founded – becoming part of the national university on 5 Feb- justment. During this time, several new pharmaceutical com- ruary 1917. Finally, in 1919, the Pharmaceutical Chemist career panies settled in Mexico, while others were returned to their became part of the School of Chemistry curriculum.[15] rightful owners by the Mexican government who had secured In Mexico, during the first quarter of the 20th century, the use of medicines was based on the availability of official, Galen In the 1950s and 1960s, there was the intermingling of basic and magisterial preparations with all active principals imported and clinical research, which led to an important advance in from Europe and the US. The massive demand for those drugs medical research in Mexico. To date, there are well established led to the development of industrial pharmacy with the emer- clinical centres. There are also reference hospitals and institu- gence of companies such as Schering, Merck, Bristol, Sterling tions where clinical research is conducted.[16] Drugs, Parke Davis and Hoffman-La Roche, among others. All Starting in 1967, at the Italian pharmaceutical company of these large companies established branches in Mexico, first Carlo Erba, a group of Italian and Spanish physicians who all for importing their products and later for manufacturing. To- worked in the pharmaceutical industry, would frequently wards the middle of the 20th century, production started in gather with the purpose of improving, supporting, sharing and Mexico, reaching new heights in the manufacturing and dis- commenting on general affairs that affected their work and that tribution of drugs throughout Latin America.
of the industry’s. This was a somewhat friendly gathering of In the 1940s, the most important global scientific develop- colleagues who decided to constitute an association. This was ment relating to healthcare took place in Mexico – the produc- not an easy task as while some of the directors or general tion of steroid hormones. Russell Marker found plants in managers from the pharmaceutical laboratories supported the tropical areas in Mexico that served as the precursors for all idea, the majority were indifferent to it. Others, fortunately the steroid hormones: corticosteroids, progesterone, estrogens and minority, scorned the idea, often repeating the phrase ‘‘a medi- androgens.[15] Their widespread distribution throughout Mexico cal director is an unnecessary disease of the industry.’’ However, (i.e. Veracruz, Oaxaca, Chiapas and Tabasco) united inter- on 22 December 1967, before a public notary, the constitutive disciplinary scientific groups to gather together to develop the act of the Association of Medical Directors of the Pharma- technology necessary for the industrial production of a range of ceutical Industry (Asociacio´n de Directores Me´dicos de la steroids. At the same time, groups of physicians and pharma- Industria Farmace´utica, A.C. [ADIMED]) was signed and cologists began conducting the necessary clinical trials to de- its first president, Dr Jose´ Urbano Blanchet, was appointed, monstrate the efficacy and safety of drugs containing steroid to launch and serve Pharmaceutical Medicine in Mexico.[20] hormones for the treatment of diseases that had been difficult to The role of the physician in the pharmaceutical industry at this time was not particularly enviable. It was regarded as Clinical research in Mexico in its true sense is said to have ‘low status’ and such doctors were not well received by their started with the creation of the Mexican National Institutes of clinical colleagues who referred to them as ‘‘failed physicians,’’ Health,[16] which comprised Mexico’s Children’s Hospital ‘‘only good for signing cheques’’ and as ‘‘having sold out to the (Hospital Infantil de Me´xico)[17] and the Institute of Cardiology and Nutrition (Instituto de Cardiologı´a y Nutricio´n).[18] Other It was not long before ADIMED showed that it was ex- institutions became involved in the following 10 years such as tremely useful by convincing Mexican health and sanitary au- the Mexican Institute of Social Security (Instituto Mexicano del thorities not to cancel the registration of several commonly Seguro Social),[19] followed by the General Hospital of Mexico used products, for example, anti-inflammatory enzymes, which were later substituted by NSAIDs; phenformin, which was later Before World War II, other important pharmaceutical firms sold in combination with a sulfonylurea; and high-dose vitamin and pharmacies, such as Alexander Rueff and Sanborns, settled ª 2010 Adis Data Information BV. All rights reserved.
Opinion on physicians working in the pharmaceutical Table II. Components of Pharmaceutical Medicine industry started to change for the better when these doctors promoted the research of new drugs in collaboration with This association evolved and improved over time. During the presidency of Dr. Germa´n Novoa Heckel, the statutes and the name of the association changed with the signing of the constitutive act on 14 September 1992 – its new name being the Association of Medical Specialists in the Pharmaceutical Industry (Asociacio´n de Me´dicos Especialistas en la Industria Throughout the years, AMEIFAC has added several spe- cialists in Pharmaceutical Medicine. Some of the professors ofthe specialty have published the following books: patients; those to whom all pharmaceutical developments are  Good Clinical Practice in Mexico (Buenas Pra´cticas Clı´nica directed. Some of their inherent responsibilities include (i) to act en Me´xico), in collaboration with the Mexican Association as the conscience of the company; (ii) to ensure guidelines and legal requirements are followed; (iii) to contribute to the med-  Practical Guidelines in Pharmaceutical Medicine (Guı´as ical aspects of product development; and (iv) to support both Pra´cticas en Medicina Farmace´utica)[22] medical and non-medical departments for marketing purposes.
 Manual of Ethics and Regulation in Clinical Research Of course, all physicians involved in this field must provide the (Manual de Etica y Regulacio´n en la Investigacio´n Clı´nica).
‘medical expertise’ required and when necessary, act as a point Based on a conversation during the International Con- of contact with the professional Mexican medical sectors.
ference on Pharmaceutical Medicine (ICPM), which is orga- The pharmaceutical physician could practice in the medical nized by IFAPP in collaboration with a local national member area at pharmaceutical companies and be involved in writing association, the idea arose to hold the meeting in Mexico and and authorizing standard operating procedures, predominantly the Council of Former Presidents decided to enthusiastically those related to clinical trials and good clinical practice. In the pursue this goal. In 2002, Mexico was given the honour of clinical arena, the pharmaceutical physician may also carry out hosting the 12th ICPM in Cancu´n, with a representation of clinical trials in defined therapeutic areas and in this manner, 27 countries. This meeting was the first ICPM of the millen- maintain contact with key opinion leaders. Physicians may also nium, the second to be held in a Spanish-speaking country and update, gather and store information from clinical trials. The the first in Latin America. The conference title, ‘The Future is physician, serving as a statistician, may suggest modifications Now’, was a touchstone for debate on contributions of accel- to the design of clinical trials, make suggestions regarding data erating development on many fronts to realize a global medi- analysis or participate in the interpretation of results.
cines industry. Four themes stood out to measure this progress Maybe one of the most important contributions made by as follows: regulatory harmonization; the applicability of uni- pharmaceutical physicians is in the pharmacovigilance area, where versal bioethical principles; the application of electronic media the responsibility of the physician includes actively monitoring to data management and clinical trials conduct; and the em- the safety of both experimental and licensed drugs and devices, bracing of new opportunities for medicines from biotechnology developing ‘Dear Doctor’ letters, communicating with regula- tory authorities, and being actively involved in circumstancesimplicit in a recall or product withdrawal.
One of the other functions in which the pharmaceutical 3. The Current Role of the Pharmaceutical Physician in physician could participate in is the medical information area.
the Pharmaceutical Industry and its Surrounding Physicians may contribute as a scientific consultant, providingspecialized information on a product or a specific therapeutic area. Some pharmaceutical physicians provide scientific services, Physicians in Mexico working in the pharmaceutical indus- providing information to the outside world. These functions try may play many roles and have diverse responsibilities (see have the implicit following of requests for information that may table II). However, their priority and main focus should be the ª 2010 Adis Data Information BV. All rights reserved.
In the regulatory area, the pharmaceutical physician is in local and international regulatory concepts, scientific writing charge of defining the content of the dossier, deciding on the and the necessary abilities in clinical research. In addition, pharmaceutical, toxicological and clinical data required to de- administrative skills are required, along with a proficiency in monstrate the quality, safety and efficacy of the product for leadership, marketing, communication and training techniques marketing authorization. This implies that a constant update on national and international regulations should take place, Undergraduate university training starts with an introduc- while establishing adequate communication within the com- tory review of Pharmaceutical Medicine focused on clinical pany and, if necessary, commenting on proposals presented by research and bioequivalence. Without a doubt, a determining the regulatory authorities to other associations. Additionally, factor in preparing pharmaceutical physicians is for them to be the pharmaceutical physician can be responsible for submis- trained early on in their careers. However, medical schools in sions related to clinical trials and ensuring that the promotional Mexico do not usually include courses on clinical research and material is in agreement with the rules and regulations necess- bioequivalence. It is estimated that <1% of graduates go on to work in the pharmaceutical industry. This of course does not Finally, as a result of the increase in costs in healthcare, it is justify increasing or emphasizing training in this field. How- now necessary to assess the economic benefits of a new drug in ever, it is unclear whether such pharmaceutical concepts are addition to demonstrating the traditional efficacy, safety and useful not only for those entering the pharmaceutical industry, tolerability measures. There is the need for pharmaceutical but also for all physicians, including clinicians.
physicians to assist in these activities.
Specialist programmes offer physicians the key skills required When considering the different areas of participation of the to make them valuable resources for pharmaceutical compa- pharmaceutical physician, it is clear that interaction with other nies, contract research organizations, sanitary agencies and members of the medical department, as well as with colleagues research and medical care units. If the training of a physician, from other areas such as marketing, legal and communication, both as a general practitioner and as a specialist, includes a is required. One of the most valued contributions of the phar- background in pharmacology, pharmacovigilance, epidemiol- maceutical physician is their opinion on the clinical benefit and ogy, statistics and clinical research principles, then doctors will the commercial potential of a drug, in addition to knowing how be well prepared to actively contribute in any of these areas. It is to best position it from a commercial standpoint.
of much more value that a physician intending to work in the In order to carry out issue management, the ideal situation is pharmaceutical industry undertake specialized training in such to participate early in the event in order to identify and docu- key areas and that they update their knowledge of therapeutics.
ment the valid data and to prepare arguments and responses to As a result, there is a need for educational programmes in the potential questions. Prior training that incorporates certain this field. An example of this is the Faculty of Pharmaceutical management skills may be useful in communicating with the Medicine in the UK through the Royal Colleges of Medicine.
media and general public. It goes without saying that the In the 1990s, there were several, robust educational pro- pharmaceutical physician should also be trained in effective grammes, available mainly in Europe; however, these courses presentations to serve as an ambassador for the company.
had yet to gain recognition as a medical specialty, except in the In addition to the key functions described in this section, pharmaceutical physicians who so desire may participate in anymarketing activity within a pharmaceutical company provided Bedside medicine, primary responsibility for 4. The State of Education for the Pharmaceutical Laboratory, investigational, indirect, supportive, cohort and population based, working for the benefit In the first instance, pharmaceutical physicians require a Medical science, disease, clinical, epidemiological, good medical and clinical education. This foundation is com- plemented with more specialized training in pharmacology, Students, healthcare professionals, juniors, others toxicology and drug safety, as well as a thorough grasp of good clinical practice, ethics, research methodology, monitoring, ª 2010 Adis Data Information BV. All rights reserved.
Table IV. Postgraduate courses in Pharmaceutical Medicine member of AMEIFAC, Dr Fabia´n Llorens, proposed toAMEIFAC’s Council of Former Presidents and Board Mem- bers that the course be set up instead at IPN. On 15 November 1999, approval for the specialty programme was published in the Institute’s gazette. In February 2000, the biannual pro- gramme began, which after assisting the demands of aspiring students for two generations, has now become an annual pro- gramme with its eighth class continuing in January 2010.[27,28] To date, over 140 students have graduated – many of whom went on to successful industry careers.
The programme has undergone changes as a result of mo- difications in the rules and regulations at the IPN. An example of this is a requirement established since 2006, where a thesisand a grade examination are now required to complete a spe- Philippines where the current programme is the first and only registered programme by a public university in the world (see In 2007, the programme was evaluated and validated by the IFAPP. An evaluating commission was sent to assess the Towards the end of the first decade of the 21st century, programme, validate the endorser, site and even attend classes.
several programmes were registered in several European coun- The programme is divided into four semesters and includes tries. However, most of them have not been officially recog- 15 courses and 3 seminars each year. It will soon be comple- nized by educational institutions of renowned prestige.
mented by an introductory course for those who have recently Other countries that have specialist programmes, but which graduated from a bachelor’s degree programme and who are are not recognized as such, are underway in Ireland, Switzerland interested in developing a career in the pharmaceutical industry.
and Belgium; this is surprising given the long history of Pharma- Among the subjects given in the first two semesters are phar- ceutical Medicine in these countries. France, Spain, Italy, Sweden, macology, pharmacokinetics, pharmacodynamics, pharmaco- Holland, Finland and Portugal are in the same situation.
epidemiology, pharmaceutical marketing, administration, writing Mexico was the first country to obtain official recognition of scientific documents, regulatory affairs, ethics and applied for Pharmaceutical Medicine as a listed medical specialty and to gain support by one of two upper education and postgrad- While considering specialization programmes, certain mono- uate institutions in the country. This official recognition is un- graphic and continuing education courses have been generated derlined by the availability of accredited education and training including the following topics or areas of interest: of specialist pharmaceutical physicians, the establishment and maintenance of standards of practice and professionalism in the competency, care and conduct applied to their work, and of growing public recognition and accountability. Argentina and Brazil are closely following Mexico’s steps – still without The idea of initiating a specialty programme in Pharma-  finance for non-finance personnel, etc.
ceutical Medicine at the Faculty of Medicine of the National A project to convert the specialty into a master degree pro- Autonomous University of Mexico (Universidad Nacional gramme is currently underway, with the support of an institu- Auto´noma de Me´xico [UNAM]), as a complement to the courses already offered there, was proposed and commissioned In addition to the educational courses described, AMEIFAC by the Council of Former Presidents.[25,26] After 6 years of has become directly associated with international organiza- trying, they were unable to achieve the start of the programme tions such as the Drug Information Association for carrying due to technical and political issues; however, the goal was not out events in Mexico on relevant topics such as regulatory af- forgotten. An alumnus from the Superior School of Medicine fairs, genomics and clinical research and, with the support and (Escuela Superior de Medicina [ESM]) of the National Poly- participation of foreign associations, has had some excellent technic Institute (Instituto Polite´cnico Nacional [IPN]) and a ª 2010 Adis Data Information BV. All rights reserved.
In the near future, there will be a programme of courses Consultants of the Argentinean Pharmaceutical Industry (As- online at the Edufarm e-learning website that is progressing ociacio´n de Me´dicos Asesores de la Industria Farmace´utica towards and allowing for integral leadership in Mexico in this Argentina [AMAIFA]) and Brazilian Society of Pharmaceu- tical Medicine (Sociedade Brasileira de Medicina Farmaceˆutica[SBMF]), among others.
Other organizations within the pharmaceutical realm, such 5. Associations and Organizations of Pharmaceutical as the National Association of Executives in Sales of the Phar-maceutical Industry (Asociacio´n Nacional de Ejecutivos de Ventas de la Industria Farmace´utica, A.C. [ANEVIFAC]) or When speaking on Pharmaceutical Medicine, we must not the Mexican Association of Pharmaceutical Laboratories (Aso- forget that the ADIMED came about 44 years ago, and, as ciacio´n Mexicana de Laboratorios Farmaceuticos [AMELAF]), mentioned in section 2, changed its name in 1992 to AMEIFAC.
have brought forward new objectives of interacting with other All of its members are physicians, a growing number of whom associations and the academic teams to expand and progres- are specialists in Pharmaceutical Medicine, since it became of- sively consolidate the concept of Pharmaceutical Medicine and ficially recognized as a medical specialty in 1999.
the tools it represents for the development and marketing of AMEIFAC has become the main driver of development for products in a market that is increasingly complex and competitive.
Pharmaceutical Medicine in our country and is recognized byimportant national organizations such as the National Cham-ber of the Pharmaceutical Industry (Ca´mara Nacional de la Industria Farmace´utica [CANIFARMA]) and the Ministry of Pharmaceutical Medicine in Mexico has reached an optimum Health. On an international scale, AMEIFAC is affiliated to level of development that must be reinforced and perfected for maintaining regional and global leadership. We are currently at Pharmaceutical Medicine in Mexico, as in the rest of the world, a stage in strengthening contributions in lieu of the betterment is based on the principles of medical ethics and the universal of health and the improvement of patient lives.
codes of truth, transparency and trustworthiness. Pharmaceu- For companies, having adequately trained pharmaceutical tical physicians conduct themselves with the highest standards physicians on their staff confers the best perspectives possible of honesty, trustworthiness, integrity and professionalism, in for the development and marketing of their products. A pharma- search of loyalty to our industry, patients and society in general, ceutical physician improves the success of research program- and maintaining the highest scientific standards within a hu- mes, optimizes the utilization and productivity of the available manistic framework and social consciousness.
resources and facilitates the acceptance of publications in high- The association has created ties with other national and international groups, including: the Mexican Association of We are currently living in a new age of maturity and solidifi- Pharmacology (Asociacio´n Mexicana de Farmacologı´a A.C.
cation of Pharmaceutical Medicine as a specialty. The continued [AMEFAR]), the Mexican Pharmaceutical Association (Aso- growth of this specialty will allow for further merging of the ciacio´n Filoso´fica de Me´xico [AFMV]), CANIFARMA, the medical profession, the pharmaceutical industry and govern- Ethics and Transparency Council of the Pharmaceutical Indus- ments in search of new drugs and cures for common and newly try (Consejo de E´tica y Transparencia de la Ca´mara de la Indus- discovered therapeutic indications, both in the short term and tria Farmace´utica [CETIFARMA]), the Mexican Association of Pharmaceutical Research Industries (Asociacio´n Mexicanade Industrias de Investigacio´n Farmace´utica, A.C. [AMIIF]),the National Association of Drug Manufacturers (Asociacio´n Nacional de Fabricantes de Medicamentos, A.C [ANAFAM]),the Mexican Association of Pharmacovigilance (Asociacio´n The authors are grateful to Dr Juan Lahuerta, MD, PhD, FFPM at the Mexicana de Farmacovigilancia [AMF]), the National Acad- Medical Department, GSK, Spain, and Chairman of the Council forEducation in Pharmaceutical Medicine (CEPM). The authors are also in emy of Medicine (Academia Nacional de Medicina [ANM]), debt to the International Federation of Associations of Pharmaceutical the Federal Commission for the Protection against Sanitary Physicians (IFAPP) for the information provided, allowing them to place Risks (Comisio´n Federal para la Proteccio´n contra Riesgos Mexico in the context of global Pharmaceutical Medicine, and would like Sanitarios [COFEPRIS]), IFAAP, the Association of Medical to express their thanks to Dr Peter D. Stonier, Director of Education and ª 2010 Adis Data Information BV. All rights reserved.
Training at the Faculty of Pharmaceutical Medicine, Royal Colleges of 12. History of Knoll Pharmaceuticals [online]. Available from URL: http://www.
Physicians in the UK for his unconditional support in the development of the specialty in Mexico and the academic activities, as well as the Inter- national Conference on Pharmaceutical Medicine (ICPM) in Cancu´n, 13. Plascencia-Garcı´a M. La Industria Farmace´utica en Me´xico. Bol Soc Quim Mexico in 2002. And finally, the authors would like to express their sinceregratitude to Dr Germa´n Novoa for providing all reference sources for the 14. Discovery of Insulin. The discovery of insulin: a Canadian medical miracle of the 20th century [online]. Available at URL: http://www.discoveryofinsulin.
Vanessa Cohen-Mun˜oz is the Board of Director’s President for 15. Islas-Pe´rez V, Sa´nchez-Ruiz JF. Breve historia de la farmacia en Me´xico y el AMEIFAC and Medical Manager at GlaxoSmithKline, Mexico; Marlene Mundo. Mexico City: Asociacio´n Farmace´utica Mexicana, 1992 Llo´piz-Avile´s is the Board of Director’s Secretary for AMEIFAC and 16. Compendium of clinical research in Latin America. First national meeting of Regional Director for Latin America at Venn Life Sciences Ltd; Fabia´n the Association of Medical Specialists in the Pharmaceutical Industry: Llorens is the Regulatory Affairs and New Products Director for Mexico, AMEIFAC February 1993. Mexico City: Intersystem SA de CV 1993; S.A. de Central America, Caribbean and the Andine Region at Valeant Pharma- ceuticals, the Coordinator of the Pharmaceutical Medicine Specialties 17. History of Hospital Infantil de Me´xico [online]. Available from URL: http:// Programme and previously served as president of AMEIFAC; Miguel [Accessed 2010 Jun 28] Peniche is a Consultant to the Presidency at Laboratorio Silane´s and 18. History of Instituto de Cardiologı´a [online]. Available from URL: https:// previously served as president of AMEIFAC; and Julieta Vargas is the [Accessed2010 Jun 28] Board of Director’s Vice President for AMEIFAC and Director of Cor-porative Affairs at Laboratorios Roche.
19. History of the Instituto Mexicano del Seguro Social [online]. Available from URL: [Accessed The authors have no conflicts of interest that are directly relevant to the content of this review. No sources of funding were used to assist in the 20. Novoa G, Ramı´rez J, Ruiz J, et al. Asociacio´n de Me´dicos Especialistas en la Industria Farmace´utica, A.C.: pasado presente y futuro. 2nd ed. Mexico City:AMEIFAC, 2005 Nov 21. History of AMEIFAC [online]. Available from URL: http://www.ameifac. [Accessed 2010 Jun 28] 1. Pharmaceutical Medicine. Specialties: Royal College of Physicians [online].
22. Llorens F, Martı´nez P, Novoa G. Guı´as Pra´cticas en Medicina Farmace´utica.
Available from URL: 1st ed. Mexico City: Ciencia y Cultura Latinoame´rica, 2001 Medicine/Pages/Pharmaceutical-Medicine.aspx [Accessed 2010 Jun 28] 23. International Federation of Associations of Pharmaceutical Physicians [on- 2. Burley DM, Clarke JM, Lasgna L, editors. Pharmaceutical medicine. 2nd ed.
line]. Available from URL: [Accessed 2010 Jun 28] 24. Novoa G. El Me´dico Farmace´utico: una nueva especialidad en desarrollo.
3. Griffin JP, O’Grady J, Wells FO, editors. The textbook of pharmaceutical medi- Medicina Interna de Me´xico 1998 Sep-Oct; 14: 240-2 cine. 2nd ed. Belfast: W and G Baird, Ltd and the The Queen’s University ofBelfast, 1994 25. UNAM. Diploma in clinical monitoring [online]. Available at URL: http:// [Accessed 2010 4. Stonier PD, Silva H, Lahon H. Pharmaceutical medicine: history, global status, evolution and development. Int J Pharmaceut Med 2007; 21 (4): 253-62 26. UNAM. Diploma in pharmacology [online]. Available from URL: http:// 5. The Merck Group. History [online]. Available from URL: http://www.merck. [Accessed 2010 de/en/company/history/history.html [Accessed 2010 Jun 28] 6. Pizzi RA. Memories of Mannheim. Modern Drug Discovery 2004 Apr; 7 (4): 27. Instituto Polite´cnico Nacional. Pharmaceutical medicine specialty program [online]. Available from URL: 7. Fischer EP. Selling science: the history of Boehringer Mannheim. Mannheim: IPN_HOME/IPN/ESTRUCTURA_PRINCIPAL/OFERTA_EDUCATIVA/ ESPECIALIDAD_POSGRADO_/PRESENCIAL/TITULOACADEMICO_ESM_ESPECI_ME_2.HTM [Accessed 2010 Jun 28] 8. Bayer. Bayer history: the early years [online]. Available from URL: http://www. [Accessed 2010 Jun 28] 28. Lyght CE. The role of the medical director in the pharmaceutical industry. Curr 9. Hoechst company history [online]. Available from URL:[Accessed 2010 Jun 28] 10. Schering company history [online]. Available from URL:[Accessed 2010 Jun 28] Departamento 302 B, Colonia General Anaya, CP: 03340, Me´xico D.F., 11. Boehringer Ingelheim. Corporate profile [online]. Available from URL: http:// [Accessed 2010 ª 2010 Adis Data Information BV. All rights reserved.


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Studium generale: Projekt © Herausgeber: Prof. Dr. med. Bernd Fischer Gehirndoping für alle? Gehirndoping für alle? In Kooperation mit Memory-Liga Zell a. H., Verband der Gehirntrainer Deutschlands VGD®, Wissiomed®-Akademie Die Unterlagen dürfen in unveränderter Form unter Angabe des Herausgebers in nicht kommerzieller Weise verwendet werden! Wir sind dankbar für Veränderungsv

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