President’s Letter

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K E E P I N T O U C H W I T H I F A P P • W W W. I F A P P . O R G III·2007·DECEMBER

Dear Colleagues

During IFAPP’s face-to-face October ExecutiveCommittee meeting inLondon, we reviewed ourachievements, analyzedongoing initiatives and discussed our futureplans. Delegates from ten countries and twoco-opted members were present. Specifically,we developed a draft for IFAPP’s future Strate-gic Plan, which will be discussed at the nextmeeting; we reviewed the financial figures for2007 and estimates for 2008, updated theICPM 2008 strategy and determined the‘Ethics Working Group’ perspectives.

On 19 October, the 9th IFAPP EuropeanConference took place, organized in collabora-tion with the ‘British Association of Pharma-ceutical Physicians’ (BrAPP). The excellentspeakers focused on “The Impact of the EUDirective on Clinical Trials” in the morning ses-sion and on “The Emerging Role of Europe inPediatric Development” in the afternoon sessi-on. A total of 40 enthusiastic attendees tookan active, participating role during the confe-rence. � page 2

Questions & Answers

Questions & Answers

Set up the ‘Chinese Society of Pharmaceutical Medicine’ 1+3

Reports & Concepts

IFAPP at the 8th EACPT Conference 5

Bioethics – a Global Challenge 7

PM Training Proposal Passes First Filter of the European ‘Innovative Medicines Initiative’ 9

Global Initiatives of Clinical Research in Latin America 10

Personal Snapshot

Dr Stewart Geary Decorated withDIA’s ‘Outstanding Service Award’ 4+5

IFAPP Interactive: Please Respond

Short Tutorial in Ethical Conduct Decision-Making 6

News from IFAPP’s CEPM

Education in Pharmaceutical Medicine – an Update 8

IFAPP’s Regional Update: Spain

Drug Safety: Particularities in Spain 12

CONTENT

I nternational

F ederation of

A ssociations of

P harmaceutical

P hysicians

Set up the ‘Chinese Society of Pharmaceutical Medicine’

The ‘First Chinese Conference on Pharma-ceutical Medicine’ (CCPM 2007) was held inBeijing on 18-20 October 2007 and was both amilestone event and huge success, as Dr FrankFan, Representative and Co-Founder of the‘Chinese Pharmaceutical Medicine Forum’(CPMF) reports on page 2. What is the ideabehind CCPM 2007, what was the plan andwhat is the perspective? Dr Fan has answeredthese questions in a conversation with EckhardBoettcher-Buehler from IFAPP World.

IFAPP World • Dr Fan, you and the otherorganizers obviously raised intense interest withCCPM 2007 – congratulations. Was it purelyparticipants’ interest in conference program

Dr Luis F. Collia, IFAPP President

ICPM 2008 in AmsterdamDeveloping PharmaceuticalCare – Medicines After the Blockbuster Era

Just nine months to go before the openingof the next ‘International Conference on Phar-maceutical Medicine 2008’ in Amsterdam, theNetherlands, 7-10 September 2008! Registra-tion is open now at www.icpm2008.org whereyou also will find the latest news, the most up-to-date scientific program, call for abstractdetails and accommodation information aswell as social activities during the conference.

Why should you come to the ICPM 2008 in Amsterdam?

This conference is your biannual ‘vaccinati-on’ to enrich your practical knowledge on dif-ferent key topics in Pharmaceutical Medicine –this conference is specifically designed toaddress all of the related aspects in our currentchanging environment. For scientists and col-leagues working in the clinical operations fieldthere also is an interesting parallel programwhich takes as a starting point the overall con-gress theme “Developing � page 2

IFAPP’s Calendar

Dr Frank Fan: “Thanks to theactive support and encoura-gement from both CMA andIFAPP, the first ‘Chinese Con-ference of PharmaceuticalMedicine’ (CCPM 2007) successfully became a truemilestone for Pharmaceutical Medicine in China.”

content or were they also interested in the planto establish a ‘Chinese Society of Pharmaceuti-cal Medicine’?

Dr Frank Fan • China is becoming one of themost dynamic pharmaceutical markets in theworld. Both, multinational pharmaceuticalcompanies and local start-up life science bio-tech companies are setting up or expandingtheir research and development facilities inChina.

The number of physicians joining the phar-maceutical industry has been increasing dra-matically in the past few years. They are invol-ved in almost all activities concerning Pharma-ceutical Medicine, such as � page 3

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2III·2007·DECEMBER

President’s Letter

� page 1 Another importantmeeting was held at the sametime on the other side of the glo-be: the first ‘Chinese Conferenceon Pharmaceutical Medicine’,Beijing, China, 18-20 October 2007. IFAPP wasrepresented by Professor Jean-Paul Deslyperefrom Singapore, Professor Gerfried Nell fromAustria, and Professor Peter Stonier from theUnited Kingdom. As Dr Frank Fan, Representa-tive of the ‘Chinese Pharmaceutical MedicineForum’ (CPMF) reports on this page, the confe-rence had more than 400 attentive and enthu-siastic participants, most of them physiciansand experts in Pharmaceutical Medicine. AsProfessor Nell confirmed, the program coveredthe whole area of Pharmaceutical Medicinewith lectures of the highest international stan-dard. Details on the initiative to set up the‘Chinese Society of Pharmaceutical Medicine’you can find in an interview with Dr Fan,beginning on the previous page.

During my European tour prior to the 9thIFAPP European Conference, I met ExecutiveCommittee (EC) members of different nationalmember associations (nMAs) in London at theconference venue and in Paris and Budapest.These individual meetings with colleagueshave strengthened the relationship betweenIFAPP and nMAs. I would like to thank all whoattended and made these meetings possible;

First ‘Chinese Conference on Pharmaceutical Medicine’: a Milestone EventDr Frank Fan, Representative and Co-Founder of the ‘Chinese Pharmaceutical Medicine Forum’ (CPMF), Beijing, China

China • The first ‘Chinese Conference onPharmaceutical Medicine’ (CCPM 2007), heldin Beijing on 18-20 October 2007, was a mile-stone event and big success. Its key focus wasto promote Pharmaceutical Medicine as amedical specialty in China.

Since the late 1980s, China has emerged asa dynamic pharmaceutical market. Many globalR&D based pharmaceutical companies startedsetting up their affiliate operations in China,and increasingly medical doctors have beenjoining the pharmaceutical industry in thefields of clinical research, medical affairs,regulatory affairs and pharmacovigilance.Overall, Pharmaceutical Medicine is recognizedin China progressively more as a medical speci-alty.

CCPM 2007 was jointly organized by the‘Chinese Medical Association’ (CMA), the ‘Chi-nese Pharmaceutical Association’ (CPA) and

the ‘Chinese Pharmaceutical Medicine Forum’(CPMF) in collaboration with IFAPP. Its pro-gram was diverse and in-depth, covering mostaspects of Pharmaceutical Medicine and inclu-

ding 10 themes, 33 presentations, four featu-red seminars, three panel discussions and apre-conference workshop on clinical researchmethodologies. � page 3

thank you for your support and hospitality. Ihope to meet EC members from other countriesin the future in order to learn more from theiropinions and suggestions that would benefitIFAPP as a global network. All of you are kind-ly invited to work with the EC in regional andinternational tasks, in order to reach IFAPP’sobjectives and to get the recognition and visi-bility that we seek.

With regard to ICPM 2008, you already canregister for the event, send abstracts and bookhotels and tours. A preliminary program isavailable at www.icpm2008.org and you willsoon find it completed with names of thechairmen and speakers. With regard to ICPM2010, I invite you all to analyze the possibili-ty of your region hosting this important eventand of course, if you decide to take this chal-lenge, please send a proposal to IFAPP’s secre-tariat (ifapp@planet.nl).

Last but not least, it is my pleasure to con-gratulate the newly elected presidents of theAustralian Society, Dr Leanne Wall, and of theSpanish Society, Dr José Maria Giménez-Arnau,who recently assumed these positions. Finally,I thank all of you for your active participationin IFAPP’s operations and wish you all a HappyNew Year 2008!

Dr Luis Francisco Collia, IFAPP President,Medical Manager Merck Serono Argentina,Buenos Aires, Argentina �

� page 1 Pharmaceutical Care;Medicines after the BlockbusterEra.”

In addition to the scientific pro-gram, there will be three parallel‘executive training modules’ (freeof extra charge!) during the mor-ning session: 1. Statistics for non-interventionstudies, 2. Update in risk management plan-ning, 3. Media training for pharma executives.You can click the button on your online regis-tration form to have a chance to participate inthese executive classes! As there is limitedcapacity, participation is on a first-come basisthrough online registration and payment.

As well as the scientific program, there willbe an interesting Welcome Reception in theRijksmuseum and an unforgettable Dutch GalaDinner in the Beurs of Berlage. All activitiestake place around the center of Amsterdam.

Dr Rudolf van Olden, Member of IFAPP’s Exe-cutive Committee, Chairperson ICPM 2008 onbehalf of the local organizing and scientificcommittee �

IFAPP’s Calendar

Reports & Concepts

Join ICPM 2008 in Amsterdam!

The CCPM 2007 Organizing Committee and guests at the closing ceremony

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� page 2Representatives from

the Chinese ‘Ministry ofHealth’ (MOH) and the‘State Food and DrugAdministration’ (SFDA),from CMA and CPA attended the conference. MrZhang Wei, Head of SFDA’s department for drugregistration, presented a keynote lecture on the development of innovative pharmaceuti-cals in China. Professor Gerfried Nell fromAustria, delegate and President Elect of IFAPP,introduced IFAPP’s mission and vision in the21st century. While Professor Peter Stonierfrom the United Kingdom, Director of Educati-on & Training of the ‘Faculty of PharmaceuticalMedicine of the Royal Colleges of Physicians ofthe United Kingdom,’ gave a keynote lecture onPharmaceutical Medicine as a medical special-ty. Professor Jean-Paul Deslypere from Singa-pore, Chairman of IFAPP’s ‘Council for Educati-on in Pharmaceutical Medicine’ (CEPM), gave alecture on the development of PharmaceuticalMedicine in the Asia-Pacific region. Dr FrankFan, representative of CPMF, introduced thestatus and vision of setting up PharmaceuticalMedicine as a medical specialty in China.

The conference was well attended by morethan 400 professionals coming from multina-tional and local pharmaceutical companies,contract research organizations, hospitals,academic institutions and regulatory agencies.

The conference closing plenary session cul-minated in a lecture by Professor Gerfried Nellon the career development of pharmaceuticalphysicians, which raised a lot of positive feed-back from the attendees.

During the conference, delegates fromIFAPP – Nell, Stonier and Deslypere – had mee-tings with the delegates from CMA and CPMF,discussing the perspective of setting up the‘Chinese Society of Pharmaceutical Medicine’ inthe near future. �

Reports & Concepts

� page 1 exploratorydevelopment, clinical tri-als, post-marketing stu-dies, pharmacovigilance,medical marketing andpharmacoeconomics, andso on. PharmaceuticalMedicine has become anoften-mentioned topic among the pharmaceu-tical R&D professionals, however it is far frombeing officially and widely recognized as adistinct medical specialty in China.

In 2003, a group of physicians working inthe pharmaceutical R&D departments in multi-national pharmaceutical companies formed anorganization named ‘Chinese PharmaceuticalMedicine Forum’ (CPMF) to promote Pharma-ceutical Medicine as a medical specialty. In thepast four years, with energetic support fromthe ‘Chinese Medical Association’ (CMA), anofficial national organization of professionalsin the field of medical science, CPMF hasorganized various conference and seminars,published newsletters and collaborated withother academic organizations to both enhancePharmaceutical Medicine and improve the visi-bility and influence of pharmaceutical physici-ans in China.

Thanks to the active support and encoura-gement from both CMA and IFAPP, the first‘Chinese Conference of Pharmaceutical Medici-ne’ (CCPM 2007) successfully became a truemilestone for Pharmaceutical Medicine inChina. Pharmaceutical Medicine is now beingknown and understood by more and more phar-maceutical R&D professionals as a medical spe-cialty. As agreed by the CMA leaders, the pro-cess of establishing the ‘Chinese Society ofPharmaceutical Medicine’ has started.

IFAPP World • Regarding your Pharma-ceutical Medicine initiative in China: Whatactions do you plan on national and internatio-nal levels?

Dr Frank Fan • Although widely known as aninterlink subject between clinical medicineand pharmaceutical science, PharmaceuticalMedicine has not yet been recognized official-ly by the academics and regulatory authoritiesas a distinct medical specialty in China. Cur-rently there is no official postgraduate educa-tional program for Pharmaceutical Medicinehere. Following the successful CCPM 2007, wewill be working with CMA and IFAPP to set upthe CME/CPD schemes to improve the trainingand education of pharmaceutical physicians,based on the guidance of IFAPP’s ‘Council forEducation in Pharmaceutical Medicine’ (CEPM),as the first step in the short term. For the nextstep in the medium and long term we will try tocollaborate with medical and pharmacy schools

to initiate a Postgraduate Course of Pharma-ceutical Medicine.

In addition, there are a lot more initiativesin our minds; the key activities will include:� Organize scientific conferences and semi-

nars on a variety of issues concerning thediscovery and development of pharmaceuti-cals, vaccines, medical devices and diagno-stics.

� Publish newsletters and academic journalsin the filed of Pharmaceutical Medicine.

� Improve the collaborations with other medi-cal specialty societies and associations.We also are planning to host the ‘Interna-

tional Conference of Pharmaceutical Medicine’(ICPM) in China in the near future.

IFAPP World • Chinese experts in Pharma-ceutical Medicine obviously are well organizedalready and participate in several institutions:the ‘Chinese Medical Association’ (CMA), the‘Chinese Pharmaceutical Association’ (CPA) andthe ‘Chinese Pharmaceutical Medicine Forum’(CPMF). Could you briefly explain the diffe-rences between these organizations and howthey would relate to a prospected ‘ChineseSociety of Pharmaceutical Medicine’?

Dr Frank Fan • The ‘Chinese Medical Associa-tion’ (CMA), founded in 1915, is an officialorganization of physicians and medical scienceprofessionals. Under CMA, currently there are82 medical specialty societies, such as the ‘Chi-nese Society of Internal Medicine’, the ‘Chine-se Society of Clinical Oncology’, and so on.

The ‘Chinese Pharmaceutical Association’(CPA), founded in 1907, is an official organiza-tion of pharmaceutical scientists. Under CPA,currently there are 15 pharmaceutical special-ty societies, such as the ‘Society of Pharmaco-logy’, the ‘Society of Hospital Pharmacy’, andso on.

The ‘Chinese Pharmaceutical MedicineForum’ (CPMF), affiliated to CMA, is a prepara-tory body of the ‘Chinese Society of Pharma-ceutical Medicine’ (CSPM). Its members inclu-de pharmaceutical physicians and clinicalresearch professionals.

IFAPP World • What are the next stepstowards the ‘Chinese Society of PharmaceuticalMedicine’ and the recognition of PharmaceuticalMedicine as a medical specialty?

Dr Frank Fan • In the next few months wewill be working closely with the ‘Chinese Medi-cal Association’ (CMA) to set up the ‘ChineseSociety of Pharmaceutical Medicine’ (CSPM).Its mission is to promote the awareness, visi-bility and influence of Pharmaceutical Medici-ne as a distinct medical specialty and help ourpharmaceutical physicians to keep theirknowledge and skills up to date throughouttheir professional careers. CSPM membershipwill include the pharmaceutical physicians andclinical research professionals who spend the

majority of their time in matters related toPharmaceutical Medicine.

CSPM will be built on the current organiza-tion and membership of the already existing‘Chinese Pharmaceutical Medicine Forum’(CPMF) and will become one of the 80 acade-mic societies affiliated to CMA. Definitely,CSPM will apply to become member of IFAPP atthe appropriate time. We are looking forward tokeeping a close working collaboration withIFAPP and other national Pharmaceutical Medi-cine associations.

IFAPP World • Thank you very much. And allthe best for making your initiative a success! �

Questions & Answers

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Personal Snapshot

Dr Stewart Geary’s expertise in the fields ofpharmacovigilance, clinical safety and regula-tory science is in great demand international-ly. Recently in recognition of his work, hereceived the ‘Outstanding Service Award’ fromthe ‘Drug Information Association’ (DIA).Indeed, Dr Geary has provided and continues toprovide outstanding service through his excel-lent in-depth knowledge, giving valuable assi-stance to many international organizationsinvolved in Pharmaceutical Medicine.

Dr Geary modestly describes it as admittingone’s responsibility. Yet his concept of res-ponsibility extends beyond drug safety com-mon to the general public interest, to indivi-dual benefits for patients. Additionally, hisunique perspective includes intuitive globalthinking.

As recently announced in ‘DIA today,’ DrGeary is currently a member of the CIOMS VIIIWorking Group on Signal Detection, the DIAAdvisory Committee Japan, the Executive Com-mittees of the ‘Japanese Association of Phar-maceutical Medicine’ (JAPhMed) and IFAPPand the Regulations Advisory Board for theCMR International Institute for Regulatory Sci-ence, as well as on the Editorial Advisory Boardfor ‘Applied Clinical Trials’ (ACT). He previouslyserved as a member of the CIOMS VII WorkingGroup on the Development Safety UpdateReport and the CIOMS Working Group on Stan-dardized MedDRA Queries. He has had the plea-sure of serving on program committees, astrack or session chair and as speaker for avariety of DIA workshops in the US and Japan.

DIA’s ‘Outstanding Service Award’ is givento recognize individuals who consistently,through their volunteer efforts, have madesteady contributions to the DIA mission andvision, exceeding expectations. Dr Geary fulfilsthese requirements not just for DIA, but forPharmaceutical Medicine as a whole – congra-tulations, Dr Geary.

In BriefStewart Geary grew up in Utah on the

western edge of the Rocky Mountains, in the

United States of America. He recalls the influ-ence a high school chemistry teacher had inhis early interest in medicine and pharmacolo-gy. “I enjoyed the advantage of having a terri-fic high school chemistry teacher, Paul Fore,who introduced me to the fascinating world ofchemistry where you could both discover hownature works and apply science to the veryhuman problems of sickness and disease. I wasalso influenced by reading The Microbe Hun-ters, the wonderful book by Paul de Kruif thatdescribes the work of Koch and Pasteur andEhrlich. I remember thinking how neat it wouldbe to discover a new medicine that couldchange the world the way those early discove-ries in microbiology have created a betterworld for us today.”

In 1985 he graduated from Harvard Collegewith a bachelor’s degree in chemistry, thenspent a year doing basic research on insulin-like growth factor receptors at Harvard MedicalSchool before attending Stanford MedicalSchool from which he earned an MD degree in1990. He went on to complete a residency inurology at the Stanford University MedicalCenter in 1996.

His CharacterWhen asked how he first got involved in

pharmacovigilance Dr Geary said, “I had wor-ked briefly in Clinical Development at Eisai Co.,Ltd. for six months between graduation frommedical school and starting a residency in uro-logy, and I had expected to return to ClinicalDevelopment when I was invited back to thecompany after finishing residency, but Eisaihad recently been involved in the withdrawalof an antiviral compound in the Japanese mar-ket and was concentrating on strengthening itsclinical safety and pharmacovigilance operati-ons, so I was assigned to what was then called,somewhat pessimistically, the ‘ADE Depart-ment’ ”.

One unusual aspect of Dr Geary’s career isthat he has spent the last 11 years in Japan,working at Eisai’s headquarters in Tokyo. Heexplains: “For me, Japan has been the idealbase from which to develop my career. Not onlydo I have the advantage of living in one of themost interesting cities in the world, but I amdaily confronted with an environment wheremany assumptions differ from those I grew upwith. Pharmaceutical development is necessa-rily a global enterprise today but we all tend toassume that the approach to pharmaceuticalsin our home country is the most natural or logi-cal one and that can cause friction as we

implement multinational drug developmentprograms. I want to help my colleagues under-stand that there is a variety of validapproaches to the issues we face in drug deve-lopment and marketing, and that we need tomeet the needs of each region as we bring newdrugs to the market.”

Since 1996, he has also worked off-and-onin Regulatory Affairs, but most of his time con-tinues to be spent in the drug safety arena,both during Clinical Development and Post-Marketing. In fact, Dr Geary is Vice Presidentand Global Safety Officer responsible for phar-macovigilance at Eisai Co., Ltd. in Tokyo,Japan. Needless to say, he speaks Japanesefluently.

But then, how does he coordinate all of the-se strands? Dr Geary: “The requirements andexpectations for the safety of pharmaceuticalshave significantly expanded during my careerin the industry, and although there have beenefforts toward global harmonization, in fact wesee that each country has different expectati-ons for how individual safety issues are hand-led. I believe the way to approach this is tohave centralized, uniform scientific assess-ments of safety issues but to allow safety pro-fessionals in each country, working with theirlocal regulatory authority, to interpret howthat assessment is best applied in their localenvironment.”

Dr Geary has published on the Japanesepharmaceutical industry and frequently lec-tures on global pharmaceutical regulations.“My colleagues in Japan expect me to explainthe US and EU regulatory � page 5

Dr Stewart Geary Decorated with DIA’s ‘Outstanding Service Award’Dr Stewart Geary, Tokyo, Japan: “In Pharmaceutical Medicinewe have the opportunity tohelp not just the patients wecould physically see in a dayat the clinic, but to changethe practice of medicine andexpand the treatment optionsfor patients around theworld.”

Dr Stewart Geary: “I sometimes get a chance toindulge my interest in scuba diving.”

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Personal Snapshot

Media Scope

Reports & Concepts

PM – History, GlobalStatus, Evolution

Those interested in the international evolu-tion of Pharmaceutical Medicine should takenote of a review entitled “PharmaceuticalMedicine – History, Global Status, Evolutionand Development” recently published by Pro-fessor Peter D. Stonier, Dr Honorio Silva and DrHerman Lahon (International Journal of Phar-maceutical Medicine 2007, Vol. 21, 4:253-262;available at www.fpm.org.uk members only).The Authors are well-respected experts in Phar-maceutical Medicine and have authoritativelyinfluenced the profession. �

� page 4 environ-ment to them while thosein the US or Europe lookto me to explain the situa-tion in Japan. I learnmore from researching theanswers to their questionsthan they suspect; if theyrealized how little I knewin advance of their questions they would pro-bably look elsewhere for answers!” Thisassumption obviously is far from the truth.

With all those responsibilities at work andin industry associations, what does he do in hisfree time? “My favorite hours are those I spendwith my wife Anna and our three boys, Nathan,Thatcher and Tiernan. I also sometimes get achance to indulge my interest in scuba diving.There are many beautiful locations here in Asiafor coral reef diving and our whole familyenjoys a day at a tropical beach.”

His Vision“In Pharmaceutical Medicine we have the

opportunity to help not just the patients wecould physically see in a day at the clinic, butto change the practice of medicine and expandthe treatment options for patients around theworld. That is a tremendous privilege, but itlikewise requires tremendous effort and team-work from colleagues around the world. Muchof clinical medicine is taught by example, prac-tice and repetition and likewise in Pharmaceu-tical Medicine as we work together, we teacheach other new techniques and approaches insolving the problems of drug safety and deve-lopment. I have benefited greatly from theexperiences and examples of senior colleaguesin industry and I would like to share those les-sons with the next generation of Pharmaceuti-cal Medicine professionals.”

Eckhard Boettcher-Buehler �

IFAPP at the 8th EACPT ConferenceThe Netherlands • The 8th Conference of the

‘European Association for Clinical Pharmacolo-gy and Therapeutics’ – EACPT 2007 – was heldin Amsterdam, the Netherlands, from 29August to 1 September 2007, attended by morethan 850 delegates from 55 countries. IFAPPsponsored two symposia.

The first IFAPP symposium, entitled “Clini-cal research in the EU after the EU Directive”,was attended by some 250 participants whoshowed great interest in the speakers’ com-ments regarding the EU Directive on clinicaltrials.

Marcel Kenter, the Netherlands, reporteddata from a multicenter global study on diabe-tic neuropathy, initiated a few months afterthe EU Directive implementation. His experi-ence was quite negative, with average protocolapproval times in Europe of 85 days (EthicsCommittee, EC, after the EU Directive) and 59days (EC with local procedures); while in theUS approval times were 45 days (local Institu-tional Review Boards – IRBs) and 15 days (cen-tral IRB).

Ernst Singer, Austria, highlighted the decli-ne of academic research after the EU Directive,showing that in his hospital in Vienna theannual number of studies promoted by investi-gators decreased from 200 to only 50 duringthe period 2000-2006.

Heinz Carmann, Austria, provided a detailedoverview of clinical trial opportunities emer-ging in new countries, not only in EasternEurope, but also in China, India, and theMiddle East. Francesco Pignatti, Italy, EMEAmember, reported that regulators are followingvery carefully the evolution of the EU Directive

implementation. He also discussed the oppor-tunities to use new clinical trial designs likeadaptive designs, which is indeed another toolto accelerate studies, as the required numberof patients will be limited. Finally Willem R.Verweij, the Netherlands, member of the Dutchdrug agency, reported on the role of inspectorsnot only to control, but also to educate clini-cal trial actors.

In conclusion, it was a lively symposiumanimated by several insightful questions fromthe audience, which gave IFAPP a good visibi-lity.

IFAPP’s second symposium on “Pharmaceu-tical Medicine: the Vision of IFAPP” was heldduring the early evening of the same day withsome 50 participants. Susan Bews, UnitedKingdom, Adam Cohen, the Netherlands, PeterStonier, United Kingdom, and Juan Lahuerta,Spain, illustrated – respectively – the key roleof the ‘Faculty of Pharmaceutical Medicine ofthe Royal Colleges of Physicians of the UnitedKingdom,’ the interactions between ClinicalPharmacology and Pharmaceutical Medicine,the key role of the pharmaceutical physician,and finally the role of IFAPP’s ‘Council for Edu-cation in Pharmaceutical Medicine’ (CEPM).

Rudolf van Olden, the Netherlands, andDomenico Criscuolo, Italy, who chaired bothIFAPP symposia, commented that both eventswere of good value, were very well presentedby all speakers and contributed to furtherimprove the image of IFAPP among the scien-tific community.

Dr Domenico Criscuolo, Member of IFAPP’sExecutive Committee, Colleretto Giacosa, Italy

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(adapted by Peter Stonier 2007)

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IFAPP Interactive: Please Respond

Short Tutorial in Ethical Conduct Decision-MakingEthics is not a test whether a decision is

right or wrong, but about exploring the impli-cations of making decisions.

The Ethical Decision Concept was introdu-ced at IFAPP’s Executive Committee face-to-face meeting in Vienna in March 2007, stimu-lating interest and discussion. Therefore IFAPPWorld would like to review these concepts toencourage further debate.

What Is Ethics?A common philosophical definition consi-

ders ethics to be the “Science of Conduct,”while others call it “Values Management.” It isall about the fundamental ground rules bywhich we live our lives in the community, gui-ded by common sense behavior.

There are two major challenges to notewhen talking about ethics in general and with-in Pharmaceutical Medicine particularly:� There is a trend that “values,” which previ-

ously were sacrosanct, are now being ques-tioned.

� Assumptions and perspectives are being re-evaluated.Furthermore, the decision process in Phar-

maceutical Medicine has to acknowledge aninternational or global perspective.

Hence the ethical decision calls even morefor a deliberation.

Principles of Biomedical Ethics Four core principles of biomedical ethics

were enunciated by Tom L. Beauchamp andJames F. Childress in 1994 – revised andexpanded upon by almost every important dis-cussion of theory and principle in 2001:“Respect for Autonomy, Nonmaleficence, Bene-ficence, and Justice” [1].

These principles need to be consideredwhen making an informed decision.

The TutorialThe following scenario is a hypothetical

exercise, based on various possible situations.

Scenario1. Health area: Adolescence Pediatrics.2. Investigational product: A new medication

for oral contraception, which already isapproved by the health authorities of someeminent countries and is about to be marke-ted there. The product is as yet not approvedfor women less than 18 years of age.

3. Clinical trial: It is a global clinical trial withparticipating centers in the US and Europe,in Asia and in Africa. Subjects are femalesaged 10 to 18.

4. Trial subject in question: An adolescentfemale aged 13 years with the assumptionthat she is sexually active. She is God-fearing. She is living with her mother, who isa practicing physician with expertise andresearch interest in oral contraception, alsoan investigator.

5. The investigator: Female physician with abroad expertise in oral contraception andclinical experience with adults and adoles-cents.

Dilemma 1:The investigator is the mother of the ado-

lescent female, who is a potential trial subject.

Dilemma 2: The adolescent girl has requested contra-

ception at a clinic without her mother’sknowledge.

Questions1. What are the implications – ethically and

morally? (please comment briefly)2. Are there any religious and global implicati-

ons? (yes or no – why or why not)3. Do you set up any additional assumptions?

(please describe briefly)4. Should the mother decide to put her young

daughter in this clinical trial? (yes or no –why or why not)

5. Should the mother as a physician ask heryoung daughter whether she would be pre-pared and willing to participate in this clini-cal trial? (yes or no – why or why not)

Practical Guides and Business ModelsThere are several business models and prac-

tical guides available to exercise informeddecision-making with ethical principles consi-derations.

As an instruction for the exercise above,and for simplicity, perhaps the Laura Nashmodel [2] with its 12 questions is one, whichfrom an IFAPP World reader’s perspective maybe the most workable. It intends to make deci-sion-making more practical, rather than relyingon abstract philosophical concepts.

The Laura Nash Model

1. Have you defined the problem accurately?Gain precise facts and many of them.

2. How would you define the problem if youstood on the other side of the fence? Con-sider how others perceive it; are therealternatives?

3. How did this situation occur in the firstplace? Consider the history, problem orsymptoms.

4. To whom and what do you give your loyal-ties as a person and as a member of thecorporation? Private duty versus corporatepolicy or norms.

5. What is your intention in making this deci-sion? Can you take pride in your action?

6. How does this intention compare with likeresults? Are results harmful even with goodintentions?

7. Whom could your decision or action injure?A good thing resulting in a bad end? WantA, got B.

8. Can you engage the affected parties in adiscussion of the problem before you makeyour decision? Example: talk to workersbefore closing the plant.

9. Are you confident that your position willbe valid over a long period of time, as itseems now? Look at long-term consequen-ces.

10. Could you disclose your decision or actionwithout qualms to your boss, your CEO, theboard of directors, your family or society asa whole? Would you feel comfortable withthis on TV?

11. What is the symbolic potential of youraction if understood? If misunderstood?Sincerity and the perception of others.

12. Under what conditions would you allowexception to your stand? Speeding to ahospital with a heart attack victim.

Please RespondWe kindly invite you to take a second close

look at the scenario outlined above, and eva-luate the assumptions. Then make an informeddecision on how you would treat the adoles-cent female, or how you would proceed as hermother as a health professional. Utilize theLaura Nash model presented earlier. If necessa-ry for your decision, you are welcome to set upadditional assumptions at your discretion.Then address the questions posed above.

Please respond in an email to IFAPP World(ifapp@planet.nl) – subject “Ethical Conduct”– and provide your answers and brief com-ments, marked with � page 7

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� page 6 Q1, Q2, Q3, Q4 and Q5 – com-plete or incomplete, with or without yourname. We are passionate about the internatio-nal or global ethical perspective in making aninformed decision with regard to this scenario.It is not at all a test whether the decision isright or wrong, but part of a thinking processto improve our decision-making skills. Fromyour responses, we will create further exercisesfor ethical conduct decision-making.

Dr Sander Becker, Co-Chairperson of IFAPP’sInternational Working Party on Ethics, Sydney,Australia, with specific involvement from DrJane Barrett, Member of IFAPP’s Executive Com-mittee (EC), Wokingham, Berkshire, UnitedKingdom, and IFAPP’s EC. �

References: 1. Beauchamp TL, Childress JF: “Principles of Biomedical Ethics”, Fifth Edition,Oxford, New York 2001, Oxford University Press.2. Laura Nash: “Ethics without the sermon”, HarvardBusiness Review 1981, 56/6:79-90.

Reports & Concepts

DIA’s 43rd Annual Meeting • First Part

Bioethics – a Global ChallengeProfessor Gerfried Nell, Vienna, Austria, IFAPP President Elect

USA • Today most clinical drug developmentprograms and clinical trials are global enterpri-ses, only accomplished after bioethical evalua-tion. This calls for certain global standards tobe implemented, which ethical evaluation hasto follow. Therefore it is necessary, to provideessential education for members of Ethics Com-mittees (ECs) and Institutional Review Boards(IRBs, US usage). This was a key session topicat the 43rd Annual Meeting of the ‘Drug Infor-mation Association’ (DIA) in June 2007 inAtlanta, Georgia, USA entitled “Global Challen-ges with Bioethics in IRB’s Training.”

The DIA session intended to draw an inven-tory of existing activities, measures and pro-grams currently in place for education and trai-ning of EC and IRB members in the US, Europeand Latin America. Lastly a comparison of theidentified activities, measures and programswas intended to provide an overview of furtherdevelopment needs.

As agreed by all invited speakers, a specificEC and IRB member educational program ismandatory. However, the activities, measuresand programs for this education as well as legalregulations widely vary from region to region.However, there could hardly be a starker con-trast between the huge monetary investmentsand personnel for education and training of cli-nical research professionals – investigators,Clinical Research Associates (CRAs), clinicaltrial coordinators – on one side and the margi-nal resources spent on EC and IRB member edu-cation on the other side.

USA: Selective Approaches,no Consistent Standards

Chaired by Dr Gustavo Kesselring, Presidentof the ‘Brazilian Society of PharmaceuticalMedicine’ (SBMF), São Paulo, Brazil, the firstspeaker Dr Gary L Chadwick, University ofRochester, NY, USA, explained the US programin his talk entitled “What Is in Place, and Is ItEnough?” For some years the ‘Office of HumanResearch Protection’ (OHRP) of the ‘UnitedStates Department of Health and Human Ser-vices’ (DHHS) has required the chairperson ofan IRB to complete a training course – this waspurely an insurance-related obligation. Cur-rently there are no legal stipulations withregards to any IRB member education or trai-ning, but organizations as, e.g., the ‘Associati-on for the Accreditation of Human ResearchProtection Programs’ (AAHRPP) attended tothis task and called for adequate knowledge

and skills of all, who are in charge for thesafety and rights of patients in clinicalresearch. According to AAHRPP, details have tobe defined by the respective institution.

This lack of consistent regulations has cau-sed huge differences in training requirements,training course formats and qualification of therespective trainers. The training commonly fol-lows the basic requirements of the DHHS andthe ‘Food and Drug Administration’ (FDA) andimparts knowledge of the “Belmont Reports“and ICH E-6 “Good Clinical Practice”.

There are national courses, e.g., sponsoredby the ‘National Institutes of Health’ (NHI) andseveral home-grown courses. Commonly thenational courses are provided by the highestqualified authors with a focus on academicissues, while home-grown courses more likelyaddress the specific needs of a respective insti-tution. The level of training courses differswhether the training is for IRB chairpersons orordinary IRB members; there also are coursesfor beginners and for advanced learners.

Overall, in the US several well-designed andwell-organized approaches are available forcontinued education and training of IRB mem-bers. However, there is no consistent standardand structure currently in place.

The second part of the report with a focus onEurope and Latin America will be published inIFAPP World I/2008. �

IFAPP Interactive

IFAPP’s Regional Update

New AMIFE President in Spain

Spain • In October 2007 the general assem-bly of the Spanish ‘Society of PharmaceuticalIndustry Physicians’ (AMIFE – www.amife.org)elected a new board of directors that will leadthe association for the next two years. NewAMIFE President is Dr José Maria GiménezArnau, Chief Scientific Officer at Novartis Phar-ma Spain, former AMIFE Vice-President anddelegate to IFAPP. Dr Arturo Lopez-Gil, Head ofClinical Development at MSD, is AMIFE Vice-President (VP). Per recently renewed AMIFEstatutes the VP will automatically become Pre-sident in two years.

Sincere thanks were extended to AMIFE PastPresident, Dr Jorge Gonzalez-Esteban, MedicalDirector at MSD, for his excellent work for AMI-FE and the Spanish Pharmaceutical Medicine.The board members showed their gratitude at aceremonial dinner in Madrid right after theelections. �

IFAPP’s Regional Update

New Board of APPAAustralia • In September 2007 Dr Leanne

Wall, Medical Director at Schering-PloughAustralia, was elected as President of the‘Australian Pharmaceutical Physicians Associa-tion’ (APPA). Dr Wall presides the APPA Execu-tive Committee for 2007-2008 with positionsas follows: Vice President Charmaine Gittleson,Secretary Guy Gavagna, Treasurer Malcolm Law-rie, Committee Rob Creek, Eugene Goh, GlenPater, Peter Stewart, Linda Swan. Dr Wall repla-ced Dr Jeffrey Hassall. �

Dr José Maria GiménezArnau, AMIFE President

Dr Arturo Lopez-Gil, AMIFE Vice-President

Atlanta, Georgia, USA

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News from IFAPP’s CEPM

When IFAPP created the ‘Council for Educa-tion in Pharmaceutical Medicine’ (CEPM) in2001, it was given five major objectives:

1. To contribute to the harmonization ofthe existing Postgraduate Courses in Pharma-ceutical Medicine (PGCPMs), to assist IFAPP’snational member associations (nMAs) to esta-blish appropriate educational and training pro-grams in Pharmaceutical Medicine and toaccredit those PGCPMs, which comply with thesyllabus established by IFAPP.

2. To assist Universities to establish addi-tional PGCPMs.

3. To support the development of structuredContinuing Medical Education/Continuing Pro-fessional Development (CME/CPD) programs inPharmaceutical Medicine by the nMAs.

4. To promote the mutual recognition ofequivalent educational qualifications andCME/CPD requirements between countries.

5. To obtain the recognition of Pharmaceu-tical Medicine as a distinct medical specialty.

The CEPM counts 30 members who are tho-se members of the nMAs interested in educati-on and training. Most of them are participatingin one or more of the six Working Groups (WGs)of the CEPM.

Activities

The activities of the CEPM can be summari-zed as follows:

Objective 1: Harmonization and Accreditation of PGCPMs

Between 2002 and 2007 CEPM has organi-zed the visit and accreditation of 11 PGCPMs.Nine are located in European Universities (Bar-celona, Basel, Belgrade, Brussels, Cardiff, Dub-lin, London-Surrey, Madrid and Stockholm),one in the University of Mexico and the mostrecent one is in Hibernia College of Dublin.This program is ongoing and further accredita-tions are expected in 2008.

Working Group I • The IFAPP syllabus forcourses in PM is the benchmark on which theaccreditation of PGCPMs is based. It is anessential tool in the process. WG I has the taskto revise the syllabus when needed and toissue new up-to-date versions. The latestupdated version is available on the IFAPP web-site www.ifapp.org in the section “education”.

Objective 2: Assist in EstablishingAdditional PGCPMs

Since its foundation CEPM has assisted inthe establishment of several Postgraduate

Courses in Pharmaceutical Medicine. Furthercourses are being established or are currentlyin their first year such as at the Universities ofSeoul, Budapest, California, Sydney, BuenosAires, São Paulo, Singapore, Djakarta, and Tei-jin.

Working Group II • This WG was specificallycreated in order to assist in the establishmentof the PGCPM at the University of Budapest.The idea is to create a course for the CentralEuropean Area in cooperation with other cen-tral European universities such as Vienna, Pra-gue and Belgrade.

Working Group III • The objective of WG IIIis to produce an international computerizedinteractive training course for clinical investi-gators. This course was set up in cooperationwith the University of Brussels and is nowavailable under the name “E-Clin”. It will bemade available worldwide to the nMAs throughthe CEPM. The WG III remains responsible forthe updating of the course on a yearly basis.

Objective 3: Assist in EstablishingNational CME/CPD Programs

Establishing CME/CPD programs for pharma-ceutical physicians (PPs) is obviously a localresponsibility and nMAs should give due dili-gence to this problem. The CEPM is prepared toassist wherever help is needed. In order to givesome guidelines to the nMAs the CEPM set upWG IV.

Working Group IV • This WG wrote the “Gui-dance Notes for the Establishment of Continu-ing Medical Education/Continuing ProfessionalDevelopment programs in PharmaceuticalMedicine”. These notes were circulated to allnMAs and are available on IFAPP’s website.

Objective 4: Promote MutualRecognition of Diplomas in PM

The objective is to obtain that the universi-ties whose PGCPM was accredited by IFAPPmutually recognize the equivalence of thediplomas in Pharmaceutical Medicine theyaward to the students who passed successfullythe examinations and/or assessments. This canonly be obtained by bringing together thedirectors of the PGCPMs. As most of the accre-dited PGCPMs are located in Europe, the CEPMdecided to organize a meeting of the directorsof the 13 PGCPMs currently running in Europe.The meeting took place on 7 June 2007 inBrussels and was the foundation meeting ofthe “European Federation of Courses in Phar-maceutical Medicine (EFCPM)”. A Steering Com-mittee was elected, which met for the first

time in Brussels on 16 August 2007. A similarmeeting will be organized for the Asian regionin 2008.

Objective 5: Promote the Recognitionof PM as a New Medical Specialty

Considering that Europe is losing in compe-titiveness versus the US in terms of researchand discovery of innovative medicines, theEuropean Commission in cooperation with the‘European Federation of Pharmaceutical Indu-stries and Associations’ (EFPIA) is setting upan “Innovative Medicines Initiative” (IMI) anda “Strategic Research Agenda” (SRA). Theobjective is to improve the predictivity of effi-cacy and safety of new compounds, to improveknowledge management and to improve thetraining and education of the professionalsinvolved in pharmaceutical R&D, regulatoryaffairs, pharmacovigilance, etc. The latterobjective is of great interest to PPs as it speci-fically mentions the need to recognize Pharma-ceutical Medicine as a new medical specialty.The project involves the creation of a ‘Europe-an Medicines Research Academy’ (EMRA) brin-ging together “centers of excellence” of eachscientific discipline involved in R&D of newmedicines. The objective of the CEPM is toobtain that the “center of excellence for Phar-maceutical Medicine” should be a tripartitebody composed of the European Chapter of theCEPM, the ‘Faculty of Pharmaceutical Medicineof the Royal Colleges of Physicians of the Uni-ted Kingdom’ and the recently founded EFCPMmentioned under Objective 4.

The CEPM counts two more WGs:Working Group V • This WG is in charge of

producing a multilingual glossary English ver-sus several Eastern European languages ofmedical terms used in Pharmaceutical Medici-ne.

Working Group VI • This WG is in charge ofcommunicating on the activities of the CEPMto IFAPP’s Executive Committee, to the nMAs,to IFAPP World. This WG is also responsible forupdating at regular intervals the section “edu-cation” on IFAPP’s website and to provide per-tinent information on the CEPM activities forinclusion in that section.

Dr Herman Lahon, IFAPP’s Treasurer, Brus-sels, Belgium, and Professor Jean-Paul Deslype-re, Member of IFAPP’s Executive Committee,Chairman of CEPM, Singapore �

Education in Pharmaceutical Medicine – an Update

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PM Training Proposal Passes First Filter of theEuropean ‘Innovative Medicines Initiative’

Reports & Concepts

IFAPP News

As reported earlier, IFAPP’s European Chap-ter of the ‘Council for Education in Pharmaceu-tical Medicine’ (CEPM) held a meeting in June2007 in Brussels, Belgium, with the directorsof Postgraduate Courses in PharmaceuticalMedicine from major European universities.The participants agreed to form a group, whichwas tentatively designated as the ‘EuropeanFederation of Courses of Pharmaceutical Medi-cine’ (EFCPM), convened with the aim of agree-ing a common proposal to meet the European‘Innovative Medicines Initiative’ (IMI) callrequirements for a joint project to foster Phar-maceutical Medicine in Europe in the comingyears.

IMI, set up as a not-for-profit organizationand run jointly by the European Commissionand the ‘European Federation of Pharmaceuti-cal Industries and Associations’ (EFPIA), provi-des an excellent opportunity to bring togetherall European parties involved in the educationand training in Pharmaceutical Medicine.Based on IMI’s ‘Strategic Research Agenda’(SRA), the topics for the first IMI call havebeen proposed and agreed upon by the EFPIA

Research Directors Group, representing a pro-portion of major pharmaceutical companies.

“Pharmaceutical Medicine Training Programme”

Among those projects reviewed and initial-ly accepted is a six-page document entitled“Pharmaceutical Medicine Training Program-me”. The document has been prepared in sum-mer 2007 by representatives of IFAPP, of the‘Faculty of Pharmaceutical Medicine of theRoyal Colleges of Physicians of the UnitedKingdom’ and the newly formed EFCPM. Thus,all important stakeholders have had a say intowhat should be addressed for future educationand training of Pharmaceutical Medicine pro-fessionals in Europe.

The “Pharmaceutical Medicine Training Pro-gramme” establishes a number of actions to berolled-out over a four-year period, definingcurrent assets and future needs for the variousstages of education and training. The vision isfor a European network of existing and newacademic centers working in harmony to deli-ver a common Pharmaceutical Medicine sylla-

www.ifapp.org Attracts More and More Visitors IFAPP World is a publication of the

International Federation of Associations ofPharmaceutical Physicians (IFAPP)The Federation, founded in 1975, is a non-profit organization with 30 nationalMember Associations worldwide.

IFAPP acts as an international forum for allpharmaceutical physicians organizationsworldwide by dealing with matters brought to its attention through national MemberAssociations.

Editorial Board Representatives:Dr med. Johanna Schenk, FFPM(johanna.schenk@pharmaprojekthaus.com),Frankfurt/Main, Germany

Professor Dr Jean-Paul Deslypere (Jean-Paul.Deslypere@sgs.com), Singapore

Dr Stewart Geary (s2-geary@hhc.eisai.co.jp) Tokyo, Japan

Editor in Chief:Eckhard Boettcher-Buehler (boebue@t-online.de), D-90562 Heroldsberg, Germany

Associate Editor:Marie Gethins, Glenbrook, Cork, Ireland

Design & Layout:Novum Verlag & Werbung GmbH, D-90542 Eckental, Germany

THE FLAG

bus, under widely accepted training schemes,with advanced e-learning methods. This alsomight include training of investigators in GoodClinical Practice. A quality assessment of thewhole process has to be ingrained right fromthe start.

The IMI process, as established, requiresthe constitution of pairs of consortia (groupsof institutions committed to a particular pro-ject). The first consortium (EFPIA) is made upof pharmaceutical companies as members ofEFPIA. The second consortium (public) shouldbe composed “ad hoc” of academic bodies,small and medium sized enterprises, patientorganizations, regulators, etc., that wouldwork together with the EFPIA consortium tomeet the proposal objectives. The consortiawill be invited – likely at the beginning of2008 – to submit pre-proposals outlining whatthey can offer to solve the issues raised in thecalls. The received pre-proposals will then gothrough a peer-review selection process inorder to combine those most suitable pairs ofconsortia. The opportunity of providing exten-sive and high-quality Pharmaceutical Medicineeducation and training throughout Europeseems closer to become a reality.

Dr Juan Lahuerta, Chairman of the ‘Europe-an Chapter’ of CEPM, Madrid, Spain �

The number of visitors and hits on IFAPP’swebsite has increased enormously in recentyears and may reach a tenfold increase fromJanuary 2000 up to December 2007 (figure).

While there were 8,102 hits from 2,501 visi-tors counted for the year 2000, these figureshave increased to 57,125 hits from 47,024visitors during 2006. Between 1 January and31 October 2007, the counter already showed70,984 hits from 62,929 visitors and this isexpected to increase further by year-end.

These figures clearly indicate a rampinginterest in the information IFAPP provides onits website.

Stimulated by the high number of visitors,IFAPP currently is reviewing its presentation inthe world-wide web with the objective to rede-velop its website for even greater usability. Thelaunch is planned for the first quarter of 2008.

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Hits and visitors on www.ifapp.org year by year:

Numbers

Year

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Brazil • “An exceptional congress” is howparticipants from academia and industry una-nimously described the 4th ‘Latin AmericanCongress of Clinical Research’ which ran from27 to 29 September 2007. Jointly organized bythe ‘Sociedade Brasileira de Medicina Farma-cêutica’ (SBMF) and the ‘Drug InformationAssociation’ (DIA) in São Paulo, Brazil, it had arecord number of lecturers and speakers atten-ding from IFAPP, DIA, the US-American Foodand Drug Administration (FDA), and the Euro-pean Medicines Agency (EMEA). Several dozennational and international exhibitors of allvarieties participated.

Dr Gustavo Kesselring, SBMF President andChairperson of the Congress, summarized: “Theoverall result of the congress is the constituti-on of a greater understanding regarding all cli-nical research facets of the participants whoare professionals from academia, industry,administration and government.”

IFAPP’s Executive Committee Members: Prof GerfriedNell, Austria, Dr Luis Collia, Argentina, Dr JohannaSchenk, Germany, and Dr Gustavo Kesselring, Brazil

Country Selection from Sponsor’s Perspective

When choosing countries for multicenterstudy participation several factors should beconsidered. According to Dr Adri Pols, Vice Pre-sident Global Clinical Monitoring Organon, theNetherlands, these include compliance withGood Clinical Practice standards, skills of pro-fessionals involved in clinical research, andtrustworthy research ethics. Strategic aspectscomprise the cost-benefit ratio, client prefe-rences, local registration requirements, size ofthe domestic market and local marketing per-spectives.

Other issues worth considering are: regula-tory agency flexibility, research subject avail-ability and centers of excellence with optimalperformance, as well as company subsidiarypresence. A reliable information exchangeamong all parties involved in the research is

Reports & Concepts

mandatory, especially when external personnelare involved.

Trials with Orphan DrugsOrphan drug research and development was

subject of a presentation by Dr Carlos Ruchaud,Medical Director, Genzyme, Brazil. In the US itis regulated by the ‘Orphan Drug Act’ (ODA),which became effective in January 1983 as asub-clause of ‘Food and Drug Administration’(FDA) regulations; orphan drug R&D is rewar-ded through tax reductions and marketingexclusivity for the specific drug over an exten-ded time. Since 2000, a similar status exists inthe European Union administered by the ‘Com-mittee for Orphan Medicinal Products’ (COMP)of the ‘European Medicines Agency’ (EMEA).

In Brazil, orphan drug R&D faces many dif-ficulties, since there is no adequate legislati-on. Protocol approvals and marketing authori-zations are time consuming procedures. Alsoimport licensures are complex. For example,even if the orphan drug is offered to thepatient for free, the federal law imposes hightaxes, which can easily exceed budgets. Over-all, physicians, other health professionals aswell as regulatory agents in Brazil need speci-fic information and training in this area.

Currently the Brazilian regulatory agency istrying to solve these problems and ease proto-col approval and importation challenges. Theynow allowed a limited drug reserve in Brazil inorder for better treatment initiation soon afterorphan disease diagnosis.

Pharmacogenomic StudiesPharmacogenomics imposes several issues,

as Dr David A Lepay, Senior Advisor for ClinicalScience at the FDA Office of the Commissioner,USA, outlined in his talk. On ethical grounds,the subject protection concerns in thisresearch area are generally not primarily sub-ject safety, but rather subject rights. These aremore “foreign” and less tangible to scientificand regulatory experts traditionally involved indesigning, conducting, and evaluating clinicaltrials.

An exploratory sub-study should beapproached and must be explained differentlythan a pivotal study involving validated(genomic) biomarkers. But even where thesub-study requires only one “extra vial” ofblood, Good Clinical Practice standards affirmthat subjects need to be informed and askedfor their written consent. The credibility andacceptability of pharmacogenomic studies istied to their ethical credibility and acceptabi-lity. The Independent Ethics Committee (IEC)membership mustbe equipped tounderstand andaddress pharmaco-genomic studies,ensuring that ade-quate provision ismade to protectthe subjects’ rightsand welfare.� page 11

4th Latin American Congress of Clinical Research • São Paulo, Brazil, in September 2007 • First Part

Global Initiatives of Clinical Research in Latin AmericaDr Paulo Aligieri, São Paulo, Brazil

Dr Jorge Fiuza, Argentina, and Dr Carlos Ruchaud, Brazil Dr David A Lepay, USA

Dr Adri Pols, the Netherlands, Dr Gysélle Tannous and Dr Laura Luchini, both Brazil, and Dr Victoria Vazquez, Mexico

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� page 10Experience in Site Inspection

Experience and results of research centerinspections in Argentina were reported by DrAnália C Perez, Argentina, member of theArgentinean ‘Administración Nacional de Medi-camentos, Alimentos y Tecnología Médica’(ANMAT). She described the legal basis andmandatory documents, the process steps, com-mon findings and result synopsis. Voluntaryaction was agreed in 8% of a total of 374inspections and official requirements wereindicated in only 4%. In order to choose aresearch center for inspection, the Argentine-an health authorities consider several factors,

e.g., type of study protocol, rate of enrollment,number of SUSAR reports, etc. Perez underlinedthe importance of training and education tofurther improve research subject safety.

Professional Development and CareerClinical research is an attractive field,

regardless of where it is performed. It results inthe development of new drugs, vaccines, devi-ces, other procedures and other products thatpreserve or improve quality of life. In order todevelop clinical research in Latin America, DrDennis Hurley, Mexico, Vice-President for LatinAmerica with Kendle, said in his lecture “Pro-fessional Development and Career in Clinical

Research”, there are three questions whichhave to be answered: What do I like to do?What do I do well? Will this result in profit?

To ensure excellence in clinical research, anumber of Brazilian and Latin American insti-tutions offer professional support in this field.Furthermore, there are useful journals andwebsites focusing on this subject. Last but notleast congresses, such as the 4th Latin Ameri-can Congress of Clinical Research, are essenti-al to broaden the clinical research understan-ding and expand the clinical research network.The opportunity to interact with more experi-enced colleagues is definitely a key factor insuccess.

The second part of the report will be pub-lished in IFAPP World I/2008 �

Reports & Concepts

Dr Geoff Gerard, USA, Dr Sergio Guerrero, USA, Dr Anália Perez, Argentina, and Dr Elie Fiss, Brazil Dr Dennis Hurley, Mexico

Dates & Deadlines

13-17 January 2008 • Washington, DC, USADIA’s 7th Annual Contemporary Pharmacovigilance & Risk Management Strategies ConferenceDrug Information Association (DIA) • www.diahome.org

31 January – 1 February 2008 • Tokyo, JapanDIA’s 11th Annual Workshop for Clinical Data ManagementDrug Information Association (DIA) • www.diahome.org

5-6 February 2008 • Johannesburg, South AfricaDIA’s African Regulatory Conference: A Forum for Regulatory Authorities and the Pharmaceutical IndustryDrug Information Association (DIA) • www.diahome.org

3-5 March 2008 • Barcelona, SpainDIA’s 20th Annual EuroMeetingDrug Information Association (DIA) • www.diahome.org

9-12 March 2008 • Orlando, Florida, USADIA’s 19th Annual Workshop on Medical CommunicationsDrug Information Association (DIA) • www.diahome.org

17-18 March 2008 • Bangkok, ThailandPharmacogenetics and Drug Safety • Basic Concepts in PharmacovigilanceInternational Society of Pharmacovigilance (ISOP)www.isoponline.org

2-5 April 2008 • Orlando, Florida, USAASCPT’s 9th Annual MeetingAmerican Society for Clinical Pharmacology and Therapeutics (ASCPT)www.ascpt.org

25-29 April 2008 • Boston, Massachusetts, USAACRP 2008 Global Conference & Exhibition in Conjunction with theAPPI Program for Pharmaceutical Physicians and InvestigatorsAssociation of Clinical Research Professionals (ACRP)Academy of Pharmaceutical Physicians and Investigators (APPI)www.acrpnet.org

26-28 April 2008 • Boston, Massachusetts, USAISPE Mid-Year MeetingInternational Society for Pharmacoepidemiology (ISPE)www.pharmacoepi.org

3-7 May 2008 • Toronto, Ontario, CanadaISPOR 13th Annual International MeetingInternational Society for Pharmacoeconomics and Outcome Research(ISPOR) • www.ispor.org

7-10 September 2008 • Amsterdam, the NetherlandsICPM 2008 – 15th International Conference on Pharmaceutical MedicinePlease note the article “ICPM 2008 in Amsterdam” on page 1www.icpm2008.org

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IFAPP’s Regional Update: Spain

Spain • Over the past few years, in the Euro-pean Union important regulations regardingdrug safety have been developed with manda-ted adoption by national regulatory authoritiesand pharmaceutical companies. This new legis-lative framework not only affected day-to-daypharmacovigilance operations, but also raisedseveral specific procedural questions. To findappropriate answers, channel drug safety con-cerns and create fruitful regulatory authorityrelationships, the “Medical Association of theSpanish Pharmaceutical Industry” (AMIFE) setup a Pharmacovigilance Group (SEMIFE), whichis open to all professionals interested in phar-macovigilance.

Initially SEMIFE established several teamsworking on important pharmacovigilancetopics including signal detection, electronictransmission, report quality, pharmacovigilan-ce inspections, and others. With work efficien-cy in mind, these groups were composed of aSEMIFE coordinator and pharmacovigilancespecialists from any company that wished toparticipate. One team had been assigned thecreation of a quarterly team activity bulletin;this bulletin was distributed via email to per-sonnel in charge of pharmacovigilance withinindustry and government authorities in Spain.

Today, SEMIFE’s mission has expanded toinclude training and SEMIFE’s training courses,workshops and symposia are well establishedin creating a consistent approach to streng-then compliance with pharmacovigilancerequirements. In all its activities, SEMIFE ener-getically involves representatives from theSpanish competent regulatory authorities inan attempt to foster awareness of the problemspharmaceutical companies face when turningregulations into practice.

‘Good Pharmacovigilance Practice’Spain has issued legally binding ‘Good

Pharmacovigilance Practice’ regulations, effec-tive for the pharmaceutical industry. Also anew Royal Decree for pharmacovigilance hasjust come into operation, which updates andexpands Spanish pharmacovigilance regulati-ons. Under these new rules, risk managementactivities are essential and pharmacoepidemio-logy, in particular observational post-authori-zation studies (PAS), are being emphasized asan essential tool of up-to-date pharmacovigi-lance in Spain.

In Spain since 2002, PAS have been rigo-rously regulated to prevent utilization as adrug marketing tool. In addition, requirementsare not uniform since Spain has 17 autono-mous regions and two autonomous cities, all ofwhich have developed their own regulations.Therefore each individual PAS needs to beapproved by the competent authorities of eachparticipating autonomous region. However, inpractice the implementation of observationalstudies is highly restricted by local authorities.As a consequence, the number of PAS conduc-ted in Spain has declined dramatically since2002, although their importance in investiga-ting safety questions is beyond doubt.

Fortunately, the new Royal Decree for phar-macovigilance includes a centralized approvalby the Spanish Drug Agency whenever a PAS isrequired by the competent authorities or whenit is part of a Risk Management Plan. The Roy-al Decree also requires the Spanish Drug Agen-cy to register all PAS; furthermore, any PAS ful-filling the definition of a post-authorizationsafety study needs to comply with the legalrequirements of EudraLex Volume 9A.

Electronic ADR ReportingElectronic reporting of Adverse Drug Reac-

tions (ADRs) has also become an importantissue. The Spanish authorities accept registra-tion of foreign ADR reports to EudraVigilance,the central database of the ‘European Medici-nes Agency’ (EMEA). However, ADRs occurringin Spain must be reported to the Spanish Phar-macovigilance Database (FEDRA) with theadditional requirement that narratives must begenerated in both Spanish and English. Thereare two possibilities to comply with the Spa-nish requirements: online data entry intoFEDRA for companies with a low number ofreports, and XML transmission from the compa-ny database to FEDRA and vice versa, recom-mended for companies with products marketedoutside the European Economic Area.

To date pharmaceutical companies havehad to submit each ADR report to the pharma-covigilance center of the autonomous regionwhere the ADR occurred as well as to the Spa-nish Drug Agency. However, in the new scena-rio, ADR reports need to be sent to one siteonly. Marketing Authorisation Holders (MAHs)are required to include the code of the NationalInstitute of Statistics (INE) or the code of theautonomous region to facilitate the systemforwarding the report to the correspondingsite.

Spanish regulations also require theappointment of a permanent and continuouslyavailable Qualified Person responsible for phar-macovigilance (QPPV), who has legal obligati-ons. The roles and responsibilities are similarto those included in EudraLex Volume 9A forthe QPPV at European level, but in the newRoyal Decree an additional responsibility hasbeen added: that within Spain they must ensu-re that there are the necessary mechanisms tocarry out regulatory actions adopted for safetyreasons, as well as all those activities and stu-dies included in the Risk Management Planthat are anticipated will be executed in Spain.

The Royal Decree recently published alsorequires that all materials to be distributed tohealthcare professionals on new medicinesmust carry a pictograph (yellow triangle) for atleast the first five years after marketing autho-rization.

ConclusionPharmacovigilance requires multifunctional

groups that include experts from all areas:regulatory, academy and industry to share ide-as and experiences. Thus, SEMIFE has becomean authoritative voice in Spain. Its ultimategoal is to promote pharmacovigilance as ameans to better protect public health.

SEMIFE Team: Dr C Barajas, Dr D Calderon, Dr T Cuchi, Dr P Diego, Dr I Rebollo, Dr C Rodrí-guez-Lopo, Spain �

Drug Safety: Particularities in Spain

SEMIFE Coordinators of a Pharmacovigilance Symposium (Photo: C Barajas).

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