2015 AUGUST • NUMBER 4

CONFERENCE REPORTINGADVANCING COMPETENT PROFESSIONALS IN MEDICINES DEVELOPMENT– Reports from a PharmaTrain – IFAPP – SSFA* Conference held in Rome, Italy, 10th -11th June 2015 –* SSFA: Societá di Scienze Farmacologiche Applicate – Society for Applied Pharmacological Sciences, the IFAPP member association in Italy
The presentation slides of this conference are available to download on SSFA's website [click here]
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REPORT I:REPORT II:REPORT III:REPORT IV:

CELEBRATING THE FIRST 40 YEARS OF IFAPPMEDICINES DEVELOPMENT – THE GLOBAL ENDEAVOR DEMANDS A GLOBAL E&T APPROACHEDUCATION IN PHARMACEUTICAL MEDICINE: PRESENT AND FUTURE
ADVANCING COMPETENT PROFESSIONALS IN MEDICINES DEVELOPMENT

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2-3
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cation in Europe, Latin America and Asia.
IFAPP has worked closely with the NMAs to
CELEBRATING THE FIRST 40 YEARS OF IFAPP
ensure the scientific and lay public that the deCHAIRPERSONS: Dr Honorio Silva (IFAPP) & Dr Marco Romano (SSFA)
velopment of medicines is in the hands of apgrams to postgraduate education and estab- propriately trained and up to date professionals.
orty years ago the life of physicians in thelished Continuing Professional Development The need for to build a more collaborative inpharmaceutical industry was not particularly (CPD) activities, including international con- frastructure for pharmaceutical R&D inenviable because there were not many phy- ferences. The role of the Faculty of Pharma- Europe and to speed up the development ofsicians employed in each company and jobs ceutical Medicine (FPM) in establishing the more effective and safer medicines wasin the industry came to be regarded as hav- first examination for certification in the United shared by the European Commission and its
ing a low status by others in the profession. Kingdom (UK) as well as maintaining and Innovative Medicines Initiative (IMI). The efToday the biopharmaceuticalforts of Prof Dr Fritz Buhler inindustry has become an interSwitzerland with support fromesting employment opportuother colleagues at the IFAPP
nity for biomedical profesBoard led to the creation of thesionals involved in medicines
European Federation of Course
development. Pharmaceutical
Providers in Pharmaceutical
medicine is an established
Medicine (EFCPM). Both IFAPP
discipline and the profession
and EFCPM were the corehas emerged as a solid cafounding members of Pharmareer path comparable to that
Train, a consortium of academicof serving the community ininstitutions, learned societies andacademic institutions, research
pharmaceutical companies sponcenters, regulatory agencies
Executives from IFAPP, IFAPP Member Associations, and Pharmasored by the IMI, which joined efor clinical practice.
Train at the Conference in Rome, Italy, 10th -11th June 2015
forts to provide a European
comprehensive solution to the
Significant efforts and contriraisingthestandards
andguidelinesfortheeducation and training needs of professionbutions have been made since the initialconception of the founders of IFAPP to the medical practice of pharmaceutical medicine als involved in medicines developments.
PharmaTrain deliverables were an updated
current network of 30 National Member As- has been invaluable.
sociations (NMAs) involving around 7000 IFAPP adapted the initial syllabus prepared and harmonized syllabus, curriculum andprofessionals all over the world. Education by the FPM and established an accreditation quality standards for teaching pharmaceutihas been the cornerstone of IFAPP activi- process for the growing number of academic cal medicine across academic institutions in
ties, evolving from informal educational pro- institutions willing to offer postgraduate edu- Europe.
REPORT I

F2015 AUGUST • NUMBER 4 • Page 2
PharmaTrain became the educational arm of
IFAPP and a close collaboration has beendeveloped over time. A working group fromboth institutions defined the core competencies (knowledge, skills, and behaviors) toperform effectively as a pharmaceutical physician in the development of better medicines.
In addition to be the foundation for outcomesbased education, competencies can be used
to define job descriptions, job portfolios, andcareer paths. The learning outcomes of thePharmaTrain program are effectively alignedwith the core competencies, and thus the
PharmaTrain program can provide the cognitive aspects of the core competencies. The

skills and behaviors can be gained through aspecial on-the-job-based vocational program(Specialist in Medicines Development) recently developed by the PharmaTrain Federation, the successor organization to
PharmaTrain, to be piloted in Italy and Japan
in 2016.
The NMAs are consistently focused in providing services to the growing list of new
members and are eager to participate more
actively and collaborate with IFAPP in theimplementation of educational programs andshare best experiences. A positive responseto the new initiatives and the concepts of certification and specialization has been
granted. The perspectives for further ad-

REPORT II

MEDICINES DEVELOPMENT – THE GLOBALENDEAVOR DEMANDS A GLOBAL E&T APPROACH‘BACK TO THE FUTURE’ ROUND TABLE WITH IFAPP PAST PRESIDENTS

The PharmaTrain – IFAPP – SSFA Con-

ference held in Rome on historic grounds
from 10th -11th June 2015 started with thecelebration of IFAPP’s 40th anniversary.
Five of the sixteen IFAPP past-presidents
to date were invited to participate in a ‘Backto the Future’ session highlighting the evolution of pharmaceutical medicine (PM) as
fostered by IFAPP and allied societies, aswell as the pertinent IFAPP milestones.
Dr Luciano M. Fuccella, IFAPP President
from 1990 to 1994, today Honorary SSFA
Member, underlined IFAPP’s vision of a
global drug development commitment, themain theme of the International Conference
on Pharmaceutical Medicine (ICPM) held in
Rome in 1994. “Think global” was the way
to go after medicines development had
taken place piecemeal at national levels,
frequently leading to diverging outcomes
and labeling. Global development efforts
demand, however, a common understandingof education and training (E&T) needs of theplayers and how to satisfy these.
Thus, the IFAPP program executed from1996 to 1998 under the leadership of its
President, Prof Dr Peter Stonier, United
Kingdom, had – as highlighted by him at
the current Rome conference – education

already high on the agenda. It read: Encourage E&T of pharmaceutical physicians to a recognized high standard ofcompetence for work in the global
pharmaceutical industry.

The PharmaTrain – IFAPP – SSFA Rome Conference, a memorable meeting on historic grounds

Strive towards a common standard oftraining, through introduction of a coresyllabus of pharmaceutical medicine
and development of structured training
courses with their respective examinations and qualifications.
 Seek specialty recognition of pharmaceutical medicine.
In Dr Johanna Schenk’s presidency (2000
to 2002) two IFAPP bodies were “built tovancement of pharmaceutical medicine as adiscipline and profession look very optimistic,
including strategic alliances and collaboration with key stakeholders. A long-term plan
involving IFAPP’s leadership and that of the
NMAs has been put in place and hopefully would
be achieved within the expected timelines.
This vision was fully shared by Dr Keith
Bragman, FPM President, UK, who commented that only a large cooperation from all
involved parties willachieve the ambitious
target of a globally
harmonized education.
Dr Honorio Silva,
IFAPP President Elect, USA

last”, one being the Working Party on
Ethics, later renamed to PM Ethics Council(PMEC), and the Council on Education in
PM (CEPM). The latter had its roots in theearlier Working Party on Education in PM,composed of IFAPP representatives andPM course providers. From its foundationin 2001, the CEPM has been a body constituted of national IFAPP member associations (NMAs) only closely cooperating withboth established and emerging course providers and allied societies.
From the 1998 Boston ICPM, IFAPP’s efforts to become a truly global federation
were reflected by IFAPP meetings at the II
Pan-American Conference in Buenos Aires, Argentina, in November 2001 and the2002 ICPM held in Cancún, Mexico. Fourof seven IFAPP presidents since that timecame from the Americas or Asia, three only
from Europe.
One of the latter, Dr Domenico Criscuolo,
IFAPP President from 2002 to 2004, today
Head of the IFAPP WORLD Editorial Boardand the Italian member of the IFAPP
House of Delegates, strengthened the educational cooperation with the European
regulatory authorities in annual EMEA(earlier acronym for European Medicines
Agency) IFAPP Conferences during his
term. He engaged himself in the recruitment of new member associations, thus,
enlarging the platform for common standards in PM matters and, particularly, E&T.
Prof Dr Gerfried Nell, Austria, the fifth past-

2015 AUGUST • NUMBER 4 • Page 3
president in attendance who was at the
IFAPP helm from 2008 to 2011, has been astrong supporter of IFAPP’s constitutional
aims of fostering the development of training
and continuing educational programs in PM.
This is mirrored by his active engagement in
the collaboration effort between IFAPP andPharmaTrain.
As highlighted in this Back-to-the-Futuresession E&T is the foundation for the entire
value chain in medicines development.

IFAPP has been pursuing this path with patience and persistence from its foundation.
E&T is now more than ever before a core
IFAPP activity driven by currently 30 national
member associations from all continents. For
good reasons it includes E&T of medicines
development scientists nowadays.
Moving forward and going beyond E&T, deployment of professional social media for efficient, real-time and cost-effective global

REPORT III

EDUCATION IN PHARMACEUTICAL MEDICINE:
PRESENT AND FUTURE
CHAIRPERSONS: Dr Ingrid Klingmann (PTF) & Dr Gustavo Kesselring (IFAPP)

This session was fully devoted to what has

been done in the last decade regarding education and training in pharmaceutical medicine (PM) by multiple stakeholders in academia and in the pharmaceutical industry.
Dr Mike Hardman from AstraZeneca gave an
overview on how the Innovative Medicines
Initiative (IMI) has been conceived by theEuropean Commission that looked forward
to accelerate drug development mainly inEurope through all research and educational
platforms and institutions already establishedin this region. In this context he has explained the IMI-Train as a European partnership of the public and private sector to provide education and training solutions in the
medical, biomedical and pharmaceutical sciences, which meet the needs of the pharmaceutical industry, of regulatory agencies,
academic institutions, and healthcare systems through its global training course offers
and training services. An interesting example
on how the same concept works in other industries is the recently opened (September2014) University Technology College Modelfor engineers in the auto industry.
Dr Ingrid Klingmann, PharmaTrain Federation,(PTF) presented PharmaTrain’s main objectives:«To provide a Europe-wide comprehensive solution to training needs of integrated medicines development (sciences)
for all professionals involved, incl. physicians, pharmacists, pharmaceutical scientists, biologists, biometricians, healtheconomists, safety and regulatory scientists from universities, regulatory agencies, all industry as well as research
ethics committees and investigators.

To create (new) and integrate existing
multi-modular programs of advanced
studies in pharmaceutical medicine/
medicines development sciences leading
to a postgraduate Diploma or Master of
Science, based on the Bologna credit andtitle system with 30, respectively 60+ ECTS
[European Credit Transfer System] credits.
To establish the concept for on-the-jobbased competence development, leading
to a “Specialist in Medicines Development” for physicians and non-physicians.»

This ambitious long-term program is being
fully supported by IFAPP.
Dr Antonio Torsello, University of MilanoBicocca, and Dr Francesco de Tomasi, Uni-

communication on PM and IFAPP matters,
as well as a PMEC revitalization, werestrongly recommended. “Who if not pharmaceutical physicians should have a primary responsibility for
ethics in PM operations?”
asked Dr Schenk in her
concluding remarks.
Dr Johanna Schenk,
IFAPP Editorial Board
Representative, Germany

versitá Cattolica del Sacro Cuore in Rome,
explained how the two master courses indrug development, accredited by PharmaTrain as Centers of Excellence in Italy,
are organized. Those courses have beenrunning in Italy since 2007 and have already graduated 490 students with a highsatisfaction and a high degree of employment for all graduated students.
Prof Dr Peter Stonier from the PTF has described the concept of a Specialist in Medicines Development (SMD). Currently, academically in medicine or life sciences qualified persons working in medicines development are trained on the job and undertake continuing professional development(CPD) or participate in university training
courses to achieve a secondary diploma
and/or master degree. All this leads to acertain individual array of competencies
across multiple domains. So far, there is no
qualification, degree or award available inmost countries, which certifies the successful training described, and the PharmaTrain
SMD certification concept and programaims to fill this gap.
An SMD program has started in 2015 in Italy and Japan with a joint collaboration between the IFAPP National Member Associations in both countries and the PTF. According to Dr Heinrich Klech, PTF, this program is overseen by a Global Certification
Board with members from Europe, Japan, USA, Latin America and South Africa.
Dr Kyoko Imamura from the Japanese Association of PM (JAPhMed) has illustrated
how the SMD certification program is being
implemented in Japan in close collaboration with the Osaka University as a PharmaTrain Center of Excellence. Their plan is2015 AUGUST • NUMBER 4 • Page 4
to raise awareness of the value of education,
training and certification by a third party inJapan, to develop a consortium of relevant
parties for wider recognition in the society
and realize joint recognition of SMDs in industry, academia and regulatory authorities.
Prof Dr Sandor Kerpel Fronius, Semmelweis
University, Hungary, has focused on aspectsof education and training needs in medicines
development, regulation and clinical research in low- and middle-income countries.
He concluded that local experts and organizations should coordinate education in suchcountries. However, international cooperation is recommended and the internationally accredited educational material should

be tailored in content and complexity tolocal needs.
Dr Honorio Silva, IFAPP President Elect, haspresented the global perspective of competencies for the clinical research enterprise.
Describing the inefficiencies in clinical research he has addressed the value of professional competencies and the results of
the Joint Task Force (JTF) on clinical trials
core competencies and the international
validation of JTF competencies and educational needs assessment. This competency
approach is being developed in all educational programs of PharmaTrain and IFAPP.
Finally Dr Jean-Marie Boeynaems from theEuropean Clinical Research Infrastructures

REPORT IV

ADVANCING COMPETENT PROFESSIONALSIN MEDICINES DEVELOPMENTCHAIRPERSONS: Dr Peter Stonier (PTF) & Dr Domenico Criscuolo (SSFA)

scientific associations and the
The last session of the Conference was en- regulators,
pharmaceutical industry. His suggestions weretirely devoted to the analysis of the Italianstatus of training in pharmaceutical medicine, as this can be appreciated from different points of views. The first two speakers illustrated their opinions in their role of regulators. Prof Dr Sergio Bonini, European Medicines Agency (EMA), remarked that many
training initiatives are currently ongoing, bothat the EU level and the national level. He
mentioned the efforts put in place by the
Faculty of Pharmaceutical Medicine (FPM),
by IFAPP, by the PharmaTrain Federation(PTF), and finally he underlined the key role
played by several EU universities, whichhave established master courses in pharmaceutical medicine/medicines development
sciences many years ago. He stated that for
the EMA as well training is a priority, and infact a lot of support is offered to several educational activities. As an example to reinforce the key role of a higher education ofpharmaceutical medicine professionals, hementioned that the EMA is fully committed to
grant adaptive licensing to innovative drugs,
but this approach requires well-trained professionals, able to capture any signal arrivingfrom patients’ experience. He concluded
stating that the ideal training should be delivered by a joint network of universities,

immediately reinforced by Dr Sandra Petraglia from AIFA, the Italian Medicines Agency,
who noted that in Italy there is still a significant lack of training in particular for clinicalinvestigators participating in highly complex
clinical trials with most innovative drugs.
Dr Mariapia Cirenei from AICRO, the Italian
network of contract research organizations(CROs), underlined that training of professionals employed in CROs became mandatory in Italy by law in November 2011, whichclearly defined training obligations of mostprofessionals working in drug development
within CROs (strangely enough, not a similar
requirement is in place for people working in
the pharmaceutical industry). She commented that the quality of CRO services anddeliverables in Italy definitely increased after
implementation of this law. Today, CROs in
Italy are well prepared for future challenges,
which certainly will arise from the new EU
Clinical Trial Regulation, she concluded.
The last two speakers were representativesof two learned societies, which are highlycommitted to education. Prof Dr Luca
Steardo, Italian Society of Pharmacology,
underlined once again the significant dedication to education in pharmaceutical medicine

Network (ECRIN) presented the Clinical Investigator Course (CLIC) program as a clinical investigators training. Despite its hurdles
it is making progress and has inspired European initiatives in France, Portugal, Hungary
and had an impact in Japan.
All presentations clearly showed that only ajoined effort with all stakeholders – industry,
academia and regulators – will win the challenge of education andtraining needs in theclinical research enterprise.
Dr Gustavo Kesselring,
IFAPP President, Brazil

demonstrated over several years by specialized bodies like IFAPP, the FPM and the
PTF. Prof Dr Massimo di Maio, Italian Association of Medical Oncology, reported that
oncology should lead the way of education,
as nearly 40 percent of clinical trials involvecancer patients. He commented that significant progress was made in the last two decades with the formation of networks of collaborative groups, able to recruit large patient populations in a short period of time,and at the same time disseminating the culture of education in clinical trials. He also reported that the association of oncologists isworking hard on several programs, from thecertification of clinical sites to guarantee
quality and competence to the institutionalrecognition of key professional roles, like theones played by clinical research coordinators, research nurses and data managers.
In closing the session, both chairpersons expressed high appreciation for the messages
delivered by all speakers, who made a continuous reference not only to the pioneer rolein education played by IFAPP, the FPM and
the PTF, but even more to the need for abetter educational approach for all professionals involved in medicines development,from clinical investigators to regulators, andto professionals working
in the pharmaceuticalindustry and CROs.
Dr Domenico Criscuolo,
IFAPP Delegate, Head of
IFAPP WORLD Editorial
Board, Italy

2015 AUGUST • NUMBER 4 • Page 5
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The Flag20th ANNIVERSARYIFAPP WORLD is a publication of the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine.

SWISS SYMPOSIUM IN
PHARMACEUTICAL MEDICINE

Editorial Board Representatives:
Dr Johanna Schenk,
FFPM, Frankfurt/Main, Germany
johanna.schenk@pph-plus.com
Dr Domenico Criscuolo,
FFPM, Milano, Italy
dcriscuolo@genovax.it
Dr Gustavo Kesselring, São Paulo, Brazil
gustavo.kesselring@visresearch.com

Editor in Chief:
Eckhard Böttcher-Bühler, Eckental, Germany
boebue@boebue.de | www.boebue.de

IFAPP’s Sponsors
IFAPP gratefully acknowledges generous
sponsorships and financial support from:

GlaxoSmithKline plc.
(Platinum Sponsor)
Pfizer Inc.
(Gold Sponsor)
As a not-for-profit organization IFAPP appreciates the support it receives from institutions
and companies with a passion for enhancing
the knowledge, expertise and skills of pharmaceutical medicine professionals worldwide.
IFAPP is in search of further Sponsors. Detailed
information on sponsorship opportunities is available at www.IFAPP.org in the section “sponsors”.

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