Transcript MK-0966:Timelen

Training of clinical trial specialists and
reviewers:
Current situation of Pharmaceutical Medicine
Kihito Takahashi
President of JAPhMed
The 6th Kitasato University-Harvard School of Public Health Symposium
Tuesday, October 26th, 2005
Today’s Agenda
JAPhMed and IFAPP
Pharmaceutical Medicine: Current Global Situation
Path Forward for Training and Education in Japan
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JAPhMed and IFAPP
Japanese Association of Pharmaceutical Medicine
(JAPhMed)
JAPhMed is a group of physicians, mostly working in the
pharmaceutical industry, with the following goals:



To contribute to the advancement of the pharmaceutical industry
To provide opinions on evaluation of efficacy and safety of pharmaceuticals from medical
point of view
To develop understanding about the role and importance of medical doctors in
pharmaceutical companies

To foster international exchange for the above-mentioned purposes

To promote Pharmaceutical Medicine in Japan
4
IFAPP: The International Federation of Associations of
Pharmaceutical Physicians
The International Federation of Associations of Pharmaceutical
Physicians (IFAPP) was founded in 1975 to promote international
cooperation among medical doctors working in pharmaceutical
companies around the world
Japan, through JAMDI (the predecessor of JAPhMed), was one of
original member countries in the foundation of IFAPP
IFAPP also has a primary objective to establish the role of
Pharmaceutical Medicine and pharmaceutical physicians on a global
basis
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Pharmaceutical Medicine:
Current Global Situation
What is Pharmaceutical Medicine?
Definition of Pharmaceutical Medicine

Pharmaceutical Medicine is a medical scientific specialty concerned with the discovery,
development, evaluation, registration, monitoring and medical aspects of marketing of
medicines for the benefit of patients and the public health
– Faculty of Pharmaceutical Medicine, Royal College of Physicians (RCP)
Careers in pharmaceutical medicine encompass three main groups of
physicians and qualified non-physicians:

Those working in the pharmaceutical industry

Those with appointments within medicines regulatory bodies

Those working in independent research organizations dedicated to the development of
new medicines (e.g. academia, CRO)
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Pharmaceutical Medicine in Europe
In Britain, the British Association of Pharmaceutical Physicians
(BrAPP) introduced a 2-year program of part-time study in 1975
The Royal College of Physicians (RCP) has been supporting this
initiative by providing examinations for a diploma in Pharmaceutical
Medicine based on the BrAPP syllabus
Similar accreditation systems have been adopted in other countries:

Switzerland

Belgium

Germany

France

Italy

Sweden

Spain

Argentina (South America)
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European Center of Pharmaceutical Medicine - Example
European Center of Pharmaceutical Medicine (ECPM) is a university institute
within the Medical Faculty of the University of Basel
Course:

A postgraduate education program especially designed for professionals working within the pharmaceutical industry,
regulatory authorities and university hospitals

Established in 1991, providing specialist knowledge in the field of drug development at an advanced level.

Emphasis is placed on requirements for rational and rapid development of a new drug for the world market
Eligibility Criteria:


Applicants must have a university degree, MD or PhD
The program is aimed at scientists who are involved in the drug development process and have already at least 1 to 2
years of working experience
Diploma:

Participants who successfully complete the course cycle and pass the final (multiple-choice) examination will be awarded
a diploma by the three EUCOR medical schools:
University of Basel, Albert-Ludwigs University, and Louis Pasteur University
Examinations:

A multiple-choice questionnaire for self assessment of acquired knowledge
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ECPM Sessions from 2005 to 2007
Sessions
Topics
Days
1
The Future of Drug Development
4
2
Toxicology and Clinical Pharmacology
4
3
Clinical Trails and Biostatistics I
4
4
Clinical Trials and Biostatistics II
4
5
Regulatory Affairs
4
6
Project and Product Management
3
Final Examination
-
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A majority of Pharmaceutical Medicine Courses accept
both physicians and non-physicians
Except for two universities, most of Pharmaceutical Medicine Courses in Europe
accept both physicians and non-physicians:
100%
Student Ratio Physicians to non-Physicians in each course in Europe
90%
80%
70%
60%
Non-Physicians
50%
40%
30%
Physicians
20%
10%
0%
Belgium: Free
University of
Brussels
France: Claude
Bernard
University, Lyon
Spain:
Autonomous
University of
Barcelona
Spain: Universidad
Complutense de
Madrid
Sweden:
Karolinska
Institutet
Switzerland:
University of
Basel
Source: HP of each school
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United Kingdom:
University of
Surrey
United Kingdom:
University of
Wales, Cardiff
Pharmaceutical Medicine in the United States


The American Academy of Pharmaceutical Physicians (AAPP) has been chartered since
1994 with the mission to contribute toward the progress and advancement of
Pharmaceutical Medicine
The largest single group of physicians in this specialty
– Membership includes medical doctors working for the Food and Drug Administration
– Government-industry collaborative efforts

No accreditation system has been adopted

Educational syllabus compatible with the RCP model has been adopted


A certificate for “Certified Physician Investigator” through a qualifying examination is
offered
Academic training and education:
– Tufts Center for the Study of Drug Development (CSDD)
– Harvard University School of Public Health
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Harmonization of Pharmaceutical Medicine courses:
The Council for Education in Pharmaceutical Medicine (CEPM)
Given the global and various professional aspects of pharmaceutical
medicine, harmonization of the programs is necessary to ensure
consistency of the programs at the global standard
The Council for Education in Pharmaceutical Medicine (CEPM), created
in 2001 under the auspices of the IFAPP, is striving to harmonize the
programs of the existing postgraduate courses in Pharmaceutical
Medicine
The CEPM has already completed accreditation of Pharmaceutical
Medicine courses in the UK (Cardiff and Surrey), Belgium, Barcelona
and Stockholm
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Pharmaceutical Medicine in Japan:
Path forward
Need of Education and Training for clinical trial specialists
and reviewers: What are the issues in Japan?
Several Biostatistics courses and Clinical Pharmacology programs are
available in Japan
Various opportunities and methods exist to develop the expertise
needed for effective drug development Programs and courses are
rather isolated – efforts are therefore segmented
No clear criteria exists regarding the level of knowledge, skills and
experience required for individuals to be accepted as experts in drug
development and reviewers
The lack of clear criteria often results in inconsistencies in the quality
of clinical trials conducted and the evaluation of associated clinical trial
results
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Vision for Pharmaceutical Medicine in Japan
Develop experts in drug development in industry, academia and
regulatory agencies who are capable of leading high quality drug
development with scientific regulatory process
As part of this mission, we wish to:
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Promote excellence in Pharmaceutical Medicine in Japan
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Set standards for Pharmaceutical Medicine
– Certification
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Develop programs and standards in collaboration with academia
– Provide academic study guidance, Develop curriculum
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Tokyo University
Laboratory of Pharmaceutical Regulatory Science
Programs

Intensive Course (IC)
– A seminar which concentrates on a specific timely topic. It will be conducted for two
or three days and held twice a year
• First IC was held on July 8 and 8, 2005
• Second IC is scheduled on January 25, 2006
• Seminar 1 was held on Aug.29, 2005
• First Mini Symposium was held on Sep. 22, 2005

Regular Course (RC)
– A seminar to educate specialists in statistics, data management techniques and
evaluation of drug efficacy that are needed for the development and approval of new
drugs

Lecture for the Graduate Students
– Initiated at Oct 13, 2005
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On-going Initiatives
•Kitasato University School of Pharmaceutical Science
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Post Graduate Pharmaceutical Medicine Course is planned to start in 2006
International collaboration with Harvard University School of Public Health, FDA and other
academic and regulatory bodies
Master and Doctoral degree will be awarded
•Oita University Faculty of Medicine

Undergraduate lectures
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Outline of Pharmaceutical Medicine Program proposed
by JAPhMed
Scope of the Program

Accreditation system compatible with CEPM of IFAPP

Curriculum with practical case studies

Appraisal of the qualification by an external accredited body

Structured continuing education throughout a pharmaceutical physician’s career

Globally harmonized with IFAPP standard
Program Content

Pharmaceutical Medicine curriculum is comprised with following two parts
– Basic Program
• Principally covers the core curriculum of IFAPP syllabus in Pharmaceutical
Medicine
• Suitable for entry class investigators who will conduct clinical trials
– Advanced Program
• Workshop with case studies by the trainers with practical experiences
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Potential programs for JAPhMed
Session
1
2
3
4
5
6
7
8
9
10
11
12
Title
Discovery of New Medicines
Pharmaceutical Development
Toxicity Testing
Legal and Ethical Issues
Development of Medicines
Clinical Trials
Statistics and Data Management
Safety of Medicines
Regulatory Affairs
Information, Promotion and Education
Economics of Healthcare
Medical Department
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Start from
September 2005 ~
December 2005 ~
October 2005 ~
November 2005 ~
Proposed Structure for Pharmaceutical Medicine in Japan
There are three ways to get qualification of Pharmaceutical Medicine
professionals

Qualification of Pharmaceutical Medicine Professional will greatly improve employability
Graduate Students + Company Employees + Physicians
Internet / Independent
Courses
 12 Sessions
Certificate
Academia
OJT, Conference,
Symposium etc.
 Tokyo
 Kitasato
 Others
▪ JAPhMed Course
▪ Tokyo Univ.
▪ Kitasato-Harvard
Diploma
Examination for Qualification
executed by Independent Legal Entity (ILE)
ILE
Univ.
Qualified Pharmaceutical
Medicine Professional (TBD)
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14th International Conference on Pharmaceutical Medicine
ICPM2006
3-6 September, 2006,
Seoul, Korea
Beyond the Horizon

Beyond the Geographical Horizon

Beyond the Technical Horizon

Beyond the Functional Horizon
http://www.icpm2006.org
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Conclusion
It is absolutely necessary to make all the efforts to consolidate training
and education from isolated and segmented forms to a highly
organized, continuous, and comprehensive activity in order to
establish the highly qualified specialists of global standard for clinical
trial and regulatory review
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Acknowledgement

Prof. Masashi Takeuchi (Kitasato University, Dept. Pharmacy, Biostatistics)

Prof. Yuichi Sugiyama (Tokyo University, Dept. Pharmacy, Regulatory Science)

Dr. Kyoko Imamura (Janssen Pharmaceutical KK, Secretariat for Education task team,
JAPhMed)

Dr. Akiyoshi Uchiyama (CEO of Artage, Chair for Education task team, JAPhMed)

Mr. Chris Albani (PRTM)

Mr. Yorozu Tabata (PRTM)

Ms. Mieko Hasegawa (Banyu/Merck)
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