Training of clinical trial specialists and reviewers- Current .ppt

1、Training of clinical trial specialists and reviewers: Current situation of Pharmaceutical MedicineKihito Takahashi President of JAPhMed,The 6th Kitasato University-Harvard School of Public Health Symposium Tuesday, October 26th, 2005,Todays Agenda,JAPhMed and IFAPPPharmaceutical Medicine: Current Gl

2、obal SituationPath Forward for Training and Education in Japan,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

3、 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 Pharmace

4、utical Medicine in Japan,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 compani

5、es around the worldJapan, through JAMDI (the predecessor of JAPhMed), was one of original member countries in the foundation of IFAPPIFAPP also has a primary objective to establish the role of Pharmaceutical Medicine and pharmaceutical physicians on a global basis,Pharmaceutical Medicine: Current Gl

6、obal 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 an

7、d 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

8、Those working in independent research organizations dedicated to the development of new medicines (e.g. academia, CRO),Pharmaceutical Medicine in Europe,In Britain, the British Association of Pharmaceutical Physicians (BrAPP) introduced a 2-year program of part-time study in 1975The Royal College of

9、 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),Eur

10、opean 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 industr

11、y, regulatory authorities and university hospitalsEstablished 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

12、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

13、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,ECPM Sessions from 2005 to 2007,A majority of Pharmaceutical Medicine Courses

14、accept both physicians and non-physicians,Except for two universities, most of Pharmaceutical Medicine Courses in Europe accept both physicians and non-physicians:,Student Ratio Physicians to non-Physicians in each course in Europe,Physicians,Non-Physicians,Source: HP of each school,Pharmaceutical M

15、edicine 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 docto

16、rs 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 Acad

17、emic training and education: Tufts Center for the Study of Drug Development (CSDD) Harvard University School of Public Health,Harmonization of Pharmaceutical Medicine courses: The Council for Education in Pharmaceutical Medicine (CEPM),Given the global and various professional aspects of pharmaceuti

18、cal medicine, harmonization of the programs is necessary to ensure consistency of the programs at the global standardThe 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 course

19、s in Pharmaceutical MedicineThe CEPM has already completed accreditation of Pharmaceutical Medicine courses in the UK (Cardiff and Surrey), Belgium, Barcelona and Stockholm,Pharmaceutical Medicine in Japan: Path forward,Need of Education and Training for clinical trial specialists and reviewers: Wha

20、t are the issues in Japan?,Several Biostatistics courses and Clinical Pharmacology programs are available in JapanVarious opportunities and methods exist to develop the expertise needed for effective drug development Programs and courses are rather isolated efforts are therefore segmentedNo clear cr

21、iteria exists regarding the level of knowledge, skills and experience required for individuals to be accepted as experts in drug development and reviewersThe lack of clear criteria often results in inconsistencies in the quality of clinical trials conducted and the evaluation of associated clinical

22、trial results,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: Promote excellence in Pharmaceu

23、tical Medicine in Japan Set standards for Pharmaceutical Medicine Certification Develop programs and standards in collaboration with academia Provide academic study guidance, Develop curriculum,Tokyo University Laboratory of Pharmaceutical Regulatory Science,Programs Intensive Course (IC) A seminar

24、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 s

25、eminar 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,On-going Initiatives,Kitasato University School of Pharmaceutical Science

26、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 awardedOita University Faculty of Medicine Undergraduate lectures,Outl

27、ine 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 physicia

28、ns career Globally harmonized with IFAPP standardProgram 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

29、 trials Advanced Program Workshop with case studies by the trainers with practical experiences,Potential programs for JAPhMed,Proposed Structure for Pharmaceutical Medicine in Japan,There are three ways to get qualification of Pharmaceutical Medicine professionals Qualification of Pharmaceutical Med

30、icine Professional will greatly improve employability,Qualified Pharmaceutical Medicine Professional (TBD),Graduate Students + Company Employees + Physicians,Academia,Tokyo Kitasato Others,Diploma,Examination for Qualification executed by Independent Legal Entity (ILE),OJT, Conference, Symposium etc

31、.,JAPhMed Course Tokyo Univ. Kitasato-Harvard,14th International Conference on Pharmaceutical Medicine,ICPM20063-6 September, 2006, Seoul, KoreaBeyond the Horizon Beyond the Geographical Horizon Beyond the Technical Horizon Beyond the Functional Horizonhttp:/www.icpm2006.org,Conclusion,It is absolut

32、ely 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,Acknowledgeme

33、nt,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),