Download WP5 CEDDC circular letter No4_101207

CEDDC Circular letter 4
WP5 Cooperative European Drug Development Course (CEDDC)
Dear Colleagues,
In a separate files a preliminary agenda for the planned 2nd CEDDC meeting to be held
between February 14-15 in Budapest is enclosed together with other education related
documents. In this explanatory letter I shall summarize the present status of the IMIPharmaTrain project and try to delineate within this frame the work which has to be done
jointly to initiate the CEDDC education in 2012 if possible. To achieve this goal we must
cooperate according to a tightly scheduled program. Everybody is invited to contribute
actively. Success can be expected only if we try to solve the problems jointly.
Please note that all the suggestions presented below should be discussed and
decided upon at our meeting in February!
Provisional Governing Board (GB)
It is recommended that the representatives of the universities who participated at the first
CEDDC meeting and who wish to continue to participate in the CEDDC program should form
a provisional Governing Board which will function until the participating universities sign a
final cooperation agreement. If other universities will join the cooperation their
representatives should also join the Governing Board.
Educational program of PharmaTrain (PhT)
By the end of autumn, the WP3 of PhT finished the curriculum plan for the six modules of the
Base Course. (Please find enclosed the accepted draft curriculum; the final document will be
circulated when the teaching outcomes will be accepted too.) The introductory module
should provide a summarizing overview of Pharmaceutical Medicine /Drug Development
Science (PhM/DDS) for acquainting the students with the concept of the entire course. In the
subsequent 6 modules all the topics of the new PhT syllabus (see enclosed) have to be
covered in a relatively broader, general manner. At the end of the Base Course the students
should understand the entire drug development process, drug discovery, clinical efficacy and
safety evaluation as well as the regulatory and marketing aspects. In addition they should be
able to make appropriate connections between the various processes involved. After the
examination the students will receive a certificate attesting that they finished a Base Course
on PhM/DDS. The approximate length of this part should be around 1 year, maximally 1.5
years according to the training schedule accepted by the course providers. The second part
is devoted for obtaining a MSc degree in PhM/DDS. In this section 6 extension modules
should be delivered, 4 of which will be mandatory for all courses and 2 will be eligible
modules which might be course specific. The extension and eligible courses must provide a
much more detailed discussion of the selected syllabus topics. The various eligible modules
provided by different courses should provide opportunity for the students to adapt their
personal education plan relevant to their specific interest in drug development. Since the 6
basic and the 4 extension modules are harmonized the students might change from one
course to another if desired. The length of the extension part should be similar to the base
course. For obtaining MSc degree the student has to write and defend a thesis, which if
possible should be relevant to the specific work experience of the students. The possible
educational involvement of a leader at the working place of the student is recommended
according to local possibilities.
1
The mandatory extension modules are the following:




Health- and Pharmacoeconomics
Pharmacoepidemiology; Pharmacovigilance; Risk Management
Biological medicinal products; Advanced Therapies, Pharmaceutical technology /
delivery systems / nanomedicine
Special Populations. Clinical trial practice & regulation (pregnant and lactating
women; pediatirc and elderly patients, rare diseases and orphan drugs)
For the CEDDC the two eligible courses listed below are recommended because in our
region the follow-on industry and the use of follow-on medicinal products enjoy an
outstanding priority. Furthermore the thorough understanding of disease biology based
clinical pharmacology of drug application is necessary for all experts working in drug
development


Follow-on generic and biosimilar medicinal products
Disease biology based pharmacology and pharmacotherapy
Each extension module should be followed by a multiple choice examination. The extension
modules might be open for other students not participating in the PhM course. Such students
will get a module certificate on the attendance and successful examination of the given
module.
List of possible lecturers
It is suggested that the majority of the lecturers should come from the academic institutes,
pharmaceutical industry and regulatory authorities of the participating countries. Jointly we
have enough outstanding experts to provide internationally high level education. All GB
Members are requested to provide the GB with a list of suggested lecturers grouped
according to the various topics of the modules. If needed, the educational staff will be
enlarged with international experts. Requirements for the selected lecturers are outstanding
expertise in the recommended topic, fluent English lecturing ability. The primary information
on recommended lecturers should contain the name, the field of expertise, the professional
background (academia, industry, regulatory or health insurance agencies, etc). Based on this
preliminary list we might easily allocate later the lecturers to the actually planned programs.
Delivery of the modules
It is suggested to involve the GB Members in the organization of the education program from
the beginning. Each module should be chaired by two Colleagues from the GB. This will
necessitate that many members will participate in more than one module. On the other hand,
the GB Members will get a well balanced overview of the educational strategy of the CEDDC
and we shall learn to cooperate efficiently. The recommended delivery schedule of the
modules, the list of lecturers suggested by the leaders will be discussed and finally accepted
jointly by the GB. The responsibilities of the leaders of the modules should be the following





make the final time table of the lectures based on the harmonized curriculum
select lecturers from the list of suggested colleagues and discuss with them the goals
and principles of the harmonized course
recommend educational cases and/or assignments for the module
prepare together with the lecturers multiple choice examination questions to be
administered following each extension modules
participate in the evaluation of the assignments and examination
Place of delivery and the administrative coordination of the modules
2
The modules have to be delivered for the entire international student group jointly. All the
modules can be given in Budapest. However, if the CEDDC Members would decide to
deliver the various modules at different places this can be done also. The student related
administrative matters; the administrative coordination of the program even if modules are
presented in another country, will be done by the PhT WP5 group located at the Semmelweis
University in Budapest. In these tasks cooperation with the participating universities will be
maintained as required.
Advertisement of the CEDDC program, accrual of the students
It is recommended that all the participating universities should place the CEDDC program on
their list of available educational activities. In addition the industry should be alerted to this
opportunity. It is recommended that two industrial representatives, Drs. Catrinel G and
Gottwald M should be asked to coordinate this latter project. Together they might mobilize
the support of the regional industry as well as of the EFPIA.
International and national accreditation of the program
The Base Course at the Semmelweis University will be finished by an examination in
January 2011. The material delivered deals with the entire syllabus. Consequently it is
sufficient to apply for an international accreditation by the IFAPP. Since the course at the
Semmelweis University is based on the new harmonized program of the PhT, moreover the
course in Budapest will merge into the CEDDC program; we shall request the IFAPP
accreditation in the name of the CEDDC.
In addition we plan to firmly anchor the entire joint CEDDC Base Course and Master
Extension Programme which will probably start in 2012 into the framework of the EU-EFPIA
supported IMI educational program. This is made possible by the fact that in cooperation with
the IMI PharmaTrain project and its Executive Board, CEDDC is part of a pan-European
network of similar course training activities with shared curriculum standards and best
practices. Since a formal accreditation process, by the new affiliated University training
providers of CEDDC is time consuming to achieve, we plan an interim solution with
immediate implementation. Using the format of the mutual recognition of accreditation among
the University of Basel, King’s College London and the University of Brussels as well as a
similar process at Trinity University in Dublin, the IMI PharmaTrain organisation would coach
a similar process for all network Universities and countries which at present have no
accreditation process in place, including the CEDDC. The interim accreditation process for
CEDDC affiliated Universities in the lap of PharmaTrain would involve a role of CEDDC
University representatives in a new governing and a new examination board. In parallel, a
national accreditation process will be sought as well by the participating universities.
For accelerating and supporting the national accreditation processes it is suggested that
each participation university should request and fill in the documents needed for the national
accreditation with the few data presently available. This process will be a kind of a mock-up
trial for the real accreditation process as suggested by Dagmar Stara from the Comenius
University of Bratislava. In this way we shall get an overview of the information needed to be
collected prospectively to support the later submissions.
Summary of deliverables and suggested deadline: January 15, 2011.
According to our experience the communication from the possible participants is poor.
Questions are answered only by some Colleagues. Please intensify your cooperation starting
now when the details have to be worked out. Without your active involvement the program
will never succeed!
3





Please send back immediately the personal data requested earlier by Judit Whelan .
These data are absolutely necessary for opening the website of the PhT for the
participants and for any further administrative steps
Indicate the module or modules in which you would accept a leading position
List of possible lecturers
Mock-up of national accreditation documentation
Inform regularly the leading officials of your university on the detailed plan presented
above to ensure their continuing support in the development of the joint harmonized
CEDDC PhM/DDS post-graduate MSc educational program and its later submission
for national accreditation.
Dear Colleagues, this is a long circular letter summarizing all the necessary information
needed for your active participation. Please let me know your comments at your earliest
convenience. Regular exchange of comments, information, suggestions would very much
increase the efficiency of our cooperation. Please send the requested information the latest
at the time indicated above.
With the best wishes for a Merry Christmas and a Happy New Year.
Dr. Sandor Kerpel-Fronius, M.D., D.Sc.
Chairman of the PharmaTrain Geographical Extension Project
Professor of Clinical Pharmacology
Semmelweis University, Department of Pharmacology and Pharmacotherapy
Budapest, Hungary
Email: [email protected]
Mobile phone: +36309199574
4