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The IMI project – IMI-PharmaTrain harmonized educational training
Matthias Gottwald
Bayer HealthCare – R&D Policy and Networking
CEMDC, 24 September 2015, Budapest
Joining forces from public and private bodies
The biggest public/private partnership in Life Science aiming to:
Make drug R&D processes in Europe more innovative and efficient
Enhance Europe’s competitiveness
Address key societal challenges
Features:
1:1 funding, joint decision making
All EU funds go to SMEs, academia, patient organisations and regulatory agencies
Large pharmaceutical industry, represented by EFPIA, contributes in-kind
IMI1 and IMI2 - 2008 - 2024
Over 7 000 researchers
59 public-private consortia
International, cross-sector community
842 academic
teams
169 SMEs
480 EFPIA teams
26 patient orgs
20 regulators
Regulators on board of 13
projects
Regulatory authorities in
Scientific Advisory Boards of
50% of projects
61% of projects reported
some form of PATIENT
INVOLVEMENT
IMI Education and Training programs –
The vision
Better trained postgraduate professionals working in medicines
development and regulation worldwide
produce better medicines.
High quality training programs for scientists and lay
audiences developed in the area of medicines R&D
European Medicines Research
Training Network
● Joint development of courses
Syllabus, curriculum, learning outcomes and assessments,
competency profiles
● Joint delivery of courses
Industry, academic and Regulatory Agency lecturers
Real case stories
Course quality criteria
● Blended learning
Face-to-face, distance, e-learning, assignments
● Standardised and collaborative Master programmes
Offered by different universities in different countries
Modular
Life-long learning (CPD)
The IMI course programmes –
a collaborative approach (PPP)
PharmaTrain Achievements
Provision of a Europe-wide comprehensive solution to training needs
of integrated medicines development (sciences) for all professionals
involved
Created, integrated and harmonized existing quality approved
modular programmes of advanced studies in Medicines Development
leading to a postgraduate Diploma or MSc based on the Bologna
credit and title system with 30, respectively 60+ ECTS credits
Created a quality approved list of Short Courses (PharmaTrain
Recognition via www.on-course.eu)
Established a concept for on-the-job based competence development,
leading to a “Specialist in Medicines Development” for physicians and
scientists
IMI PharmaTrain and PharmaTrain Federation
IMI PharmaTrain project: May 1, 2009 – April 30, 2014
• 50 consortium members incl. PharmaTrain Federation, IFAPP, 24 Universities
in Europe, Regulatory Authorities (MHRA, Swissmedic), Learned societies
like EUFEPS, Faculty of Pharmaceutical Medicine, EFGCP, DIA, EORTC and
15 Pharma companies
• 10 Universities from Eastern Europe and 9 outside Europe joined (via
CEMDC and Memorandum of Understanding)
PharmaTrain Federation continues the work of IMI
PharmaTrain
• Legal entity with more than 50 members
• PharmaTrain Federation is part of IMI-TRAIN
• Most partners in IMI PharmaTrain became a member of PharmaTrain
Federation – more industry partners are needed
IMI PharmaTrain Project as a Base
The IMI PharmaTrain project – in parallel with EMTRAIN, SafeSciMET, EU2P and
EUPATI – has developed a framework for pharmaceutical training that creates value
for all stakeholders:
● Quality based Diploma Courses, Master Programmes, Elective Modules,
CPD Modules and e-learning platform: e-library, e-directory, e-services
● PharmaTrain Syllabus (180 topics covering molecule to market)
● 60 Learning Outcomes mapped to the Syllabus
● 70 Competences in seven domains derived from learning outcomes, fitting the industry’s needs
● Quality management system, with a stepwise process improvement cycle
● PharmaTrain brand representing global education and training quality in medicines
development
● European and global network of stakeholders including some 45 universities
● Foundation of the successor organisation to sustain IMI PharmaTrain
IMI E&T Cross Project Quality Criteria
for Courses
A formalised and transparent QA/QC policy
1 – University accreditation OR a suitable system for approving, monitoring and
reviewing the training offered
2 – A system for ensuring quality of teaching staff
3 – Regular review of the QA/QC processes
A set of documented criteria for individual modules, courses or course
programmes
4 – Defined and transparent admission criteria
5 – A predefined set of teaching objectives, leading to defined learning outcomes
6 – Adequate facilities, infrastructure, leadership and competences
7 – Assessment of the trainees' achievement according to the learning outcomes
8 – A system for collecting, assessing and addressing feedback
9 – Adequate reference materials
DMD
Training Centres
PharmaTrain: Standard Setting and Implementation
Certification
Examination
All topics from molecule to marketplace
180 Syllabus topics
60 Learning Outcomes
MMD SMD CLIC
MRA ELM
CPDs
Shared
Standards
Postgraduate
Trainee
Assessment (SPO defined process)
Recognition
Recognised Centres
and Courses
Courses
Standard Setting Implementation
70 Competencies
Curriculum and
modular structure
Molecule to Marketplace teaching the complete PharmaTrain Syllabus
Diploma Base Course CLIC DCTP DMD MMD SMD MRA ELM CPD
Training Centres providing DMD PharmaTrain Centres of Excellence in bold
University of Basel
University of Brussels
Semmelweis University
University Claude Bernard Lyon
Catholic University of Rome
University of Aveiro
Stellenbosch University
Three Universities in Barcelona
(by September 2014)
More Universities from US, China, Japan,
and others will follow shortly
DBM 6 Healthcare
Marketplace and Economics of
Healthcare
DBM 2 Non - clinical Testing to Proof of Concept
in Humans
DBM 5 Regulatory Affairs,
Safety and Pharmacovigilance
DBM 3 Exploratory and
confirmatory Clinical Development
DBM 4 Clinical Trials: Methodology
and Biostatistics
DBM 1 Introductory Module One
PharmaTrain Universities recognized
for Diplomas and/or Master Programmes
(1) Diploma Base Modules, DIMD
(2) Extension Master Programme
(7 total), MMD
(3) UK Diploma
(4) Integrated Master Programme
(7 total), MMD
awarded Centre Recognition** or
Centres of Excellence*** following peer
review site visit
* coaching visit planned
Members of PharmaTrain Federation
awarded Centres of Excellence***
Affiliate to IMI PharmaTran
University Centres Base (Diploma)
Courses
30 ECTS (1)
MMD, ECTS 60+ Member
of Fe-
deration
ExBo member /
guest
WP8
member
IFAPP member
*** 1 University of Aveiro
http://pharmaceutical-medicine.pt/ Hardman Klech Stonier
*** 2 University of Basel, Switzerland, ECPMwww.ecpm.ch Gottwald Boeynaems van Olden
*** 3 Université Libre de Brussels, Belgium,
Pharmedwww.ulb.ac.be/medecine/pharmed
Gottwald Linden Deslypere
*** 4 Semmelweis University, Budapest, Hungary,
CEMDCwww.cemdc.com
Chan Gennery Fuccella
*** 5 University Claude Bernard, Lyon, France,
Eudipharmwww.eudipharm.net
Salek Gennery Franke-Bray
*** 6 Catholic University of Rome, Italywww.rm.unicatt.it/master/ Stonier Kerpel-Fronius Criscuolo
*** 7 Stellenbosch University, Cape Townwww.sun.ac.za Klech Hardman Kiessig
* 8 Three Universities of Barcelona, Spain- Autonomous University of Barcelona
- University of Barcelona
- Universitat Pompeu Fabra
-
-
-Bühler Bass Massud
*** 9 University of Cardiff, UKhttp://www.dpmcardiff.co.uk/index.php Teeling Schaltenbrand Niese
*** 10 Hibernia College, Dublin, Irelandhttp://hiberniacollege.com/courses/master-of-science-
in-pharmaceutical-medicine/Niese Bühler Boeynaems
*** 11 Trinity College, Dublin, Irelandhttp://www.tcd.ie/courses/postgraduate/az/course.php
?id=DPDMD-PMED-1P09Hardman Donaldson Silva
*** 12 University of Duisburg-Essen, Germany, PME
Institutewww.pme-institute.com
Klingmann Klech Clemens
*** 13 King's College, London, UKwww.pharm-med.kcl.ac.uk/drugdev.html Kerpel-Fronius Bass Massud
*** 14 University of Milano-Bicocca, Milano, Italyhttp://www.masterfarmaco.medicina.unimib.it/ Dubois Szucs Criscuolo
* 15 University of Belgrade, Serbiawww.med.bg.ac.rs Klech Nell Stonier
(2)
(4)
(3)
Global University Membership Network 2014
UCSF San Francisco
and at Washington DC Peking University
University of Osaka
Yonsei University Seoul
University of Copenhagen
University Hospital of Freiburg i.Br.
University of Strasbour
University of Basel
Université Libre de Bruxelles
University of Barcelona
Autonomous University
of Barcelona
Universitat Pompeu Fabra,
Barcelona
University of Aveiro
In red: Centres of Excellence
in bold: European University Core Partners and CEMDC Universities,
affiliated membership based on a Memorandum of Understanding
University of Tel Aviv
Kings College London
University of Cardiff
Hibernia College, Dublin
Trinity College, Dublin
University of Vienna
Semmelweis University Budapest
& CEMDC cooperative network
University of Belgrade
University of Milano-Bicocca
Catholic University of Rome
University of Stellenbosch Universidad del Salvador
University of Duisburg-Essen
University Claude Bernard Lyon
Scientific clinical Centre on behalf of
Moscow University
University of Tartu, Estonia
Semmelweis University Budapest,
Hungary
Lithuanian University of Health
Sciences, Kaunas, Lithuania
Medical University of Warsaw, Poland
University of Lisbon, Portugal
University of Medicine and Pharmacy
of Targu-Mures, Romania
University of Belgrade, Serbia
Comenius University of Bratislava,
Slovakia
University of Ljubljana, Slovenia
Gazi University Ankara, Turkey
Partners in the Cooperative European
Medicines Development Course, CEMDC
Thank you