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