SafeSciMET

European Modular Education and Training Programme in Safety Sciences for Medicines
Ongoing | IMI1 |
EUROPEAN MODULAR EDUCATION AND TRAINING PROGRAMME IN SAFETY SCIENCES FOR MEDICIN

FACTS & FIGURES

Start Date
End Date
Call
IMI1 - Call 1
Grant agreement number
115012

Contributions
IMI Funding
2 374 904
EFPIA in kind
3 607 540
Other
513
Total Cost5 982 957

Summary

SafeSciMET is a new and unique pan-European network, which will develop and establish a comprehensive modular education and training programme in safety sciences for medicines. The network brings together eighteen top institutes for drug safety education and research and fifteen pharmaceutical industry leaders. The SafeSciMET courses are open to all scientists from industry, academia and regulatory agencies and will encompass the safety, ethical, regulatory and societal aspects of drug discovery and development.

Professionals will be able to follow single courses in safety sciences or selected subsets of courses, to be accredited for Continuing Professional Development (CPD). Scientists successfully completing the full programme, including a Master thesis, will be awarded with an accredited Master of Advanced Safety Sciences of Medicines. All training courses will be aligned with the Bologna process.

The training will lead to a new generation of safety specialists with strong competences in the application of novel technologies in risk assessment. They will be able to perform reliable evaluations of the safety of drug candidates and new medicines by linking data from laboratory tests with patient data in a more effective way. More targeted training of scientists will speed up biopharmaceutical innovation and may lead to a cost reduction in drug development.

Early insight in the safety aspects of a candidate drug will reduce adverse effects in the later, clinical research phases and will improved the quality of life for patients, as a result of improved drug safety evaluation and regulatory procedures.

Achievements & News

SafeSciMET regulatory course – sign up now!
Registration is now open for the Regulatory Requirements and Guidelines course run by IMI education project SafeSciMET. ###Drug development and production underlies laws and regulations to secure protection of human, test animals and the environment. This course will provide participants with a comprehensive overview of the required in vitro and in vivo nonclinical studies, strategies for the development and risk assessment of new pharmaceuticals. While the focus of this course is mainly on the EU perspective, procedures and guidelines reflecting the international harmonisation of requirements (in the EU, US and Japanese) will also be covered. SafeSciMET offers an intense and broad training with leading experts in their field and ample opportunities for lecturer-student interactions.  This course and the other single courses of the SafeSciMET programme provide new opportunities for Continuous Professional Development (CPD) and are part of European Master for Advanced Safety Sciences for Medicines degree at the University of Konstanz. The course will take place 23 to 27 January in Lisbon and the registration is open until 20 December.
- Course brochure 
(November 2016)

Sign up for SafeSciMET’s courses on clinical safety and in vitro models
Registrations are open for two SafeSciMET courses which will be held in September this year.###
 - Clinical safety: post-approval – 12-16 September 2016, Paris (France) - More information
 - Innovative in vitro models in drug safety assessments – 13-16 September 2016, Liverpool (UK) - More information
IMI’s SafeSciMET consortium offers a variety of custom-tailored solutions to education and training needs for drug safety specialists. For current developments within the project and planning for the future, read the project’s InBrief newsletter. (July 2016)

SafeSciMET predictive cell culture systems course – sign up now!
Registration is now open for a course on predictive cell culture systems run by IMI education project SafeSciMET. The course, led by scientists at Germany’s Martin-Luther-University Halle-Wittenberg, is a ‘blended learning’ course, meaning participants will follow a number of modules online before a three-day face-to-face session in Halle. ### ‘This blended course setup enables participants to prepare for the full-time F2F 3 day course next to job obligations,’ explains Sanja Dragovic from the project. ‘This means less time away from office and family.’ This course introduces the principles of cell culture systems as a tool to monitor homeostasis and early onset of functional imbalance leading to toxicity as well as their use and impact in drug discovery and development. Upon completing this course, students will be able to evaluate the strengths and the limits of specific cell culture systems and to discriminate between biochemical and cellular assays, in vitro and in vivo tests for safety purposes. SafeSciMET courses offer an intense and broad training with leading experts in their field and ample opportunities for lecturer-student interactions. The balance of academic, industry and regulatory teachers provides knowledge directly available to drug safety assessment, including dataset discussions from real case studies.
 - Watch SafeSciMET's video
 - Course brochure (January 2016)

SafeSciMET Mutagenesis and Carcinogenesis Course: register now!
Registration is open for the third course on Mutagenesis and Carcinogenesis organised by IMI Education and Training project SafeSciMET. The course will be held in Vienna, Austria from 28 September to 2 October 2015 and the deadline for applications is 29 August. Besides heredity and environmental factors, chemical exposure is responsible for approximately two thirds of all cancers. ###The development of new chemicals holds the potential risk of mutagenic and /or carcinogenic effects on humans. Minimising these risks during drug development requires experimental approaches and expert knowledge whose basic principles will be delivered in this course. Special emphasis will be given to the biology of cancer, the identification of mutagens and carcinogens and their modes of action on the cellular, biochemical and molecular level. In silico prediction as well as animal systems and tissue culture assays for carcinogenicity testing will be presented. Furthermore, the importance of estimating dose-dependent probabilities of mutagenic/carcinogenic effects and risk-benefit evaluation will be discussed. In case studies from industry, participants will review and assess safety data for mutagenic and carcinogenic compounds. The teachers include academia and industry experts and the interactive programme guarantees a solid understanding of the latest developments in mutagenesis and carcinogenesis. Download the course brochure. Apply here. (June 2015)

SafeSciMET project offers new Master’s degree in Advanced Safety Sciences for Medicines 
IMI Education and Training project SafeSciMET provides graduate students with a completely personalised approach to their post-graduate continuing professional development. A ‘pick and mix’ modular system of custom-tailored education and training courses in safety sciences for medicines, covering the value chain from discovery to usage, including regulatory requirements, the use of animals, and ethics provides a pan-European education and training network.###
As of September this year, one of the 19 project partners, the University of Constance in Germany, can now award the Master of Science (MSc) degree in Advanced Safety Sciences for Medicines. The SafeSciMET courses and the Master’s study programme are fully compliant with the requirements of the European Bologna process for credit transfer. The University of Constance has also signed the Code of Conduct for foreign students studying at German universities, committing itself to quality standards in service and support of international students before and during their studies. In 2012, the University of Constance received the ERASMUS E-Quality Label for excellent performance in handling the ERASMUS programme and offering multiple services to incoming students.
More information about the project and courses offered by SafeSciMET.

Sign up for SafeSciMET’s next round of courses
Registration is now open for the next round of courses, starting in September 2014, offered by IMI project SafeSciMET. A good understanding of safety sciences is key for new and better medicines – from ###initial discovery to end use. With this in mind, SafeSciMET has developed 20 new Master-level courses in ‘safety sciences for medicines’ that are designed to meet the needs of scientists working in industry, regulatory organisations, and academia. Feedback from these courses has been extremely positive. Courses can be taken individually, or built into a well-defined study package, leading to a European Advanced Master’s Degree in Safety Sciences for Medicines, provided by the University of Constance, Germany, in close collaboration with other academic institutions providing the individual courses. For the first time, in response to student feedback, the project’s popular introductory course on safety sciences in drug discovery and development will be offered by a mix of distance or e-learning and face-to-face training.
For more information about the next SafeSciMET course cycle and the complete programme, or to send questions to the SafeSciMET team, consult the SafeSciMET website
(May 2014)

Meet the IMI Education and Training Programmes
There are five projects within IMI’s research training platform aiming to revolutionise education and training to deliver more effective and safe new medicines for patients – EMTRAIN, Eu2P, EUPATI, PharmaTrain, and SafeSciMET. Collaboration is the key to ###success and equally important is the projects' ability to reach intended audiences with information to raise awareness and encourage people to get involved in project activities. 
Over the next six months these projects will be represented at a variety of European and international conferences through display booths, dedicated sessions or individual presentations. If you are planning to attend any of the following events, please take the opportunity to stop by and find out what is happening in the IMI training and education programmes and how you can benefit, either from a professional or personal perspective. 
   - DIA EuroMeeting 2014  (Vienna, 25-27 March)
   - EUPATI Regional Meeting 2014  (Warsaw, 2-3 April)
   - World Research and Innovation Congress (Amsterdam, 5-6 June)
   - Euroscience Open Forum (Copenhagen, 21-26 June)  
(December 2013)


BIOVISION and the IMI Education & Training projects
IMI and the IMI Education & Training projects participated in BIOVISION - the World Life Sciences Forum, which was held in Lyon, France, on March 24-26 2013. It is the place where key stakeholders ###debate the impact of the latest scientific advances on society and share their vision on how to overcome health, environment and nutrition challenges. IMI Executive Director Michel Goldman participated in the plenary session ‘How to make better use of collective intelligence’. Mike Hardman, project coordinator of EMTRAIN, represented IMI and the IMI E&T projects in the BIOVISION Investor Conference workshop. Moreover, the IMI E&T projects organised a satellite event on ‘Training and Education in Europe’ where they  presented their activities to the forum’s participants at a booth in the exhibition area.
(February 2013)

IMI Education & Training projects in the spotlight at DIA EuroMeeting 2013
This year’s DIA EuroMeeting, which was held in Amsterdam, the Netherlands from 4 to 6 March, featured an entire theme dedicated to IMI’s five Education & Training (E&T) projects. The sessions featured ###the latest news from the projects and demonstrated how they are helping to advance education in the biomedical sector in Europe. DIA EuroMeeting visitors could also catch up with the projects and find out how IMI’s E&T projects can boost their careers.
 - View the agenda for the IMI theme in the DIA EuroMeeting programme  (page 46)
(February 2013)

Check out the IMI Education & Training projects’ video
Four of IMI’s Education & Training projects have put together a short video on their activities.###In the six-minute clip, the coordinators of the EMTRAIN, SafeSciMET, Eu2P, and PharmaTrain projects present their courses and the benefits they offer for students and course providers alike. The film also features a presentation by IMI Executive Director Michel Goldman.
(November 2012)

SafeSciMET courses – sign up now!
SafeSciMET, the IMI Education & Training program for Safety Scientists, has successfully completed its first cycle of courses in 2012, with participants giving very positive feedback. ###The project has now announced the start of the second course cycle, which runs from 2012 to 2014. Registration is already open for a number of courses, including Drug safety of stem cells and other novel therapeutics (26-30 November, Liverpool, UK). Topics covered in this course include the basic biology of stem cells and molecular therapies, drug safety aspects of novel therapies, the regulatory requirements for stem cells and novel therapies, and the application of stem cells in the safety assessment of conventional compounds. A full list of forthcoming courses can be found online.
- Download an overview of the courses planned up until August 2014.
(October 2012)

SafeSciMET launches courses on clinical safety
IMI Education and Training project SafeSciMET launches three new courses in the area of clinical safety. The course ‘Clinical safety:pre-approval’ runs on 21-25 May in Basel, Switzerland;### ‘Clinical safety: post-approval’ will run on 11-15 June in Lyon, France; and ‘Stratification, pharmacogenetics and drug safety’ runs on 27-31 August in Stockholm, Sweden. Applications for the new courses are now open via the project website.
(February 2012)

SafeSciMET opens it's new 'safety programme
New safety programme on safety sciences' which includes courses on ‘safety pharmacology’; ‘non-clinical safety assessment: strategies, ethics and protocols’; ‘biomolecular analysis: from method development to clinic’; and ‘predictive cell culture'.
(December 2011)

The IMI Education & Training project SafeSciMET has opened registrations to its first course, 'Drug Discovery and Development'
This is the introductory course to the new European Masters degree for Advanced Safety Sciences for Medicines designed by SafeSciMET. The course takes place in November 2010 and consists of 5 days at the University of Copenhagen with lectures, presentations and discussions, followed by one week home assignment of case studies and course questions.### Registration is open on the SafeSciMET website . A brochure on the course is available here . All the forthcoming SafeSciMET courses are listed on the website , any of them also available one by one, for instance for continuing professional development.
(September 2010)

Participants Show participants on map

EFPIA companies
  • AstraZeneca AB, Södertälje, Sweden
  • Bayer AG, Berlin, Germany
  • Boehringer Ingelheim International GmbH, Ingelheim, Germany
  • Eli Lilly and Company Ltd, Basingstoke, United Kingdom
  • F. Hoffmann-La Roche Ltd, Basel, Switzerland
  • Glaxosmithkline Research And Development LTD, Brentford, Middlesex, United Kingdom
  • H. Lundbeck A/S, Valby, Denmark
  • Laboratorios Almirall S.A., Barcelona, Spain
  • Merck KGaA, Darmstadt, Germany
  • Novartis Pharma AG, Basel, Switzerland
  • Novo Nordisk A/S, Bagsvaerd, Denmark
  • Orion Corporation, Espoo, Finland
  • Sanofi-Aventis Research and Development, Chilly Mazarin, France
  • UCB Biopharma SPRL, Brussels, Belgium
Universities, research organisations, public bodies, non-profit groups
  • Charité – Universitätsmedizin Berlin, Berlin, Germany
  • European Federation for Pharmaceutical Sciences, Järfälla, Stockholm, Sweden
  • Hospices Civils de Lyon (Lyon General Hospitals), lyon, France
  • Karolinska Institutet, Stockholm, Sweden
  • Københavns Universitet (University of Copenhagen), Copenhagen, Denmark
  • Martin-Luther-Universitaet Halle-Wittenberg, Halle (Saale), Germany
  • Stichting VU, Amsterdam, Netherlands
  • The University of Surrey, Guildford, United Kingdom
  • Universitat Konstanz, Konstanz, Germany
  • Universite De Lorraine, Nancy Cedex, France
  • Universiteit Leiden, Leiden, Netherlands
  • University of Lisboa, Faculty of Pharmacy (Faculdade de Farmácia da Universidade de Lisboa), Lisboa, Portugal
  • University of Liverpool, Liverpool, United Kingdom
  • Universität Wien, Vienna, Austria
  • Université Paris-Sud, Orsay, France
  • Uppsala universitet, Uppsala, Sweden
Small and medium-sized enterprises (SMEs)
  • Stichting Lygature, Utrecht, Netherlands

CONTACT

Project coordinator
Manfred Kansy
F. HOFFMANN-LA ROCHE AG
+41 61 688 5874
manfred.kansy[at]roche.com
Managing entity
Nico Vermeulen
STICHTING VU
+31 20 598 7590
n.p.e.vermeulen[at]vu.nl