Drug safety is an extremely important part of the drug development process. Yet, prior to the launch of IMI’s SafeSciMET project in 2010, educational and training programmes in drug safety science in Europe were scarce. IMI’s SafeSciMET project addressed this gap successfully.
By bringing together 16 academic institutions and 14 pharmaceutical companies, the project developed a curriculum of 20 courses which cover topics along the whole trajectory of drug safety sciences, from developing a drug candidate, through testing it in laboratory studies, and all the way to bringing it to the patient. Professionals can follow single courses in safety sciences or selected subsets of courses, and be accredited for continuing professional development. Furthermore, students successfully completing the full training programme, including a master’s thesis, get awarded with an accredited master’s degree from the University of Konstanz in Germany, one of the project partners.
The SafeSciMET courses are open to scientists from industry, academia and regulatory agencies, and encompass the safety, ethical, regulatory and societal aspects of drug discovery and development. About 800 students have been trained so far: about 40% of them came from the pharmaceutical industry, 35% from academia and 10% from regulatory offices.
Courses adapted to real-life industry needs
Each course has a course leader from industry and academia, and in addition to the theoretical knowledge, contains real-life case studies from industry partners. Thanks to this public-private collaboration, the project created a unique pan-European training network of more than 200 course leaders and teachers from both industry and academia.
SafeSciMET training is already leading to a new generation of safety specialists with strong competences in the application of novel technologies in risk assessment. The hope is that thanks to this unique programme, they will be able to perform reliable evaluations of the safety of drug candidates and new medicines in a more effective way. This could in turn speed up biopharmaceutical innovation and may eventually lead to a cost reduction in drug development.
For the benefit of industry and academia
Thanks to the SafeSciMET programme, the pharmaceutical industry got access to a new breed of trained professionals who are better positioned to address challenges in drug development and safety.
The academic partners benefited from the pharmaceutical companies’ expertise in drug safety sciences, which helped them design courses that are more in tune with the real-life needs of the industry. As a result, students trained through this programme have been getting easier access to jobs in the industry.
Both industry and academic project partners are also benefiting from the pan-European network of safety science educators and experts which was established through this project.
During the course of the project, three course cycles were held. After the end of the project, the project partners managed to set up a short-term sustainability plan thanks to which a fourth course will run in 2017 and 2018. This and future course cycles are coordinated and managed by the University of Konstanz.
Read the interview with project coordinators
Achievements & News
IMI’s SafeSciMET project established a much-needed education and training programme in drug safety sciences in Europe. In an interview with the IMI Programme Office, project coordinators Manfred Kansy of Roche and Nico Vermeulen of the Vrije Universiteit Amsterdam explain how this project will contribute to developing safer medicines in the future. ### ‘It is remarkable that we succeeded within the first year already to put together a curriculum for 20 courses which were harmonised with each other. In the second year we already started giving the courses,’ said Vermeulen. ‘It just amazes me that we managed to bring all these people together in one consortium, in one curriculum.’ Added Kansy: ‘What is amazing is that in the three course cycles which we had, more than 800 people have been trained. I think this is quite an achievement.’ Read the full interview
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.
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)
- Innovative in vitro models in drug safety assessments – 13-16 September 2016, Liverpool (UK)
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.
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.
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.
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.
IMI and the IMI Education & Training projects will participate in BIOVISION - the World Life Sciences Forum, which will be held in Lyon, France, on March 24-26 2013.### It is the place where key stakeholders can 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 will participate in the plenary session ‘How to make better use of collective intelligence’. Mike Hardman, project coordinator of EMTRAIN, will represent IMI and the IMI E&T projects in the BIOVISION Investor Conference workshop. Moreover, the IMI E&T projects are organising a satellite event on ‘Training and Education in Europe’ where they will present their activities to the forum’s participants at a booth in the exhibition area.
This year’s DIA EuroMeeting, which will be held in Amsterdam, the Netherlands from 4 to 6 March, features an entire theme dedicated to IMI’s five Education & Training (E&T) projects.### The sessions will feature the latest news from the projects and demonstrate how they are helping to advance education in the biomedical sector in Europe. DIA EuroMeeting visitors can also catch up with the projects and find out how IMI’s E&T projects can boost their careers at Booth 918 in the exhibition area.
- View the agenda for the IMI theme in the DIA EuroMeeting programme (page 46)
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.
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.
IMI Education and Training project SafeSciMET is launching three new courses in the area of clinical safety. The course ‘Clinical safety: pre-approval’ will run 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’ will run on 27-31 August in Stockholm, Sweden. Applications for the new courses are now open via the project website. Meanwhile, the deadline for applications is looming for two other SafeSciMET courses: ‘Toxicogenomics and systems toxicology’ (deadline 12 March) and ‘Pathology interpretation in drug development’ (deadline 16 March). SafeSciMET courses feature lectures by experts from both academia and industry, with case studies drawn from industry. Courses can be taken individually or combined to work towards a diploma or Master degree in safety science.
If your new year’s resolution is to boost your career by following some courses, then why not check out the courses run by IMI project SafeSciMET, the new pan-European programme on safety sciences.### Applications are currently open for courses on ‘safety pharmacology’; ‘non-clinical safety assessment: strategies, ethics and protocols’; ‘biomolecular analysis: from method development to clinic’; and ‘predictive cell culture systems’, among others. SafeSciMET’s modular structure allows scientists to choose the courses that match their needs. Attending the full programme leads to an Advanced Master’s degree in Safety Sciences. Feedback from the first round of courses held in 2011 has been very positive; with students commenting: ‘The course has exceeded my expectations’, and ‘I was very pleased with the structure, the content, and the quality of the presentations and the preparedness of the presenters’.
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.
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)
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)
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'.
ParticipantsShow participants on map
- Almirall SA, Barcelona, Spain
- Astrazeneca AB, Södertälje, Sweden
- Bayer Pharma AG, Berlin, Germany
- Boehringer Ingelheim Internationalgmbh, Ingelheim, Germany
- Eli Lilly And Company LTD, Basingstoke, United Kingdom
- F. Hoffmann-La Roche AG, Basel, Switzerland
- Glaxosmithkline Research And Development LTD., Brentford, Middlesex, United Kingdom
- H. Lundbeck As, Valby, Denmark
- Merck Kommanditgesellschaft Auf Aktien, Darmstadt, Germany
- Novartis Pharma AG, Basel, Switzerland
- Novo Nordisk A/S, Bagsvaerd, Denmark
- Orion Oyj, Espoo, Finland
- Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
- UCB Biopharma, Brussels, Belgium
Universities, research organisations, public bodies, non-profit groups
- Charite - Universitaetsmedizin Berlin, Berlin, Germany
- European Federation For Pharmaceutical Sciences, Järfälla, Stockholm, Sweden
- Hospices Civils De Lyon, lyon, France
- Karolinska Institutet, Stockholm, Sweden
- Kobenhavns Universitet, Copenhagen, Denmark
- Martin-Luther-Universitat Halle-Wittenberg, Halle (Saale), Germany
- Stichting Lygature, Utrecht, Netherlands
- Stichting Vu, Amsterdam, Netherlands
- The University Of Liverpool, Liverpool, United Kingdom
- Universitat Konstanz, Konstanz, Germany
- Universitat Wien, Vienna, Austria
- Universite De Lorraine, Nancy Cedex, France
- Universite Paris-Sud, Orsay, France
- Universiteit Leiden, Leiden, Netherlands
- University Of Surrey, Guildford, United Kingdom
- University of Lisboa, Faculty of Pharmacy (Faculdade de Farmácia da Universidade de Lisboa), Lisboa, Portugal
- Uppsala Universitet, Uppsala, Sweden
|Name||IHI funding in €|
|Charite - Universitaetsmedizin Berlin||18 315|
|European Federation For Pharmaceutical Sciences||231 400|
|Hospices Civils De Lyon||26 027|
|Karolinska Institutet||21 400|
|Kobenhavns Universitet||52 200|
|Martin-Luther-Universitat Halle-Wittenberg||21 800|
|Stichting Lygature||20 727|
|Stichting Vu||767 305|
|The University Of Liverpool||27 225|
|Universitat Konstanz||531 300|
|Universitat Wien||34 800|
|Universite De Lorraine||1 665|
|Universite Paris-Sud||2 340|
|Universiteit Leiden||64 300|
|University of Lisboa, Faculty of Pharmacy (Faculdade de Farmácia da Universidade de Lisboa)||20 727|
|University Of Surrey||47 867|
|Uppsala Universitet||485 506|
|Total Cost||2 374 904|