EUPATI Toolbox Starter Kits for Mini-Courses on Medicines R&D

Manual for Trainers: Using EUPATI Starter Kits for Mini-Courses based on the EUPATI Toolbox Material This presentation is a derivative of the EUPATI Toolbox by EUPATI used under CC BY-NC-SA 4.0. It is also licensed under CC BY-NC-SA.4.0

What is the EUPATI Toolbox on Medicines R&D? The EUPATI Toolbox on Medicines R&D at www.eupati.eu is the most elaborate web resource for lay people to inform themselves about all processes of medicines R&D. It provides texts, infographics, PPT slide decks and videos, all released under the Creative Commons License. The content is available in 14 languages (English, Danish, Dutch, French, German, Greek, Italian, Japanese, Polish, Portuguese, Romanian, Russian, Spanish, Swedish). To ensure the content is accurate, accessible and objective, it has gone through a complex process of authoring, review and validation These Starter Kits should support you in preparing short courses for patients and patient advocates, based on content from the Toolbox.

This starter kit provides you with resources to prepare and run mini-courses This Trainers' Manual, will introduce you to our starter kits and how to use them to prepare mini-courses. PowerPoint decks that you may re-use in your mini-course: o Core set of PPT slides, outlining a specific area of R&D and how patients can get involved o Additional links to EUPATI Toolbox resources, including links to Toolbox elements, example case studies and exercises Some guidance on how to select EUPATI Toolbox material that is most relevant for your specific mini-course: o e.g. how to find texts, slide sets, images and illustrations in the EUPATI Toolbox that you may want to use

The PPT decks of the EUPATI starter kits There are nine starter kits for the following areas of patient involvement in o Information & consent in clinical trials o Community Advisory Boards o Health Technology Assessment o Health Technology Assessment o Medicines safety o Setting research priorities o Ethics Committee o Data Monitoring Committees o Protocol design Regulation Each of the starter kits contains a selection of PPT slides which you may use to educate patients/advocates about the basics in that area, e.g. in a two-hour to one-day seminar. The starter kits are based on existing content from the EUPATI Toolbox, plus additional links to add-on Toolbox material. None of the starter kits are ready-made course modules they are a ready-to- reuse resource for an experienced trainer to prepare and execute a course. You will need to edit them and put them into context.

Nine starter kits for mini- courses are covering topics in the following areas Starter Kits: 1. Setting research priorities 2.Ethics Committees 3.Data Monitoring Committees 4.Trial Steering Committees 5.Protocol design 6.Medicines safety 7.Information & consent in clinical trials Community Advisory Boards 8.Health Technology Assessment 9.Health Technology Assessment Regulation R&D topics touched in these starter kits: Basics of Medicine Development Benefit and Risk Assessment Clinical Development and Trials Drug Discovery Health Technology Assessment Non-Clinical Studies Personalised Medicine Pharmaceutical Development Pharmacoepidemiology Regulatory Affairs Safety of Medicines Types of Medicines

Other things to consider when preparing your mini- courses Define the duration of your training o 2 hours? Half day? Full day? How much time for presentation, how much for Q&A? How many disease-specific issues would you add for your community?) Define the theme and objectives o Which topics are essential to be covered? Which are only optional? Define the learning outcomes - what should participants learn and take home? o Understand your target audience - Depth and spread of prior knowledge? Patients? Advocates? o What are their expectations? o Formulate the learning outcomes

Other things to consider when preparing your mini- courses Prepare the content oDefine depth and complexity oIdentify the material you want to use to prepare the course, prioritize, then work out in detail Plan the course logistics oDo you need audio-visuals, technology, flip-charts, moderation material, Internet connection etc. to facilitate interaction? Familiarize yourself comprehensively with the topic and available resources oThe processes of medicines R&D oThe underlying regulatory background oExisting initiatives in advocacy and capacity building in the respective topic areas oThe breadth and depth of Toolbox content and media available on www.eupati.eu

Suggestions when creating PPTs based on EUPATI Toolbox material Always use the EUPATI PPT template to start with (like this one). This allows easy re-use of slides in all EUPATI-based slide decks. Always create new slides based on the EUPATI master slide deck, use function New Slide Title and Content slide Try not to change font sizes, fonts, background and font colours etc. If you must, don t use font sizes below 14pt. Make sure you refer to the Creative Commons License correctly This presentation is a derivative of the article _____ [link] by EUPATI used under CC BY-NC-SA 4.0. It is also licensed under CC BY-NC-SA.4.0

Suggestions when creating PPTs based on EUPATI Toolbox material Use an external tool, such as Mentimeter to create an interactive quiz and deliver an engaging training session. Questions/ statements to include in the Mentimeter quiz: o Please rate your level of satisfaction with the following: - One key takeaway from the course - Your favourite part of the course - Additional questions

Suggestions when creating PPTs based on EUPATI Toolbox material ICON Library: Feel free to copy with pride, change color and add more icons if you like.

Remember: YOUR course is also subject to the Creative Commons License! Remember that all content provided by EUPATI is based on the Creative Commons License, which also applies to all derivatives of it! Therefore o You must state the license in your course material. o You must also release your course material under Creative Commons when using EUPATI material. Example if you have not changed anything: Phases of Clinical Development by EUPATI is licensed under CC BY-NC-SA 4.0. Example if you have changed something: My clinical trials guide is a derivative of Phases of Clinical Development by EUPATI used under CC BY-NC-SA 4.0. My clinical trials guide is licensed under CC BY-NC-SA 4.0 by Matthew.

Questions? Suggestions? Feedback? Please get in touch with the EUPATI Team. Please let us know how you are using the Starter Kits, and share the successes and challenges you experience, or if you miss something while preparing your mini-course. We will try to help you if you experience challenges. We strive to improve the EUPATI Starter Kits for the EUPATI Toolbox, based on your feedback. Please contact us at info@eupati.eu or via www.eupati.eu