HealthTech & Pharma – Opportunities and challenges of Regulations, AI and Sustainability, 27.1.2025, Kuopio
- Begins:
- 27.1.2025
- Credits:
- 0
- Location:
- Kuopio
- Continuous learning category:
- Social welfare and health care, Technology and digitalization
- Teaching format:
- Contact teaching
- Price:
- 0 € (VAT 0%)
During the training day we will
- familiarize ourselves with the requirements and opportunities brought to the sector by the regulation of artificial intelligence (AI).
- learn about the responsible use of AI.
- learn what kind of data is needed for effective and responsible decision-making.
- discuss how we can succeed in combining ecological, social and economic sustainability at work or in everyday life.
- network and exchange ideas with colleagues.
In the afternoon, we will have three parallel workshops. In these workshops we get tips for sustainability actions, show how to take a next step in the regulation strategy of MDs/IVDs, and take insight into current issues in clinical studies of MDs/IVDs and pharmaceuticals.
In addition to the informative lectures, you can promote your wellbeing and sustainability skills by participating in free wellness activities.
Register for the training day by Monday 20.1.2025 at the latest.
Come and join us in Kuopio in the closing seminar of the ReguVa project!
- Personnel of pharmaceutical, diagnostic and health technology companies, research service companies (e.g. CROs) and pharmacies
- Staff of wellbeing service counties, research institutes and regulatory authorities e.g. Fimea
- Researchers, students and staff of Universities and Universities of Applied Sciences
- Investors
- Especially suitable for management, quality and regulatory affairs professionals and those responsible for public affairs
Monday, 27 January 2025, at 9.00 – 16.00.
University of Eastern Finland, Kuopio Campus Tietoteknia building, Auditorium (Savilahdentie 6 B, 70210 Kuopio)
Registrations by 20.1.2025!
Free training. The ReguVa project is co-funded by the European Union.
Before the day you can submit questions for the speakers. You will also receive access to the pre-training material:
- “Responsibility as part of the lifecycle management of a medical device”-recording by Sandra Liede, Senior Legal Specialist, Healthtech Finland (Terveysteknologia ry)
More information in January 2025.
During lunch and coffee breaks promote your wellbeing by participating in the wellness activities. In addition, you can learn more about other projects and continuous learning possibilities in a Skills for good -clinic.
Below you can find a list of the activities:
1. “Pidä huolta” sing-along
Join in singing together and energize your day to the tune of the song “Pidä Huolta”.
2. Knitting and repairing clinic
Permission to knit and repair clothes granted ! Take your knitting work with you and let’s enjoy knitting together during the seminar. Take a picture of it before and after the seminar and share it in LinkedIn with #ReguVa. Bring a holey wool sock with you and get tips from our repairing clinic.
3. One man's trash is another's treasure!
Bring something you no longer need (e.g. an unbroken toy or a garment) to our recycling point. You can also pick up what you need from there. Yarn circulates – you can bring the yarn collections that need to be recycled with you, we will knit them to help those in need during the seminar or donate them further.
4. “Happy Together” prize lottery
Win a “Happy together” painting on your wall! The painting was made during the ReguVa project.
5. Small Eco-Acts of Everyday Life
Get inspired by the videos of small eco-acts in everyday life
https://vimeo.com/showcase/10715381
9:00 – 9:15 Registration
9:15 – 9:30 Welcome to the Seminar!
Chair of the session Jarkko Ketolainen, Head of the Department, Professor, School of Pharmacy, UEF
9:30 – 9:50 New skills and benefits from participating the ReguVa project
Tiina Kotipalo, Head of Quality and Development, Medanets
9:50 – 10:30 Where are we with the AI regulation?
- What are the relevant AIA risk categories for healthtech?
- Current developments at national level
Sandra Liede, Senior Legal Specialist, Healthtech Finland (Terveysteknologia ry)
10:30 – 10:45 Break for movement
10:45 – 11:20 Responsible AI - identifying and managing AI risk in healthcare
Antti Kaltiainen, CTO, Innokas Medicals Oy
11:20 – 11:50 Responsible decision making with the data from the effectiveness studies
Erkki Soini. CEO, ESiOR Oy. Chairman of the Board, Kuopio Health
11:50 – 13:00 Lunch (self-paid) and participating in wellness activities and in a Skills for good -clinic
13:00 – 13:45 Panel Discussion: A sustainable choice or a reasonable compromise?
How to successfully combine the different areas of sustainability in decision-making and the everyday life of the organization?
klo 13:45 – 14:00 Pidä huolta sing-along
14:00 – 14:30 Coffee break and networking with colleagues in a Skills for good -clinic
Parallel workshops in the afternoon
14:30 – 16:00 Parallel workshops
1. Tips for Sustainbility Actions
The content will be updated soon.
2. The Next step in the regulation strategy of MDs/IVDs
The content will be updated soon.
3. Hot topics of clinical studies of MDs/IVDs and pharmaceuticals
The content will be updated soon.
Instructor
Sandra Liede
Leading senior legal specialist
Healthtech Finland
Sandra Liede acts as the leading senior legal specialist at Healthtech Finland. She supports the association's member companies by answering their regulatory questions. She has 15 years of experience in ethical and legal issues in the health sector and a background in industry governance, law drafting and various positions of trust. Sandra has experience of working with both national and EU-level decision-makers.
Antti Kaltiainen
CTO
Innokas Medical Oy
Antti Kaltiainen works as Chief Technology Officer in software development at Innokas Medical. He has 25 years of experience in various positions in software and embedded systems product development. Kaltiainen has worked the last 7 years as a CTO and advisor to companies focused on IoT and machine learning. In his work, Kaltainen follows the latest technologies and defines solutions for regulated medical software for Innokas' customers. For the past few years, he has also been an advisor on artificial intelligence in health technology in the IEC’s "Software Network and Artificial Intelligence advisory Group" under the committee of IEC TC 62.
Erkki Soini
CEO, Chairman of the Board at Kuopio Health
ESiOR Oy
Erkki Soini is a professional health economist that has extensive experience in health technology assessment, market access, real-world evidence (RWE), and secure processing environment (SPESiOR) as well as industry, health care, and public-private-partnerships. He is multiple times internationally awarded content producer in health economics, pharmacoeconomics, outcomes research, and data mining. Erkki Soini has shared expertise e.g., as an advisor in a Current Care Working Group and TEHDAS (Joint Action Towards the European Health Data Space). He has served as a scientific review committee chair of European ISPOR congress twice. His key interests include effectiveness, cost-effectiveness, and value of information. Erkki Soini has taken part in 700+ projects, 280+ public references, and 80+ scientific articles.
Tiina Kotipalo
Head of Quality and Development
Medanets
Tiina Kotipalo works at Medanets Oy as the Head of Quality and Development. She has over 20 years of experience in the development, manufacturing, and quality management of medical devices, as well as in ensuring compliance with various quality and regulatory requirements. At Medanets, she leads the company’s quality processes, ensuring the safety and compliance of applications with both EU and international quality management and regulatory standards.
Jarkko Ketolainen
Head of Department, Professor
School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland
Jarkko Ketolainen (PhD Pharm, Professor in Pharmaceutical Technology since 2000 ) has been working as the Head of School at the School of Pharmacy in the University of Eastern Finland since the year 2015. He has a strong background in pharmaceutical manufacturing related process and his current research focuses on the manufacturing of solid dosage forms, with a particular emphasis on resource-efficient pharmaceutical production, such as continuous manufacturing. Furthermore, Professor Ketolainen has been a member and 2nd vice chair of the Academy of Finland’s Research Council for Health (2013 -2018). In addition, he has been a member of EUFEPS’ (European Federation for Pharmaceutical Sciences) QbD and PAT Sciences Network Steering Group since 2007. Professor Ketolainen was also the director of PROMIS Centre (a R&D centre comprised of UEF pharmacy and physics, VTT, Savonia and over 30 partnering companies international and national). Professor Ketolainen has also entrepreneurial background from late 90’s to early 2000’s (e.g. managing director of Oy MedFiles Pharma Ltd. 2000 – 2002).
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