Join PCG Clinical Services and QAdvis for a half-day Medical Device seminar followed by a lunch mingle at Kista Entré on June 1st. The seminar will outline the new Medical Device Regulations (MDR 2017/745) and in-vitro Diagnostic Regulations (IVDR 2017/746) that will come in effect over the next two to four years. PCG and QAdvis will present strategies and opportunities to navigate through these new requirements. The seminar will explore clinical evaluation and clinical performance evaluation regulations as well as clinical investigation techniques for both before and after CE-marking.
QAdvis is a long time trusted provider of medical device regulatory services and PCG Clinical Services is a full-service CRO committed to improving clinical investigations through our scientific expertise, progressive technology and more effective ways of working.
Presentations and Q&A are verbally held in Swedish. View our agenda and register before seats run out!
Agenda:
08:15 – 08:45
Registration and coffee
08:45 – 08.50
Welcome to the PCG & QAdvis advantage (PCG)
08:50 - 09:10 QAdvis
Intro to the MDR & IVDR news
• Key challenges
09:10 – 10:00 QAdvis
• Clinical evaluation according to MDR
• Clinical performance evaluation according to IVDR
10:00 – 10:15
Fika break
10:15 – 11:00 PCG
• Clinical investigations/ clinical performance
• Design/Viedoc
• Importance of Biometrics
• The PCG solution
11:00-11.10 (PCG & QAdvis)
Summary, PCG & QAdvis advantage
11:10-11.30 Q&A (All)
Lunch mingle
We look forward to seeing you here!
Speakers
Cecilia Emanuelsson, Principal Consultant - QAdvis
Cecilia has extensive experience from the medical device industry together with a strong academic record – a combination well suited for covering all aspects of clinical evaluation / clinical performance evaluation. Cecilia holds a PhD from the Medical faculty at Uppsala university.
Robert Ginsberg, Principal Consultant and Chairman of the Board
Robert specializes in software regulatory issues relating to medical devices and modern software engineering methods. He has through the years worked with resolving potential issues with aligning the regulations and iterative software development methods. Robert has a physics/engineering background, and has implemented modern software engineering methods at several medical device companies, large as small. He has the last 15 years been an active member of international standardization committee, ISO and IEC. Robert is Chairman of board at QAdvis and is currently working as a consultant helping medical device companies finding cost effective implementation of regulations for medical device software. Robert has a MSc in Engineering Physics from Uppsala University.
Maria Axetun Project Management Viedoc Trials, PCG Clinical Services
Maria Axetun joined PCG Clinical Services in 2016 and her current position is Project Manager in Viedoc Trials. She has almost ten years of experience within all phases of clinical trials and clinical investigations. Her expertise is eCRF design/setup and EDC administration, but she has also great experience in process development, data validation, programming, coding, clean file and quality control. Maria contributes with input to the design of the eCRF to get the best value of the data collected.
Daniel Seisdedos, Clinical Project Manager, PCG Clinical Services
Daniel Seisdedos, Clinical Project Manager and PCG Clinical Services’ Safety Team Lead. Daniel’s experience covers all phases of clinical investigations and trials from first in man to post marketing and includes many different roles and functions like Monitoring & Project Management.
Daniel joined PCG Clinical Services ten (10) years ago and has grown together with the company. Daniels strength is his deep understanding of the clinical trial setting and to communicate with small companies, guiding them through the sometimes-complicated world of clinical trials.
Antonio Mastroianni, Business Developer at PCG Clinical Services
Antonio has 20 years of multi-sector experience in government, non-profit, standard-setting bodies, and for-profit organizations. Over the course of working with various organizations across the US and Europe Antonio has specialized in IT/Telecom management consulting and Healthcare. His primary focus today with PCG Clinical Service is in partnership management, business development, and transformation.
Medicon Village complex map
How to get here:
Kista Entré
Conference room: Sigma
Tunnelbana
Tag linje 11 Kungsträdsgården - Akalla. Restid ca 20 minuter från T-Centralen.
Gå av vid Kista (bakre utgången mot Kista Galleria). Följ Kistagången till vänster genom Kista Galleria och följ sedan nedanstående beskrivning "Gångväg från Kista Galleria".
Pendeltåg
Åk linjen Södertälje - Märsta, hoppa av vid Station Helenelund (J). Restid från Centralen är ca 15 minuter.
Från Helenelund kan man antingen gå eller ta någon av många bussar som stannar i Kista.
Gångväg från Kista Galleria
Följ skyltar mot Kista Science Tower som du kommer att gå rakt igenom och sedan komma ut på andra sidan vid Sats. Tag vänster när du kommer ut, gå över gångbron och sväng sedan höger. Nu har du vår stora entré rakt framför dig.
Bilväg
Från Stockholm
Åk E4:an mot Uppsala, sväng av vid Kista S. Följ skylt mot Kista, vänster in på Kymlingelänken (väg 279). Följ skylt mot Kista Företagsområde, ta därefter första avfarten till höger i rondellen in på Torshamnsgatan. Tag av andra vägen till vänster, Kistavägen. Sväng längre fram till höger in på Isafjordsgatan och därefter direkt vänster in på Knarrarnäsgatan. Ingången till Kista Entré Konferens ligger till vänster nere i vinkeln på huset.
Flygbuss
Arlanda - Kista - Brommaplan. Tidtabell via www.flygbussarna.se