Aligning clinical evidence and market access for your medical device

The manufacturer´s focus during the medical device life-cycle is to continuously ensure safety and performance of the device, this is done by iterating/ updating the technical documents such as the clinical evaluation and risk management regularly and when triggered.

Collecting clinical data by investigations is time consuming and costly. Market access is not only dependent on regulatory compliance but in addition expectations and requirements from a health economic perspective is generally needed.

Understanding the need for such expectations early on in the process of collecting your clinical data is imperative. During the event ways to include not only a regulatory strategy but also a clinical strategy will be discussed. Challenges, solutions and lessons learned both from European and US market will be shared. Success stories and facilitating tips for how to handle regulatory compliance, the clinical evaluation and post- market surveillance/ PMCFs is on the agenda.

The aim of this meeting is to provide the basis for knowledge sharing and a fruitful dialogue on how you may align clinical data collection and market access for your medical device.

Date: Thursday 21st March 2024
Time: 14.00 – 18.00
Venue: Medicon Village, Auditorium, Building Inspira, Scheelevägen 4, Lund, Sweden

SIGN UP

Program

Deadline for registration is 19th March, 2024.

SPEAKERS​

	Maria Lindgren is Director of Clinical Strategy at Key2Compliance® and has more than 20 years´ experience from the medical device and pharmaceutical industries. Prior to joining Key2Compliance® Maria worked for Sigrid Therapeutics AB, Modus Therapeutics AB and as a research scientist as well as teacher/seminar holder of several courses at Stockholm University. She has worked with drug and medical device development and research, production/CMC, medical writing, quality and regulatory documentation. Her main expertise lies within clinical evaluation and clinical investigations of medical devices, mainly from a start-up/biotech perspective.
	Annelie Aava Vikner holds a bachelor’s degree in chemistry from the Linköping Institute of Technology (Linköping University). Over the past 28 years, she has assumed several leadership roles in the pharmaceutical and medical technology industries, primarily in marketing but also in sales and clinical trials. With a strong commitment to driving innovation, Annelie brings expertise in developing marketing strategies and spearheading launches of cutting-edge medical innovations across diverse specialties and global markets. Since 2019, she has been serving as the Executive Vice President, Global Marketing, at BONESUPPORT.
	Louise Hansen holds a Master in Medicine with Industrial Specialisation from Aalborg University and a PhD in health economics. Louise has worked with health economics and market access of health technology for the past 12 years. Louise is the national coordinator in Trial Nation for MedTech studies in Denmark. Trial Nation continuously work on improving the ecosystem on clinical trials and investigations with both member organisations and collaborators.
	Jan Hellqvist has worked in Leadership positions within Global and Local Pharma, Medical Device, Diagnostics, Contract Research, Consultancy and Training & Education for more than thirty years. He has experience from leading Companies like AstraZeneca, Stryker, Orifarm, Dako Agilent, TFS and KLIFO. Jan has now been the CEO of Key2Compliance for more than four years.

Medicon Valley Alliance Medtech Network gathers the region’s medtech industry to create new partnerships and business opportunities. Joining the network is free of charge for Medicon Valley Alliance members interested in gaining new insights, sharing experiences and networking with like-minded organisations. Non-member organisations and companies are welcome to attend one network event to evaluate membership.

Organized by	Host