One country, one set of rules. When deciding to access a market or complying with new regulations, the job proves to be sometimes difficult for medtech companies and a clear strategy must be put in place. The discussions in this track will focus on the advantages and disadvantages of established vs emerging markets and the impact on innovation of complying with new regulations.
ACCESSING INTERNATIONAL MARKETS: HOW TO CRACK THE CODE?
Part 1 – Navigating through the European and the Israeli markets – 26th June 2018 | 4:30 pm
Part 2 – Accessing Canadian market: meet the key players – 27th June 2018 | 9:00 am
Each country has its own set of rules. Accessing different markets means adapting your strategy to comply with completely different processes and requirements. The main factors resulting in varieties in market access are: the process of getting reimbursed for product use, the DRG systems’ support of or the resistance to adopting new technologies, and the complexity and duration of the licensing and regulatory tracks.
These workshops will focus on how to adapt your strategy to the target market, how to overcome hurdles, and offer advice on how best to comply with the country’s regulations and licensing and reimbursement processes. It will also be an opportunity to meet key local stakeholders and understand local medtech ecosystems.
WHAT IMPACT DO GDPR & DATA PROTECTION IN MEDTECH AND DIAGNOSTICS HAVE ON INNOVATION
27th June 2018 | 9:00 am
Designed to strengthen existing data protection, the GDPR has a significant impact, placing new obligations on medtech businesses as far as handling highly sensitive patient information is concerned. In fact, the GDPR states that collecting data from and for clinical trials increases the risk of the freedoms and rights of natural persons being infringed upon.
Since medtech companies require extensive preparation to adjust their data protection to new standards, and considering the mandatory nature of those standards as well as the looming penalties imposed on non-compliant businesses, how will the implementation of the new regulations affect innovation in medtech?
#GDPR&DataProtection #NewRegulations #Compliance #Innovation