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Detaljeret workshop-program for The Regulatory Journeys 1. workshop

The Regulatory Journey

Kick-off for Health Tech Start-ups

Date and Time: 20.9.2022, 09.00 – 16.00

Place: COBIS, Køpenhavn N

Participants:

  • Danish teams or start-ups selected to the program
  • Regulatory consultants and stakeholders from the start-up ecosystem
  • Business accelerators

This event is a kick-off into the Regulatory Journey service program. The concept is targeted for teams and start-ups that are in the ideation or early development phase of a product or software for the health care sector. The objective of the program is to provide the teams with the necessary baseline knowledge regarding regulatory compliance in order to save months’ worth of time and effort in reaching the market. The concept combines digital, training and coaching methods which will be employed in this kick-off event and throughout the following two months of the program.

While this is the first running of the program, attendees are will be engaged to provide active feedback for the organisers and the program will be further developed based on the feedback.

AGENDA

09.00-09.15    Coffee

09:15-9:30      Welcoming words, presenting the program.
/ Signe Ulrik Holm, Danish Life Science Cluster

09.30-10.00    Round table and interview with start-ups over their regulatory challenges, discussion, feedback, experiences, stumble blocks, expectations.
/ Christian Waarst, Accelerace

10.00-10.15    Presentation of the Regulatory Journey service concept, digital + training + workshop coaching. Discussion.
/ Heikki Pitkänen, Lean Entries

10.15-10.30    – – break – –

10.30-12.00    Regulatory Essentials in Health Tech Compliance as a Business Advantage, part 1.
What to focus on from Day One? Questions & Answers.
/ Heikki Pitkänen, Lean Entries

12.00-13.00    Lunch break

13.00-14.00    Regulatory Essentials in Health Tech Compliance as a Business Advantage, part 2. Continued. Questions & Answers.
/ Heikki Pitkänen, Lean Entries

14.00-15.00    Coaching sessions with consultants: Towards the realistic regulatory plan within the business plan.

15.00-15.30    Coffee and talk: Feedback from the attendees. Expectations from the program?

15.30-16.00    Handing over the tools and schedule for the next two months. Wrapping-up.