NLS Invest Workshop 1

Workshop by NDA Group - Navigating a Proactive Approach to Regulations

19 April 2021

10:30 - 11:30
Workshop by NDA Group - Navigating a Proactive Approach to Regulations

NLS Invest Workshop 1

10:30 - 11:30

The path to approval is littered with pitfalls, leading to unnecessary delays in getting your products to the people who need it the most: the patients. Such delays inevitably cost not only time, but extraordinary amounts of money. The first part of this workshop will showcase how creating a regulatory roadmap for all required regulatory interactions will not only help you to plan meetings with relevant agencies, but will also prepare you for the requirements, cost, and time required to reach regulatory milestones throughout your drug development. The ability to avoid unnecessary delays allows you to properly prepare, as well as to show your investors that you are informed and addressing each stage of development. Separately, but equally important, the deadline for the EU Medical Device Regulation (MDR) is fast approaching, bringing with it a host of new challenges to manufacturers in the European market. Failure to understand the implications of these changes can result in losing certification and, therefore, the right to place your medical devices on the EU market. The second part of this workshop will thus outline several, specific challenges coming with MDR and will prepare you to tackle those challenges head-on.

Sponsored by:

NDA Group

NDA Group

Speaker(s):

Dr. Tina Amini - Medical Device Division Director, NDA Group
Dr. Björn Carlsson - Principal Consultant, NDA Group
Dr. Steffen Thirstrup - Director, NDA Regulatory Advisory Board, NDA Advisory Services

full program