Courses > Short Focused Programs > 4. Medical Devices II: Market Access

— 4. Medical Devices II: Market Access


Short Description

This pack of lectures provides knowledge about the main elements to consider and work with when introducing a  medtech product into the market, including the development of health technology assessment, the definition of market access strategies and knowledge of the regulatory pathways, from both a European and a US perspective. What should I demonstrate about my product? Who should I contact to introduce my product into the hospital? Should I patent it in the US or in the EU first?


4.1 Medical Devices Regulation (double session)

Lecturer: Luis Soensken
Date
:
May 24, 2017
Time
: 
11:30 am – 1:30 pm and  3:00 pm – 5pm
Price
: 150 euros

Course outline: This course consists of two parts and will provide information about the regulation of medical devices, specifically in comparison to the pharmaceutical process, and with regard to the United States market, under Multiple Technology Appraisal (MTA) guidance. Luis Soenksen will increase our knowledge about the regulatory approval required from the Food and Drug Administration (FDA) in the USA. You will also take an in-depth look at the European regulatory process under the CE Marking process, and the key differences between both approvals. International regulation on medical devices for other regions such as South America, Asia and the Middle East is also presented. Numerous products and case studies will be covered. 


4.2 Reimbursement Basics 


Lecturer: 
Belen Martí
Date: September 20, 2017
Time: 3 pm - 5 pm
Price: 100 euros
Course outline: The objective of this session is to teach attendees the fundamental principles of European reimbursement and health economics, so that they understand the importance of it in health innovations from the very first day.


4.3 Health Technology Assessment


Lecturer: Laura Sampietro
Date: September 6, 2017
Time: 3 pm - 5 pm
Price: 100 euros
Course outline: This session is a very useful introduction to the healthcare value chain. and will teach you how to bring an idea into the market. Some of the topics that will be covered are: economic context, healthcare paradigm, healthcare technology life cycle, the basis of market approval and quality analysis, etc. You will learn the basic steps of HTA (Health Technology Assessment) and what is considered value in this specific market.


4.4  Market Access, Reimbursement Strategy and Implementation

Lecturer: Meike Bomhof
Date: September 7, 2017
Time: 10 am - 1 pm
Price: 130 euros
Course outline: This lesson covers reimbursement, which is a key process in the medtech sector. The lecturer explains what reimbursement is, the difference between countries in terms of reimbursement strategies, and the implementation strategies available to medtech start-ups.


PROMOTIONS

We offer a 50% discount (for any category, but not accumulative) to students who are in their final academic year at university, or who are studying a Masters degree related to the following fields: business, engineering, life sciences or design. If interested, please send an e-mail to lrogel@biocat.cat, with the subject "Short Programs Discount", providing your details and attaching a copy of your university registration. Promotions are limited and will be assigned on a first-come, first-served basis.


CANCELLATION POLICY 

To withdraw from a session you must send an e-mail to: lrogel@biocat.cat. If cancellation is received more than one week (7 working days) before the date of the Short Program session, you will be reimbursed for 100% of the registration fee. If cancellation is received during the week prior to the date of the lesson, you will be reimbursed for 50% of the registration fee. If no notice is given, participants will not be reimbursed even if they do not attend the session.

NUMBER OF SESSIONS: 4

DATES: From: 24th May 2017; Until: 7th September 2017

MODALITY: Whole package or individual sessions

PRICE: Whole package: 432 euros  (with a 10% of discount added);
Buy one or more sessions: price varies depending on the session

VENUE: PCB - Barcelona Science Park, C/ Baldiri Reixac 4-8, 08028 Barcelona

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