Enterprise training

66. BioCon Valley®-Trefftl_files/downloads/workshops_Germany/66.BCV Treff FDA WS HRO 03.12.2013/image001.gif
TRAINING-WORKSHOP for “MedTech Companies Interested in Entering the US Market”

3rd December 2013, Rostock-Warnemünde, Germany

Der US-Markt ist mit einem Volumen von 120.4 Milliarden US$ im Jahr 2012 der größte Medizinprodukt- und Medizintechnikmarkt der Welt. Zunehmend gewinnt dieser Markt auch für Hersteller aus Deutschland an Bedeutung, da auch in den USA das Qualitätslabel „Made in Germany“ stark nachgefragt wird. Die führenden US-Medizintechnik-Cluster sind in einer Handvoll von Bundesstaaten wie Kalifornien und Minnesota konzentriert. Minnesota als Mekka der Medizintechnik ist eine der weltweit größten Regionen der Life Science Produktion, mit mehr als 600 Firmen, wie beispielsweise 3M, Medtronic und St. Jude Medical. Die Zulassung von Medizinprodukten für den US-Markt wird durch die Federal Drug Agency FDA reguliert Es gibt im Wesentlichen zwei Möglichkeiten der Zulassung von Medizinprodukten. Für gesundheitlich kritische Produkte wie beispielsweise Herzschrittmacher werden von der FDA klinische Prüfungen vorgeschrieben.

Hier finden Sie den Programmflyer

Präsentationen zu den Vorträgen:

Training module „Internal Auditor of Enviromental System”, Rerun

26-27.11.2012, PUM Szczecin, Poland

Department of Genetics of Patomorfology from Pomeranian Medical Univeristy organized a rerun of the two days training module on 26thand 27th November. The training was entitled “Internal Auditor of Environmental Management System” and was dedicated to employees of health care service and people responsible for enviromantal protecyion. The training lasted two days, eight hours per day (16 hours)  and the company responsible for conducting it was Incert LtD.

Project partner 2 decided to organize the reedition of the traing, which was firstly held on 17th -18th  September due to large interest in this topic and requests from health care employees.

The aim of the training was to familiarize participants with the requirements of ISO 14001. ISO 14001 is environmental management standard which specifies a set of environmental management requirements for environmental management systems. The purpose of this standard is to help all types of organizations to protect the environment, to prevent pollution, and to improve their environmental performance. During the course requirements of ISO 14001 and methods of its interpretation were discussed in details. Particular attention was payed to areas of outstanding environmental management system in relation to other management systems, ie, the identification of environmental aspects, setting objectives and targets, environmental program management and implementation of effective controls and to ensure preparedness and response in case of emergency. Participants were also told how to organize and conduct internal audit. At the end of the training module participants who past the test, gained a certificate of Internal Auditor of Environmental Management System. The content of the training module can be found on Eco4Life website.

Invitation

Environmental management 01

Environmental management 02

Environmental management 03

Environmental management 04

Training module “Internal Auditor of Environmental Management System”

September 2012, PUM Szczecin, Poland

Department of Genetics and Pathomorfology from Pomeranian Medical University in Szczecin organized two-days training module as a part of the project “Eco4Life - South Baltic Network for Environmental and Life Sciences is a Boost Cross Border Cooperation”. The training was entitled “Internal Auditor of Environmental Management System” and dedicated to employees of health care service. The training was held during 17 th and 18 th  September.

The aim of the training was to familiarize participants with the requirements of ISO 14001. ISO 14001 is environmental management standard which specifies a set of environmental management requirements for environmental management systems. The purpose of this standard is to help all types of organizations to protect the environment, to prevent pollution, and to improve their environmental performance. During the course requirements of ISO 14001 and methods of its interpretation were discussed in details. Particular attention was payed to areas of outstanding environmental management system in relation to other management systems, ie, the identification of environmental aspects, setting objectives and targets, environmental program management and implementation of effective controls and to ensure preparedness and response in case of emergency. Participants were also told how to organize and conduct internal audit. At the end of the training module participants gained a certificate of Internal Auditor of Environmental Management System.

Environmental management 01

Environmental management 02

Environmental management 03

Environmental management 04

EU research management: "How to prepare a research proposal and manage it"

November 2011, University Klaipeda, Lithuania

Eco4Life will organize 3 training modules within the Project life cycle. First one took place in Klaipeda on the topic. “EU research management: how to prepare a research proposal and manage it”.

Aining duration: 14-15 November 2011

The first part of lecture has been video-transmitted to Poland (Szczecin) and Germany (Greifswald). The number of participants was 17. Training participants were coming from research organizations, administration bodies and business, especially renewable energy production (wind, solar,wave and biomass)

 

Introduction

Workshop