WorkshopNeuroRescue

Market Access for Medical Devices

Tuesday, June 25, 2013, 13:00 to 17:30
Bürgerhaus, Garching / Munich
Registration: Please register via faxreply

Participation Fee: 180 €, members of the Forum MedTech Pharma e.V.: 90 € plus VAT incl. congress documentation and catering

At concomitant participation at the Partnering for MedTech & Pharma the fee is reduced: 120 €, members of the Forum MedTech Pharma e.V.: 60 €

Concept and Organisation: Forum MedTech Pharma e.V. and Bayern Innovativ GmbH

Contact Person: Dr. Ilja Hagen (hagen@medtech-pharma.de)

Cancellations received before June 19, 2013 are exempt from charges. For later cancellations and for not-attendance, the full amount will be incurred.

Topic

Medical devices play an essential role in healthcare. Especially, the ability for innovation of the business sector contribute significantly to enhance the quality and efficacy of healthcare. The current revisions of the medical device directives may affect innovation and competitiveness of this sector as well as market access within the European Economic Area in general.
The efficient realisation of innovations requires, more than ever before, networking throughout professional disciplines and collaboration with appropriate partners.
Accompanying the International Partnering Event for MedTech & Pharma the Workshop will give an overview on European regulation for certification and conformity assessment procedures. It will focus in particular on outsourcing and supplier manufacturer relations.




Time Speaker Title
13:00 Dr. Ilja Hagen
Forum MedTech Pharma e.V., Nuremberg
Welcome

(Download for members and participants only, PDF 3.9 MB)

13:15 Dr. Roman Rittweger
Advisors in Healthcare, Munich
Market Access for Medical Devices - Introduction

(Download for members and participants only, PDF 1.8 MB)

Regulatory Framework

13:45 Dieter Eckert
TÜV SÜD Product Service GmbH, Munich
CE Marking and Responsibilities of Manufacturers

(Download for members and participants only, PDF 1.0 MB)

14:10 Dr. Christian Schübel
i.DRAS GmbH, Martinsried
Changes in EU-Regulation

(Download for members and participants only, PDF 0.2 MB)

14:35 Dr. Karin Lübbers
Yes Medical Device Services GmbH, Friedrichsdorf
International Approval Strategies

(Download for members and participants only, PDF 4.2 MB)

15:00 - 15:30    Coffee Break

Outsourcing and Supplier

15:30 Dr. Karsten Sassenscheid
Seleon GmbH, Heilbronn
From Product Development to Licensing

(Download for members and participants only, PDF 6.0 MB)

15:55 Arjan Stok
STOQ Managementservice, Birkenfeld
Supplier Manufacturer Relations

(Download for members and participants only, PDF 8.3 MB)

16:20 Dr. Karsten Hiltawsky
Drägerwerk AG & Co. KGaA, Lübeck
Quality Assurance and Supplier Certification

(Download for members and participants only, PDF 2.5 MB)

16:45 Dr. Christian Fulda
Jones Day, Munich
Product Liability for Medical Devices

(Download for members and participants only, PDF 0.5 MB)

   17:10      Discussion

17:45 Evening Reception


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