Conferences
No conferences are currently scheduled. The information below is from the May 13 conference.
An Insider's View of the EU Medical Device Regulations
Wednesday, May 13, 2009
8:30 – 5:30
This all-day seminar by Dr. Michael Rinck of Promedt, a leading European Authorized Representative, will give you the latest insights on how to meet EU regulatory requirements throughout your product's life cycle. The seminar will include information on recent changes to the MDD and other supporting documents, preclinical testing, clinical studies in the EU Product Technical documentation, postmarket surveillance and the vigilance system.
AGENDA:
8:00 – 8:30 Registration and continental breakfast
8:30 – 8:45 Introduction
8:45 – 10:00 Update on European Regulatory changes and consequences for manufacturers
- MDD revision 2007/47
- CE marking process and Consequences for Manufacturers
- European National Registration requirements
10:00 – 10:15 BREAK
10:15 – 12:00 Technical File/Product Documentation – Part 1
- Safety and Preclinical Testing Strategies
- Biocompatibility Evaluation and E/L Testing/Evaluation
- Process Validation – Sterilization aspects
- Risk Management Strategies
12:00 – 12:30 Questions and Answers
12:30 – 1:30 LUNCH
1:30 – 3:00 Technical File/Product Documentation – Part 2
- Clinical Evaluation/Clinical Data
- Post Market Surveillance Strategies
- Vigilance Aspects
3:00 – 3:15 BREAK
3:15 - 4:00 Combination products, European perspective
4:15 – 5:00 Vigilance Systems and Authorized Representative
5:00 – 5:30 Final closing and discussion
SPEAKER BIO:
Michael Rinck is the founder and managing director of MT Promedt Consulting, a German consulting company specializing in Regulatory Strategies, Quality Management Systems, CE marking, European Authorized Representative services and international product registrations for medical devices, IVD products and pharmaceuticals. He is a pharmacist and microbiologist with a Ph.D. in microbiology from the Technical University in Berlin/Germany.
With more than 25 years experiences in food technology and medical product development, manufacturing, quality assurance, and regulatory affairs, he encompasses a broad spectrum of medical devices, API and pharmaceutical products. He has specific expertise on sterilization technologies for medical devices and pharmaceuticals. He was responsible in several positions for R&D, Quality Control, Manufacturing, and QA / RA for a major health care company for more than 10 years.
He is currently acting as “Safety Officer” according to German MDA, Head of QA/RA for Medical Device Manufacturers; Director QA/RA for API manufacturers and as a Qualified Person (QP) for medicinal products.
LOCATION:
Doubletree Hotel Denver North
8773 Yates Drive
Westminster, CO 80031
Phone: 303-427-4000
REGISTRATION:
$100.00 Industry Representative
$ 35.00 Government or student
To register, please go to www.regonline.com/rmras
For questions or additional information, contact Nan Matthews, 303-843-6414, rmras@themattgrp.com