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Course "The New EU Medical Device regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
Regulation proposals of the European Commission Background
In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject. The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
This Seminar will look at what to expect when the new regulation is implemented. Including: the transition period, Effect on Notified Bodies, Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.
Why you should attend:
Because the current Directive will be significantly altered and replaced by a Regulation which is legally binding on all Member States.
Areas Covered in the Session:
Who will benefit:
Agenda:
Day 1 Schedule
Lecture 1 (90 Mins):
The new MDR main changes
Lecture 2 (90 Mins):
Notified Bodies under the New MDR
Lecture 3 (90 Mins):
Impact of the MDR on Quality Management Systems (QMS)
Lecture 4 (90 Mins):
Technical Documentation
CASE STUDY 1 - Including a walkthrough of expected outcomes for all case study exercises
Wrap up of day 1 & Q&A's
Day 2 Schedule
Lecture 1 (90 Mins):
Clinical aspects and testing
Lecture 2 (90 Mins):
Periodic Safety Update reports
Lecture 3 (30 Mins):
Common Specification (CS)
Common Tech Specifications
Lecture 4 (90 Mins):
Combination Products
CASE STUDY 2 - Including a walkthrough of expected outcomes for all case study exercises
Wrap up of day 2 & Q&A's
Speaker
Salma Michor
PhD, MSc, MBA, CMgr, RAC
Salma Michor is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King's College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.
Location: Zurich, Switzerland Date: May 17th & 18th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland
Price:
Price: $1,695.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*
Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)*
Register now and save $200. (Early Bird)
Until April 10, Early Bird Price: $1,695.00 From April 11 to May 17, Regular Price: $1,895.00
Sponsorship Program benefits for “New EU Medical Device Regulation | Updated Regulation 2018” seminar
For More Information- https://www.globalcompliancepanel.com/control/sponsorship
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