New EU Medical Device Regulation | Updated Regulation 2018

Start Date : June 27, 2018
End Date : June 28, 2018
Time : 9:00 am to6:00 pm

Phone : 800-447-9407
Email : globalcompliancepanel@gmail.com

Location :
Hilton Garden Inn O'Hare 2930 S. River Road Des Plaines, IL 60018

Website

Description

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:  Chicago, IL Date: June 27th & 28th, 2018 and Time: 9:00 AM to 6:00 PM


Venue:  WILL BE ANNOUNCED SOON


Price:


Price: $1,495.00 (Seminar Fee for One Delegate)


Register for 5 attendees Price: $4,485.00 $7,475.00 You Save: $2,990.00 (40%)*


Register for 10 attendees Price: $8,222.00 $14,950.00 You Save: $6,728.00 (45%)*


Sponsorship Program benefits for “New EU Medical Device Regulation | Updated Regulation 2018” seminar


For More Information- https://www.globalcompliancepanel.com/control/sponsorship 


Contact us today!


NetZealous LLC DBA GlobalCompliancePanel


john.robinson@globalcompliancepanel.com  


Toll free: +1-800-447-9407


Phone: +1-510-584-9661


 Website: http://www.globalcompliancepanel.com


 


Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901615SEMINAR?SEO


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Registration Info

https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901615SEMINAR?meetings4docs_june_2018_seo

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous LLC DBA GlobalCompliancePanel ,
161 Mission Falls Lane,suite 216

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.

Tel: 8004479407
Mobile: 8004479407
Email: globalcompliancepanel@gmail.com
Website: https://www.globalcompliancepanel.com


Event Categories: Health & Nutrition and Physical Medicine.




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