New EU Medical Device Regulation | Updated Regulation 2018

Start Date : May 17, 2018
End Date : May 18, 2018
Time : 9:00 am to6:00 pm

Phone : (800) 447-9407
Email : support@globalcompliancepanel.com

Location :
Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50

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:  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 


Contact us today!


NetZealous LLC DBA GlobalCompliancePanel


john.robinson@globalcompliancepanel.com  


support@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=901618SEMINAR?SEO


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Registration Info

Registration link :   http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901618SEMINAR?may-2018-seo-meetings4doc

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous LLC DBA GlobalCompliancePanel ,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

Tel: 800-447-9407
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com/


Event Categories: Business Practice and General Surgery.

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