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Evènement :New EU Medical Device Regulation | Updated Regulation 2018
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Dates :Jeudi 17 Mai 2018 - Vendredi 18 Mai 2018

Lieu :Hilton Zurich Airport Hohenbuhlstrasse 10
8152 Opfikon-Glattbrugg
Switzerland, États-Unis

Type :Formation - Audience Internationale

Accréditation :--


 

Informations

 

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:

  • The updated Regulation
  • Implementation dates and transition
  • Main changes and products affected
  • Effect on medical device manufacturers

Who will benefit:

  • Clinical Trial Managers
  • Regulatory Affairs
  • Medical Officers

Agenda:

 

Day 1 Schedule


Lecture 1 (90 Mins):

The new MDR main changes

  • Main updates
  • Transition periods
  • Effect on medical device manufacturers
  • Regulatory landscape

Lecture 2 (90 Mins):

Notified Bodies under the New MDR

  • Effect on NBs
  • When will NBs begin conformity assessment against the new Regulation?
  • Main effect on medical device manufacturers

Lecture 3 (90 Mins):

Impact of the MDR on Quality Management Systems (QMS)

  • When do I need to update my QMS?
  • What main points need to be considered?
  • Effect on medical device manufacturers

Lecture 4 (90 Mins):

Technical Documentation

  • Class I and IIa devices
  • Effect on class IIb devices
  • Class III devices

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

  • Class I and IIa devices
  • Effect on class IIb devices
  • Class III devices

Lecture 2 (90 Mins):

Periodic Safety Update reports

  • Content of PSUR
  • Frequency

Lecture 3 (30 Mins):

Common Specification (CS)

Common Tech Specifications


Lecture 4 (90 Mins):

Combination Products

  • Definitions
  • Requirements
  • Technical documentation

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 “The New EU Medical Device regulation” 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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Lieu

Plan et itinéraire
Adresse de la formation :
Hilton Zurich Airport Hohenbuhlstrasse 10
8152 Opfikon-Glattbrugg
Switzerland
États-Unis
Tél : 8004479407
Plan et itinéraire

Renseignements

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Précisions

New EU Medical Device Regulation | Updated Regulation 2018 Médecine - Pharmacie
new eu medical device regulation, quality management systems (qms), technical documentation, clinical trial requirements, udi and combination products, mdr on quality management systems, effect on medical device manufacturers
Professionnels, Clinical Trial Managers Regulatory Affairs Medical Officers
1 1 --
English

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