NetZealous LLC DBA GlobalCompliancePanel, Chicago, IL
2018-06-27
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: 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 Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/ Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/ Follow us on Twitter: https://twitter.com/GCPanel
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