Thursday February 23, 2012 Thursday February 23, 2012
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| Series 3: Examine the Centralized Procedure Date: Thursday, March 8, 2012 Time: 1:00 PM ET | 10:00 AM PT Presenter: Ms. Peggy J. Berry, MBA, RAC |
| Series 4: Introduction to EU Medical devices Regulations Date: Tuesday, April 3, 2012 Time: 1:00 PM ET | 10:00 AM PT |
Registration opening soon! |
| Series 5: Medical device clinical evaluations and investigations Date: Wednesday, April 25, 2012 Time: 1:00 PM ET | 10:00 AM PT |
Registration opening soon! |
| Series 6: Vigilance and PMS Date: Friday, May 11, 2012 Time: 1:00 PM ET | 10:00 AM PT |
Registration opening soon! |
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Time: 1:00 PM ET | 10:00 AM PT | Duration: 2 hours with Q&A |
Areas Covered in the Session:
Examine the Centralized Procedure
Case Study Review
How to file Applications for the Marketing Authorizations in the European Union
Centralized CTD Submission and Approval Procedures
Preparing a Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL)
Areas Covered in the Session:
Introduction to EU Medical devices Regulations
Medical device classification (EU)
Medical devices – Conformity assessment & CE marking EU submissions
Registration opening soon!Areas Covered in the Session:
Medical device clinical evaluations and investigations
Case Study Review
Quality Systems (ISO 13485)
Risk Management (ISO 14971)
Registration opening soon!Areas Covered in the Session:
Vigilance and PMS
Technical documentation
Case Study Review
Registration opening soon!This webinar series is designed for Directors, managers and associates in the Pharmaceutical and Biotechnology, and allied industries with daily responsibilities in the following areas:
Peggy J. Berry, MBA, RAC, Vice President, Head of Quality & Regulatory Affairs at Amarin where she is responsible for the strategic management and oversight of the regulatory affairs, quality, & pharmacovigilance departments. She has more than 20 years of experience in drug development and regulatory affairs including senior level positions with Dyax Corp, AstraZeneca, and Dey Pharmaceuticals and roles at two clinical contract research organizations (ILEX Oncology and Cato Research Ltd.) as well as project management work in review divisions at the FDA. She has a BS in Biology and an MBA.
Dr. Salma Michor is founder and CEO of Michor Consulting e.U, serving such clients as Johnson & Johnson, Novartis, Valeant Pharma and Colgate Palmolive among others. Previously, Michor worked in regulatory and quality assurance with Chiesi-Torrex and Wyeth Whitehall export, and as director of supporting operations at 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. Michor served on the RAPS Board of Editors, 2005–10, is a member of the RAPS European Advisory Committee and is a member of the Board of Directors. 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 EU RAC.
Single Attendee: CAD $195.00
Group of 5 or less per location: CAD $400.00
Group of 6 to 10 attendees per location: CAD $750.00
Group of 11 to 20 attendees per location: CAD $1250.00
Single attendee refers to single participant at a single computer/login.
Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.
Please contact us at webinar@ipacanada.com for multiple-location group rates or any other enquiries.