קטגוריה: אביזרים ומכשור רפואי (אמ"ר) Medical Devices
Post-Marketing Strategies for Medical Devices – How to keep your device on the market
מרצה: גב' שושנה פרידמן
תאריך: 18 בדצמבר 2007
מיקום הקורס:  מלון מטרופוליטן, רח' טרומפלדור 11, תל אביב
שפת הקורס: עברית
משך הפעילות: יום לימודים מלא
שעות: 8:30-17:00
עלות: 1,750 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 07124
Post-Marketing Strategies for Medical Devices – How to keep your device on the market
 

 

 


1-Day Course with
Shoshana Friedman
December 18, 2007

 
The course provides an overview of the post-marketing regulation of medical devices in the US and focuses on developing post-marketing strategies to ensure regulatory compliance and maintain marketing authorizations.

   Benefits to the Participants

  • Expanding regulatory perspective throughout the post-marketing portion of the product lifecycle
  • Learn strategies and tactics needed to ensure regulatory compliance and maintain marketing authorizations
  • Receive  basic tools for evaluating alternative approaches to post-marketing issues
  • Study examples of  how to cope with regulatory dilemmas in the post marketing domain

   Issues to be covered

• Advertisement and Promotion
• Off-Label Use
• QSR Inspection and FDA 483
• Warning Letters
• Recalls
• MDR and MAUDE

   Who should attend

  • Senior-level regulatory affairs professionals
  • Quality Managers 
  • Managers responsible for introducing and maintaining medical devices in the US market (e.g., marketing, sales, clinical, etc.) may also benefit from this course.  

   About the Speaker
Shoshana (Shosh) Friedman
is the President and CEO of Push-Med Ltd. and a Senior Partner at BioVance Medical LLC. She has more than 15 years of experience in the fields of regulatory affairs, clinical trials, and quality assurance of medical devices and biotechnology. She is a highly respected expert and speaker in international forums and is considered a pioneer in the regulatory affairs community. In recognition of her achievements in the field, she was awarded in 2005 the Richard E. Greco Award by the Regulatory Affairs Professionals Society (RAPS), the highest honor bestowed by RAPS upon outstanding leaders who have made significant contributions in the field. Mrs. Friedman holds a B.Sc. in mathematics and physics from Haifa University, a Business Administration Certificate (with Honors) from Hebrew University, a QA Lead Assessor certification from Bywater, and a Regulatory Affairs Certification (RAC) from RAPS.


Category: Medical Devices
Duration: 1-Day Course
Hours: 8:30-17:00
Location: Lev Hakongressim, Weizmann Science Park, Ness Ziona
Price: 1,750 NIS + VAT
SKU: 07124


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