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AICC Medical Committee Member Alan Minsk (AGG) featured in Israel Program

Critical Regulatory Updates
5 November 2013
8:45 am–17:30 pm
haKfar haYarok
Ramat HaSharon, Israel

To Register: click here

Join your regulatory colleagues from across Israel for a day of networking and to hear expert presentations on critical regulatory updates. This event is sponsored by the RAPS Israel Chapter and is intended to advance knowledge and facilitate networking among local regulatory professionals.

This program will review the current state of regulations for medical device reporting in the US, Israel and the EU, including legal and regulatory requirements, recently published guidance documents and emerging trends. Scheduled presentations will cover best practices for combining regulatory and reimbursement strategies; the e-beam sterilization validation method, advantages and disadvantages, as well as regulatory requirements for this process. Presenters will elaborate on critical updates for software validation and patients privacy trends (including mobile and wireless technologies).

Scheduled presentations include:

Critical Updates for Medical Device Reporting
Alan Minsk, Arnall Golden Gregory, LLP

  • What is and what constitutes an MDR?
  • What questions should be asked in investigation and evaluation?
  • If not an MDR, what are the other regulatory considerations?

When Regulatory Meets Reimbursement: Combining Regulatory and Reimbursement Strategy
Amir Inbar, Mediclever Reimbursement Consultants

  • A review of regulatory and reimbursement strategy.
  • When to start the reimbursement process.
  • Where to begin with regulatory and reimbursement interaction.

Beam Sterilization
Shuki Weisntein, Sor-Van Radiation LTD

  • E-Beam Technology.
  • Sterilization and Aseptic Processing.
  • Advantages of E-Beam Sterilization.
  • Advances in E-Beam Sterilization Features.
  • Containment Challenges, both current and future applications.

Critical Updates in Software Validation and HIPAA
Liran Eisenberg, Amber IT Consulting

  • New guidances and standards.
  • Medical device privacy protections in the US and EU.
  • Updates on software validation.
  • Recommendations for minimizing risk.

A continental breakfast and lunch buffet will be available for all meeting participants, and each attendee will receive a certificate of attendance.

Date/Time: Tuesday, 5 November 2013
8:45–9:00 am – Registration and Networking
9:00–9:15 am – Greeting and Foreword
9:15 am–12:30 pm – AM Sessions
12:30–13:15 pm – Lunch
13:15–17:30 pm – PM Sessions
Location:   Krypton
haKfar haYarok
Ramat HaSharon, Israel

View the facility map and directions or call +972 528 529 813


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