Boston Professional Events List


2 Day Workshop Product Registration and Navigating the Approval Process with Regulatory Authorities in Asia Pacific, Europe, Middle East and The Americas


Date
Apr 25, 2018 - 08:00 AM - Apr 26, 05:00 PM
Organizer
conference Manager
Location
Hilton Garden Inn Boston Logan Airport, Address: 100 Boardman St, Boston, MA 02128, USA

Boston,
Massachusetts,
US,
ZIP: 02128
Phone: +1 617-567-6789

Ticket Price: Seminar One Registration -$ 1395 Special Group Discount Register for Four attendees -$ 3885
Description

One of the first steps towards selling a Class II medical device or IVD in the United States is to file a Premarket Notification with the FDA, also known as an FDA 510(k) submission. Technically, the FDA does not "approve" medical devices or IVDs for sale under the 510(k) process; the agency gives "clearance" for them to be sold in the U.S. We use the term "FDA approval" for simplicity. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.


Areas Covered

•    Get assistance with medical device registration and medical device approval
•    Learn how to access new markets and obtain medical device approval in all the countries listed
•    Complete your registration in order to obtain medical device approval as efficiently as possible while realizing that some markets/countries will be more challenging
•    Navigate the regulatory system, achieve product registration, and access the medical market
•    In a group setting, review and discuss pain points, challenges and workable regulatory and compliance solutions 



Who will Benefit

This seminar will provide an overview and in-depth snapshot of the product registration and approval process for Asia Pacific, Europe, Middle East, United States, Canada, Mexico and South America. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the registration and approval process in select countries, including:
         •        Regulatory Affairs Management
         •        Regulatory Affairs Specialist
         •        Auditors
         •        Compliance Officer
         •        Compliance Specialist
         •        Clinical Affairs
         •        Quality Assurance Management


Learning Objectives

David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVD's, and bio/pharmaceutical manufacturers on the global landscape.
 


Speaker Details


Know Your Speaker

David R Dills  Regulatory Affairs & Compliance Consultant
David R. Dills,Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems.

Event Categories
Keywords: pharmaceutical , biotechnolog




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