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BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now

Event Details

BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now

Time: February 4, 2019 from 10am to 11:30am
Location: Online
Street: Online
City/Town: Fremont
Website or Map: https://www.traininng.com/web…
Phone: (510) 962-8903
Event Type: webinar
Organized By: Traininngdotcom-LLC
Latest Activity: Jan 10

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Event Description

Overview

The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward.

The UK, by definition would become a "third country". Preparing for the withdrawal doesn't just involve the Healthcare Authorities, but every manufacturer and /or license holder of a pharmaceutical, biologic, medical device or combination product in the UK and EU.

Marketing Authorization holders of centrally authorized or mutually authorized [MRP /DCP] product licenses for pharmaceuticals and biologics along with CE-marked medical devices for human or veterinary use will have legal repercussions when the UK exits the EU. While there is still considerable uncertainty in a withdrawal agreement, there is now enough known about the likely implications that manufacturers and license holders need to start making plans NOW, so they don't find themselves in Non-Compliance with the new legal framework.

Learning Objectives

  • Upon completion of this course, attendees will be able to accurately determine how Brexit will affect their operations and existing licensed Life Science Products in the UK and EU
  • It will allow companies to make plans on becoming compliant on "What is Known" and to remain agile as the rest of the implications become clearer

Course Agenda

  • EU Regulatory and Legislative Structure [with and without the UK]
  • Issued Laws: Directives vs. Regulations
  • Impact on Filing Registrations with EMA in Q1 2019
  • Brexit Impact on License Holders Established in the UK
  • What if my EU Authorized Representative is Located in the UK?
  • What if the QPPV Resides in the UK?
  • What if API Manufacturing is Located in the UK?
  • What if Finished Product Manufacturing is Located in the UK?
  • What if Batch Release is Done in the UK?
  • What's the Effect on Generic or Hybrid Licenses Against a Reference Product Authorized in the UK?
  • What's the Effect on More Specialized Products Like Herbal Medicines or Orphan Drugs?
  • How Will the UK's Withdrawal Effect the Sunset Clause?
  • What's the Effect Difference on Nationa or Mutual Recognition [MRP /DCP] Licenses vs. Centrally-Licensed Products?
  • How is Brexit anticipated to Effect CE Certification or ISO-13485 Certification on Medical Devices?
  • Wrap-Up and Q&A

Who Will Benefit

This workshop will be of great value to companies manufacturing in the UK /EU or holding Marketing Authorizations in the UK /EU. It is primarily designed to benefit personnel within the following disciplines:

  • Executive & General Management
  • Legal
  • Regulatory Affairs
  • Quality Assurance
  • Manufacturing /Distribution
  • Clinical Research
  • Product Development
  • CROs
  • Consultants

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