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

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Category Online Professional Trainings;world class professionals trainings;professionals training courses

Deadline: February 03, 2019 | Date: February 04, 2019

Venue/Country: Online, U.S.A

Updated: 2019-01-09 16:10:22 (GMT+9)

Call For Papers - CFP

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