What's Changing for Life Science Product License Holders (BREXIT)

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.

Learning Objective:
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

Areas Covered in the Session:
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?

Who Will Benefit:
Executive & General Management
Legal
Regulatory Affairs
Quality Assurance
Manufacturing /Distribution
Clinical Research
Product Development
CROs
Consultants

Speaker Profile:
Robert J. Russell For the past 9 years, He has been President of RJR

Consulting, Inc. The company assists the pharmaceutical, medical device

and biotech industries in understanding and complying with International

Regulations affecting compliance, new product development,

manufacturing and quality assurance.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

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WHEN AND WHERE

22 October 2018
United States of America

ORGANIZER

Netzealous LLC DBA - Compliance4All

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Added 5 years ago by Compliance4All on Health