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

Website https://www.compliance4all.com/control/w_product/~product_id=502136LIVE?channel=ourglocal_Oct_2018_S | Edit Freely

Category Manufacturing /Distribution, Clinical Research, Product Development

Deadline: October 21, 2018 | Date: October 22, 2018

Venue/Country: Online, U.S.A

Updated: 2018-08-07 14:26:38 (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.

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: supportcompliance4All.com