Why Should You Attend:
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.
Attend this webinar to understand how to accurately determine how Brexit will affect the 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.
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.
Detailed Agenda of the Session:
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:
For the past 9 years, Robert J. Russell 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. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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