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.
- 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
- 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
- Regulatory Affairs
- Quality Assurance
- Manufacturing /Distribution
- Clinical Research
- Product Development
Robert J. Russell is a Global Regulatory and CMC expert with 28 years of prior industry experience in international regulatory management and compliance, global business development and global supply chain management. Mr. Russell formerly held senior leadership positions, in these functional areas, at Dow Pharmaceuticals and Cordis-Dow Medical Devices.
His experience and knowledge span Healthcare Authority's requirements and regulatory processes across Life Science products.
For the past 18 years, Bob has been President & CEO of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding Regulations affecting compliance and in conducting product registrations with their clients in more than 95 countries.
He holds a BS / MS in Chemistry.