Going Global: International Export

and EU Clinical Regulatory Considerations

PorterWright
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RJR-Consulting

Join BioOhio, Porter Wright, and RJR Consulting for a program designed for international trade attorneys, regulatory professionals and business executives interested in understanding the basics of exporting to the European Union (EU) and regulatory environment of medical devices and pharmaceuticals in the EU.

In today’s global marketplace, an understanding of international trade, foreign laws, regulatory environment, and international standards is a must.  Global marketers must deal not only with the legal elements of  traditional trade issues such as customs duties, but also with an array of complex laws that can affect market access around the world.  For example, product standards, conducting clinical trials, international clinical trials data, package labeling requirements, environmental protection mandates, privacy laws and other international, regional or national regulations can effectively restrict a company’s ability to conduct business in international markets.  Put another way, the need for companies to acquire and update staff skills is becoming more and more important as increasing global competition means that businesses need to compete more effectively in order to survive.

Date, Time & Location

November 29, 2017

1:00 to 5:00 PM

Porter Wright, Huntington Center

41 South High Street, Suite 2900

Columbus, OH 43215

Cost

BioOhio Members (1-10 employees) – $95

BioOhio Members (11+ employees) – $119

Non Members – $219

Government – $95

Agenda

1:00 PM – 1:20 Registration & Networking

1:20 – 1:30 Welcome & Opening Remarks

John F. Lewis, Jr., President & CEO, BioOhio

  • Highlight the current statistics of Ohio’s growing bioscience industry

1:30 – 2:15 Overview of EU legal issues for new exporters

Dixon Miller, Attorney, Porter Wright

  • International contracting/commercial transactions/E Commerce
  • Funds transfers from foreign countries
  • U.S. Export controls
  • Foreign country customs and import controls
  • Multiple country taxation issues
  • Dispute resolution issues

2:15 – 3:00 Potential Strategies

Dixon Miller, Attorney, Porter Wright

  • Use of Sales Representatives
    • Advantages/disadvantages of using sales representatives
    • Laws governing sales representatives in different jurisdictions
  • Joint marketing agreements
  • Deciding when to form a foreign subsidiary

3:00 – 3:15 Networking Break

3:15 – 4:00 Going Global – International Regulatory and Business Considerations & Opportunities

Robert J. Russell, President, RJR Consulting

Medical device and pharmaceutical companies of all sizes are attempting to increase revenues by taking their products to other global markets. For the unprepared, this daunting task is usually met with pitfalls, roadblocks and significant regulatory challenges.  Knowing when and how to legally enter a new global market is a key driver to a successful business expansion.

This presentation will provide general insight to regulatory compliance considerations and regional differences when entering new global markets. We will discuss key elements to consider before, during and after the registration and marketing of pharmaceuticals, devices and biologics in the U.S., the EU, Latin America, Asia Pacific and the Middle East.

  • Introduction to global life science markets
  • Country establishment requirements
  • Product classification
  • Clinical data considerations
  • Manufacturing / Quality considerations
  • Product licensing requirements
  • Labeling requirements
  • Product claims and marketing
  • Import / Export considerations
  • Key regional challenges
    • US, EU, LatAm, Asia Pacific, Middle East
  • Working with Global Authorities

4:00 – 4:45 EU Regulatory Compliance for Life Science Products

Jim Russell, Director of Business Development and Regulatory Affairs, RJR Consulting

This session covers the regulatory process necessary to be able to market bioscience products (Pharmaceuticals, Biologics and Medical Devices) in the EU. The presentation will detail the regulatory structure and authorities that exist in the EU along with the pathways and procedures available to obtain the necessary pre-market approvals for each type of product in the EU.

  • EU Agency Regulatory Structure
  • Applicable Regulations
  • Country Establishment requirements
  • Product classification
  • Clinical Studies & the Clinical Trial Regulation
  • GMP & Quality Systems requirements
  • Registration/Marketing Authorization Procedures/CE marking
  • Changes to Marketed Products – Variations / Amendments / Renewals
  • Post-Market Vigilance requirements
  • Compare/Contrast of EU and FDA procedures
  • Impact of Brexit

4:45 Closing Remarks, Networking