Going Global: Best Practices for Integrating Business Development and Regulatory Compliance (life science focus)

Why Should You Attend:

Many companies across Consumer Products, Food, Cosmetic and Life Science offerings are expanding sales by taking their products global. It is much more cost effective in expanding on registrations and licenses already in place in one part of the World, than in developing new products for a specific region. Being ready in knowing what to expect, what resources must be in-place, what supportive data will be required and how language and cultural norms factor into your country success rate can be underestimated or simply overlooked.

This 90 minute live, interactive webinar will present considerations and regional differences for the U.S., Canada, the EU, Latin America and many countries in the Asia / Pacific rim. We will discuss what you will encounter as a regulated and / or registered product as we march around the globe. Leaving this seminar, you should walk away with a sequencing of considerations, that must be nailed down, to consider the expansion to that region a success. Realistic timing of events will be discussed in order to accurately set internal timeline expectations. At the conclusion of this roughly 75 minute presentation, we will open the telephone lines for specific Q&A with the speaker. Companies previously attending this discussion have said it opened up their minds to thinking very differently as they globally expanded.

Areas Covered in the Webinar:

• The "Going Global Opportunity".
• Breadth of Products Being Discussed.
• Key Considerations; Big Picture.
• Country Establishment & Resources.
• Regional & Country Specific Regulations.
• Product Claims & Literature.
• Labeling Requirements.
• Manufacturing Authorizations / GMP.
• Importing / Exporting.
• Key Regional Issues for:
  • U.S.
  • Canada
  • Europe
  • Latin America
  • Asia / Pacific
• Q&A.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies, with products requiring notification or registration within a country before importation will be allowed. The employees who will benefit include:

• Executive management responsible for growth and regional expansion
• Business development
• Regulatory compliance specialists
• Global supply chain
• Quality assurance personnel
• Sales / marketing personnel
• Customer service

Robert J Russell
President, RJR Consulting, Inc

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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