Update of Pharmaceutical law in the EU -Focus on Generic Opportunities & Biosimilars

Speaker

Instructor: Elizabethann Wright
Product ID: 700195
Training Level: Basic

Location
  • Duration: 60 Min
Modifications in the EU law governing authorization of pharmaceutical products - The Cyprus clause, the new position of the innovative products and changes for the generic industry. The EU law governing authorization of pharmaceutical products has been substantially modified. The periods of market and data protection for innovative products have been clarified.
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$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$500.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

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The possibilities of generic authorization have been evolving and have now been joined by "biosimilars". These changes will have important impact on the pharmaceutical industry.

Areas Covered in the Seminar:

  • The purpose of the legislative review
  • The key changes in the modification
  • The new position of the innovative products
  • Changes for the generic industry
  • What are biosimilars
  • The Cyprus clause
  • Pharmacovigilance

Who Will Benefit:

  • In-house- legal counsels in the pharmaceutical firms
  • Consultants/Advisors to the pharmaceutical firms
  • The generic biosimilar industry
  • Regulatory affairs professionals in the pharmaceutical firms
  • Executive team in the pharmaceutical firms

Instructor Profile:

Elisabethann Wright, has been practicing European law for almost 20 years. This has included both periods in private practice and periods in international institutions. She focuses on European Union (EU) law relating to life sciences, with particular emphasis on pharmaceutical law, food law and the environment. She is also engaged in European public law and European court litigation.

Prior to joining Hogan & Hartson, Elisabethann served as senior legal officer and hearing officer at the EFTA Surveillance Authority.

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