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

Instructor: Elizabethann Wright
Product ID: 700195
Training Level: Basic
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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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.

Description

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.

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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