ComplianceOnline

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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Read Frequently Asked Questions

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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