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Parallel Scientific Advice: How effective is the system established between the EMEA and the FDA

Instructor: Elisabethann Wright
Product ID: 700262
Training Level: Advanced
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
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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This Pharmaceutical training examines the system its benefits and its drawbacks and how effective is the system established between the EMEA and the FDA.

Description

The authorization of medical products by the FDA is not recognized in the EU. Neither is authorization by the EMEA Recognized by the FDA.

In an attempt to resolve this lack of mutual Recognition, the EU and the US have established a system of parallel scientific advice. This Webinar examines the system its benefits and its drawbacks.

Areas Covered in the seminar:

  • The background to establishment of the system of parallel scientific Advice
  • The practical application of the system
  • Examples of the system in practice

Who Will Benefit:

  • pharmaceutical companies
  • Pharmaceutical innovative companies, whose market covers both the US and the member states of the EU
  • Scientists
  • Buyers
  • Regulatory affairs specialist

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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