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

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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Feb-2007

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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.


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.

Follow us :
Latin America: Regulatory Compliance Requirements for Life Science Products
The Veterinary Drug Approval Process and FDA Regulatory Oversight

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.

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