Online Course: Exclusivities, Extensions, and Exemptions in The Pharmaceutical Industry

Forum Institut für Management GmbH

Seminar

Online

Preis auf Anfrage

Die besten Kurse zum Thema Pharmazie

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Beschreibung

  • Kursart

    Seminar

  • Methodik

    Online

This online practical training course teaches IP professionals in the pharmaceutical industry what they need to know about regulatory affairs.

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Meinungen

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2020

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Themen

  • Basic
  • Extension
  • Marketing

Inhalte

Detailed programme Intensive Course: Each day from 13:00-17:15 CET
Pre-Meeting on 28 June 2021 from 14:00 to 15:00 CET Regulatory exclusivities
  • Types of procedures to obtain a marketing authorization in the European Union
  • Data and market exclusivity
  • Protection periods
  • Orphan drugs
    • Patent term extensions
  • Supplemental Protection Certificates (SPCs) in the EU
  • Patent Term Extensions (PTEs) in the US
  • Pediatric Extensions
  • Patent linkage (the US-FDA Orange Book)
    • Exemptions from IP protection
  • Research exemptions
  • Bolar exemptions
  • The SPC manufacturing waiver
    • Case study: Assembling the principal exclusivities, extensions and exemptions for a drug
  • How and where to obtain the relevant data for the EU
  • Determination of the relevant data for the US
  • Preparation of a chart/overview

    • Detailed programme Intensive Course: Each day from 13:00-17:15 CET
    Pre-Meeting on 28 June 2021 from 14:00 to 15:00 CET     Regulatory exclusivities
  • Types of procedures to obtain a marketing authorization in the European Union
  • Data and market exclusivity
  • Protection periods
  • Orphan drugs
    • Patent term extensions
  • Supplemental Protection Certificates (SPCs) in the EU
  • Patent Term Extensions (PTEs) in the US
  • Pediatric Extensions
  • Patent linkage (the US-FDA Orange Book)
    • Exemptions from IP protection
  • Research exemptions
  • Bolar exemptions
  • The SPC manufacturing waiver
    • Case study: Assembling the principal exclusivities, extensions and exemptions for a drug
  • How and where to obtain the relevant data for the EU
  • Determination of the relevant data for the US
  • Preparation of a chart/overview

    • Detailed programme
    Detailed programme
    Intensive Course: Each day from 13:00-17:15 CET
    Pre-Meeting on 28 June 2021 from 14:00 to 15:00 CET
    Intensive Course: Each day from 13:00-17:15 CET
    Pre-Meeting on 28 June 2021 from 14:00 to 15:00 CET Regulatory exclusivities
  • Types of procedures to obtain a marketing authorization in the European Union
  • Data and market exclusivity
  • Protection periods
  • Orphan drugs
    • Patent term extensions
  • Supplemental Protection Certificates (SPCs) in the EU
  • Patent Term Extensions (PTEs) in the US
  • Pediatric Extensions
  • Patent linkage (the US-FDA Orange Book)
    • Exemptions from IP protection
  • Research exemptions
  • Bolar exemptions
  • The SPC manufacturing waiver
    • Case study: Assembling the principal exclusivities, extensions and exemptions for a drug
  • How and where to obtain the relevant data for the EU
  • Determination of the relevant data for the US
  • Preparation of a chart/overview

    • Regulatory exclusivities
  • Types of procedures to obtain a marketing authorization in the European Union
  • Data and market exclusivity
  • Protection periods
  • Orphan drugs
    • Patent term extensions
  • Supplemental Protection Certificates (SPCs) in the EU
  • Patent Term Extensions (PTEs) in the US
  • Pediatric Extensions
  • Patent linkage (the US-FDA Orange Book)
    • Exemptions from IP protection
  • Research exemptions
  • Bolar exemptions
  • The SPC manufacturing waiver
    • Case study: Assembling the principal exclusivities, extensions and exemptions for a drug
  • How and where to obtain the relevant data for the EU
  • Determination of the relevant data for the US
  • Preparation of a chart/overview

    • Regulatory exclusivities
  • Types of procedures to obtain a marketing authorization in the European Union
  • Data and market exclusivity
  • Protection periods
  • Orphan drugs

    • Verwandte Kategorien

    Online Course: Exclusivities, Extensions, and Exemptions in The Pharmaceutical Industry

    Preis auf Anfrage

    Die besten Kurse zum Thema Pharmazie

    Alle anzeigen

    Alle anzeigen