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Hot Topic ‘Choose Europe’ - How pharma & biotech can make the most of the EU Biotech Act and FAST-EU

Learn how these regulatory initiatives can be viable paths for increased competitiveness

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English

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Online 2,495 DKK ex VAT
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Frontpage > Courses > Hot Topic ‘Choose Europe’ - How pharma & biotech can make the most of the EU Biotech Act and FAST-EU

Summary


Join us for this Hot Topic Seminar (either in person or online) on the impact of these initiatives on your work within Clinical Trials, Pipeline, Regulatory Affairs and Market Access.

EU has released the draft for the upcoming Biotech Act which aims to ensure faster development of biotech health products to the benefit of patients whilst transforming the European Union into a global biotech powerhouse.

The FAST-EU (Facilitating and Accelerating Strategic Trials) has recently been launched and will serve as a pilot for the coming Biotech Act. Sponsors can apply for new trial initiations now.

Get a deep dive into the Biotech Act and the FAST-EU and the impact for pharma & biotech companies R&D cooperation and competitiveness

Sign up today. Limited physical seats.

Keywords

  • EU Biotech Act,
  • FAST-EU,
  • Competitiveness
  • Clinical trials

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Course leader & lecturers

  • Elisabeth Gammelgaard Ludvig
    Course leader
    Owner
    Sundhedsagenda
  • Christina Balslev Rindshøj
    Lecturer
    VP, Head of Regulatory Affairs
    Zealand Pharma A/S
  • Emil Bjerrum
    Lecturer
    Senioradvokat
    Bech-Bruun
  • Jakob Bjerg Larsen
    Lecturer
    Head of clinical trials and pharmaceutical manufacturing policy
    Lægemiddelindustriforeningen
  • Louise Bertelsen Forman
    Lecturer
    Partner, Attorney-at-law
    Bech-Bruun
  • Karen Ekkelund Petersen
    Lecturer
    PhD, DVM, Konstitueret Teamleder & Nonklinisk Assessor
    Lægemiddelstyrelsen
  • Frederik Grell Nørgaard
    Lecturer
    Head of Unit
    Lægemiddelstyrelsen
See all

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Is this course for you?

This course is for biotech and pharma professionals within:

  • Regulatory Affairs
  • Medical Affairs
  • Clinical Trials
  • Research & Development
  • Product Strategy
  • Market Access
  • Legal Affairs

What you will learn

  1. The major implications of the Biotech Act and FAST-EU
  2. How your company can benefit from the Biotech Act and the FAST-EU
  3. How you can plan & execute your work to make the most of the new initiatives already now
  4. How you can cooperate with authorities to speed up time-to-market

What your company will get


An employee who:

  1. Is up-to-date with latest regulatory guidelines impacting your organisation’s competitiveness
  2. Navigates the company’s work efficiently to meet the criteria in the EU Biotech Act and the FAST-EU initiative

Course information

Literature

Prior to the course you get access to mandatory and/or optional readings via your personal Atrium log-in.

Examination

There is no examination for this course.

Course leader

Elisabeth Gammelgaard Ludvig
Owner
Sundhedsagenda

Lecturers

Christina Balslev Rindshøj
VP, Head of Regulatory Affairs
Zealand Pharma A/S
Emil Bjerrum
Senioradvokat
Bech-Bruun
Jakob Bjerg Larsen
Head of clinical trials and pharmaceutical manufacturing policy
Lægemiddelindustriforeningen
Louise Bertelsen Forman
Partner, Attorney-at-law
Bech-Bruun
Karen Ekkelund Petersen
PhD, DVM, Konstitueret Teamleder & Nonklinisk Assessor
Lægemiddelstyrelsen
Frederik Grell Nørgaard
Head of Unit
Lægemiddelstyrelsen

Want to know more or need help?

Contact Client Manager, Laura Enemark Skyum at +45 40 46 58 98

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