Pathways to faster medicine approval

Get an overview of established and new pathways in the EU, UK and US

5. Nov 2021

1 day course

English

5,800 DKK ex VAT
(app. 780 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

The demand for shorter regulatory review timelines during COVID-19 has proven that it is crucial for the life science industry to look into alternative regulatory pathways.

Get an overview of the EU, UK and US approach at this course where experts from authorities and the industry share their experiences and perspectives. Also, we will discuss the criteria that apply including what kind of medical need would justify the different options.
 

Key words

  • Alternative regulatory approvals
  • Approval timelines
  • Rolling review
  • Medical need
  • Shorter review timelines
  • Emergency use
  • Accelerated review

Hi! Do you need help choosing the right course?

We are ready to help you at +45 39 27 60 60 or contact@atriumcph.com

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Course leader(s) & Lecturers

  • Inger Mollerup
    Course leader
    Independent Regulatory Consultant
    Inger Mollerup Regulatory Consulting
  • Jens Heisterberg
    Lecturer
    VP, Regulatory Policy and Intelligence
    Novo Nordisk A/S
  • Lucia D'Apote
    Lecturer
    EUCOPE R&D Topic Lead, Scientific advice, PRIME, RWE/Big data
    Amgen Ltd., UK
  • Robert Babilon
    Lecturer
    President
    Prosoft Clinical
  • Christian Schneider
    Lecturer
    Head of Biopharma Excellence and Chief Medical Officer (Biopharma)
    PharmaLex Denmark A/S
  • Ida Sofie Jensen
    Lecturer
    CEO of The Danish Association of the Pharmaceutical Industry
    Lif
See all

IS THIS COURSE FOR YOU?

This course is for project and regulatory leaders as well as pharmaceutical specialists with an advanced level of regulatory experience (minimum 2 years).

What you will learn

  1. Knowledge of alternative regulatory pathways in the EU, UK and US
  2. Dynamics of development of medicines with shortened review times
  3. Preconditions for approval of medicines based on less clinical data than normally required
  4. Appliance of emergency use authorisations
  5. Use of temporary regulatory approvals

What your company will get

  1. An employee who understands the situations that qualify for abbreviated and special pathways in the EU, UK and US jurisdictions.
  2. An employee who knows the principles of development of medicines with shortened review times.
  3. An employee who is familiar with alternative approval pathways, emergency use authorisations and temporary approvals.

Course calendar

5. Nov 2021 8:15-16:45
  • Welcome and Setting the scene
  • EU approach: examples of pathways with discussion of medical need
  • US approach: examples of pathways with discussion of medical needs
  • UK approach: examples of pathways with discussion of medical need
  • EUCOPE perspective: comparing and contrasting EU with other regions
  • Workshop (case study): establish a roadmap for specific disease examples
  • Wrapping up the day
Practical information

Registration

Registration deadline
30. Oct 2021
Atrium
Lersø Parkallé 101
2100 København Ø
Sometimes things change. This is the expected programme.

Course leader(s)

Inger Mollerup
Independent Regulatory Consultant
Inger Mollerup Regulatory Consulting

Lecturers

Jens Heisterberg
VP, Regulatory Policy and Intelligence
Novo Nordisk A/S
Lucia D'Apote
EUCOPE R&D Topic Lead, Scientific advice, PRIME, RWE/Big data
Amgen Ltd., UK
Robert Babilon
President
Prosoft Clinical
Christian Schneider
Head of Biopharma Excellence and Chief Medical Officer (Biopharma)
PharmaLex Denmark A/S
Ida Sofie Jensen
CEO of The Danish Association of the Pharmaceutical Industry
Lif

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Want to know more, or need help?

Contact Client Manager Mette Ribergaard Rasmussen at +45 39 15 09 30

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