Morning coffee meeting: the first practical experiences with the new EU Regulation on clinical drug trials

Are you ready to work according to the new European rules for drug trials from 31 January 2023?
8. Dec 2022

On location

Danish

0 DKK ex VAT
(app. 0 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

Do you work with clinical trials in the public or private sectors?

At this morning meeting, you will get insights into the most recent concrete experiences with the new European legislation on clinical drug trials, which will enter into force on 31 January 2023 – e.g. how did the first audit visits from the EMEA go?


This morning you will hear about the experiences from three different perspectives presented by skilled presenters:

  • The authorities: The Danish Medicines Agency and the National Center for Ethics
  • Hospital sector: Rigshospitalet
  • Industry: Novo Nordisk

It will be an active meeting where you can ask the presenters questions and discuss with like-minded professionals.

So come along to this free morning meeting: listen, learn, discuss, and get motivated to start working with the new regulation.


Key words

  • New EU Regulation on drug trials
  • Clinical trials
  • Audit
  • EMEA
Read more

Course leader(s) & Lecturer(s)

  • Lene Grejs Petersen
    Course leader
    Chefkonsulent
    Lægemiddelstyrelsen
  • Karen Kiilerich
    Course leader
    Specialkonsulent
    National Videnskabsetisk Komité
  • Julie Kønig
    Lecturer
    Senior Regulatory professional
    Novo Nordisk A/S - Novo Allé
  • Mia Ravn Jakobsen
    Lecturer
    Læge og Ph.d. studerende
    Rigshospitalet
  • Anne Katrine Rask
    Lecturer
    Principal Competency development specialist
    Novo Nordisk A/S
  • Annika Axholm Vedsmand
    Lecturer
    Global Senior Regulatory Associate
    Ferring Pharmaceuticals A/S
  • Charlotte Louise Samsø
    Lecturer
    Senior Regulatory Associate
    Zealand Pharma A/S
See all

Calendar

8 Dec 2022 8:00-11:00

08.00 - 08.15
Morning coffee and networking

08.15 - 09.45
Authority perspective

  • 08.15 - 08.45 Lene Grejs Petersen, Danish Medicines Agency
  • 08.45 - 09.15 Karen Kiilerich, National Center for Ethics.
  • 09.15 - 09.30 Discussion

09.30 - 09.45
Break

09.45 - 10.15
Public body - Rigshospitalet

  • 09.45 - 10.05 Mia Ravn Jakobsen, MD Student Heart Center Rigshospitalet
  • 10.05 - 10.15 Discussion

10.15 – 10.55

Pharmaceutical company – Novo Nordisk

  • 10.15 - 10.45 Principal Competency Development Specialists, Anne Katrine Rask and Julie Kønig
  • 10.45 - 10.55 Discussion

10.55 - 11.00
Round-up and thank you

Practical information

Registration

Registration deadline
5 Dec 2022
Atrium
Lersø Parkallé 101
2100 København Ø
Register
8 Dec
Sometimes things change. This is the expected programme.

Course leader(s)

Lene Grejs Petersen
Chefkonsulent
Lægemiddelstyrelsen
Karen Kiilerich
Specialkonsulent
National Videnskabsetisk Komité

Lecturer(s)

Julie Kønig
Senior Regulatory professional
Novo Nordisk A/S - Novo Allé
Karen Kiilerich
Specialkonsulent
National Videnskabsetisk Komité
Lene Grejs Petersen
Chefkonsulent
Lægemiddelstyrelsen
Mia Ravn Jakobsen
Læge og Ph.d. studerende
Rigshospitalet
Anne Katrine Rask
Principal Competency development specialist
Novo Nordisk A/S
Annika Axholm Vedsmand
Global Senior Regulatory Associate
Ferring Pharmaceuticals A/S
Charlotte Louise Samsø
Senior Regulatory Associate
Zealand Pharma A/S

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Want to know more, or need help?

Contact Client Manager Christina Spangsberg at +45 39 15 09 22

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