Compliant Pre-Launch Activities with Politicians, Patients, Payers, and the Media

Keep your pre-launch activities with these key stakeholders compliant

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21 May 2025

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On location

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Danish

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6,700 DKK ex VAT

(app. 901 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

How can you collaborate compliantly with patients, patient organisations, influencers, and other third parties? How should the dialogue and collaboration with officials, politicians, and media be to meet the transparency requirements?

What is legal and compliant?

All your launch-related activities, whether you work in Public Affairs, Medical Affairs, Market Access, Commercial, or another field, must comply with the Danish legislation and the industry's ethical code.

How compliant are your pre-launch activities?

Get a compliance check of your activities and dialogue with patient associations, patients, influencers, officials, politicians and media before launch.

We work with real-life cases and provide the latest decisions from the Danish Medicines Agency and ENLI.

Keywords

  • Early launch activities
  • Marketing compliance
  • Disease awareness

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Course leader & lecturers

  • Elisabeth Gammelgaard Ludvig
    Course leader
    Owner
    Sundhedsagenda
  • Louise Bertelsen Forman
    Course leader
    Partner, Attorney-at-law
    Loeven Advokatfirma
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Is this course for you?

This course is relevant for
  • Medical Affairs professionals
  • Public Affairs professionals
  • Commercial Managers
  • Market Access managers
  • Patient Engagement Managers

What you will learn

  • Through cases and rulings, you will learn how to collaborate and communicate with key external stakeholders within the legal & ethical guidelines.
  • The significance of the Patient Organisation and Lobby Codes for collaboration projects.
  • The promotional code and rules for using influencers in connection with launches
  • Compliant dialogue with the media

What your company will get

  • An employee who can work in a compliantly with patient organisations, patients and influencers
  • An employee who can work compliantly with government officials and politicians.
  • An employee who can work compliantly with media contacts.
  • An employee who understands the dos and don’ts of liaising with external stakeholders before and during the launch of a prescription drug.

    Course calendar

    21 May 2025 9:00-16:00
    • Compliance pre- and during launch in collaboration with patient organisations, patients, influencers, politicians and the media.

    • We do case work related to the following situations:
      • Meeting and collaborating with patient organisations
      • Support and donations to patient organisations
      • Training of patient organisations
      • Using patients or ambassadors in PR & advertising such as videos, leaflets & social media
      • Collaboration with influencers
      • Fair market value 

    • Compliant pre-launch activities in collaboration with decision-makers including review of regulations and casework on:
      • Dialogue and emails to politicians and officials
      • Analyses & white papers
      • Conferences, hearings & roundtables
      • Collaboration with HCPs regarding the communication to officials and politicians

    • Casework regarding the dialogue and materials for the media:
      • Collaboration with HCPs regarding the communication to patients and the public
      • Compliant contact with journalists and collaboration with patient organisations, patients and HCPs in contact with journalists
    You also get the latest case decisions from ENLI and the Danish Medicines Agency.

        Practical information

        Registration

        Registration deadline
        14 May 2025
        Atrium
        Lersø Parkallé 101
        2100 København Ø
        Register
        21 May
        Sometimes things change. This is the expected programme.

        Course information

        Literature

        Before the course, you can access mandatory and/or optional readings through your Atrium log-in.

        Prerequisites

        This course requires prior knowledge of Danish marketing regulations, ENLI's codes of sponsorship, donations, lobbying, and patient organisation. It can be found here: https://www.enli.dk/en/rules

        Examination

        There is no examination for this course; however, it is an eligible part of the Diploma in Marketing Compliance.

        Course leaders

        Elisabeth Gammelgaard Ludvig
        Owner
        Sundhedsagenda
        Louise Bertelsen Forman
        Partner, Attorney-at-law
        Loeven Advokatfirma

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        Want to know more or need help?

        Contact Client Manager Ida Salicath at +45 39 15 09 46

        Send me a message