Summary
Ensure that your dialogue and activities with HCPs are compliant before and during the launch. What is defined as promotional when engaging with HCPs? Where and when is your communication with HCPs at risk of being seen as non-compliant advertising for a soon-to-be-launched prescription drug?
All your activities and dialogues with HCPs need to comply with Danish law and industry ethical codes on:
- Advertising for prescription medicinal products
- HCPs’ affiliation with pharma companies regardless of whether you work in Medical Affairs, Market Access, Sales or Marketing
Are your activities legal and compliant?
Join this course for a compliance check of your activities and dialogues with HCPs before and during launch.
We work with real cases and provide the latest decisions from the Danish Medicines Agency and ENLI.
Other course participants say
"The course was remarkably relevant. Very skilled and inspiring presenters - high level of knowledge!"
Vibeke Søndergaard, Compliance Manager, Effector A/S
"If you work with pre-launch products this course gives you a detailed overview of the rules and what to pay attention to."
Jesper Kildehøj, Senior Medical Advisor, Daiichi Sankyo Nordics
"Great lecturer and relevant discussion questions, which were given plenty of time for discussion. Lots of good input from the other participants."
Annette Nørgaard, Key Account Manager, Recordati AB
Keywords
Prescription drug launch
Marketing compliance
HCP interaction
Disease awareness
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Course leader & lecturers
- Elisabeth Gammelgaard LudvigCourse leaderOwner
Sundhedsagenda - Louise Bertelsen FormanCourse leaderPartner, Attorney-at-law
Loeven Advokatfirma - Julie Holtum QvistLecturerSenior Legal Specialist
H. Lundbeck A/S
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Is this course for you?
The course is for you who communicates with HCPs and/or patients as part of your responsibilities. You might work as a Medical Affairs professional, Key Account Manager, Commercial Manager, or Market Access manager.
What you will learn
- Know the important laws and regulations related to HCP interaction before and during launch
- Analyse and solve cases related to market research, advisory boards, data sharing, and HCP training programmes following relevant regulations and industry codes.
- Know the rules regulating HCP affiliation with the pharma industry and how to apply them when working with HCPs
What your company will get
- An employee who can collaborate compliantly with HCPs in the prelaunch phase
- An employee who knows the regulatory framework and ethical industry rules for dialogue with HCPs before and during launch
- An employee who knows the dos and don’ts of working with HCPs before and during the launch of a new medicine
- An employee who knows where to search for guidance and guidelines about the rules
Course calendar
- Pre and post-launch compliance in collaboration with HCPs in cases such as:
- Market research
- Advisory Boards and other consulting relationships with HCPs
- Data sharing and scientific documentation
- HCP training programmes
- Brief overview of legislation and regulations
- The DMA’s rules on Advertisement of medicinal products
- ENLI’s guide on Pre-launch activities
- The DMA’s rules on healthcare professionals' affiliation with pharmaceutical companies
- Selected ENLI codes, such as the Donation Code
- Lif's collaboration agreements with the Danish regions
- Review of the latest decisions from the Danish Medicines Agency and ENLI
- Practical case: How a pharma company works with compliance in their dialogue & collaboration with HCPs
- Collaboration or donation? When does the Donation Code come into play?
- Developing guidelines
- Supporting patient treatment
- Educational grants
Registration
Registration deadline6 May 2025
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you get access to mandatory and/or optional readings via your personal Atrium log-in.
Prerequisites
You must have completed our basic marketing compliance courses or acquired similar knowledge elsewhere. Contact us, if in doubt.
Examination
There is no examination for this course.
This course is an elective course for the Diploma in Marketing Compliance.
This course is a part of a diploma
Through the Diploma in Marketing Compliance, you will get an in-depth understanding of the rules and regulations set by both the authorities and the pharmaceutical industry in Denmark and Europe, making you sharper and more effective in your daily work
Read moreCourse leaders
Sundhedsagenda
Loeven Advokatfirma
Lecturers
Loeven Advokatfirma
Sundhedsagenda
H. Lundbeck A/S
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Contact Client Manager Ida Salicath at +45 39 15 09 46
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