Market Access for Regulatory Affairs and Regulatory Affairs for Market Access

1-day dialogue seminar

  • 23. Oct 2018

1 day course

English

3.750,- DKK ex VAT
(app. 504,- EUR ex VAT)

Summary

Getting a new product to the market and thereby providing access to new medicines for patients is becoming increasingly challenging.

To obtain regulatory approval of a new medicine is key. However, before the medicine can get to the patient the market access strategy must be successful. This requires an approvable and reimbursable file and the link between the two is getting increasingly important.

The purpose of this dialogue seminar is to identify areas of opportunity for a closer collaboration between regulatory affairs (RA) and market access (MA) during drug development and regulatory approval, to give you insights into the two disciplines and to help you strengthen your strategies for ensuring timely access of new medicines to patients.

We will bring together key stakeholders to discuss the current regulatory environment in the EU and experts from industry, HTA bodies and regulatory authorities to present and discuss perspectives and key challenges.

Take this opportunity to join an open, informal and solution-oriented dialogue with colleagues representing European regulators, health technology assessment (HTA) bodies as well as colleagues from the industry and the broader scientific community.

You will have the chance to find some common ground and exchange questions and ideas with other stakeholders involved in the process of getting new medicines to the market. 


 

Keywords

Market access in regulatory affairs
Regulatory affairs in market access
Collaboration between regulatory and market access
Dialogue

What you will learn

  1. How to build market access requirements into the drug development and regulatory processes from the very start
  2. How to involve market access in the generation of initial labelling and updates
  3. The opportunities for joint health technology assessment (HTA) and health authority (HA) scientific advice in the EU
  4. How to think of market access and regulatory affairs as key partners in a development and approval process with complex and dynamic needs
  5. The key challenges of HTA and regulatory requirements
  6. How to get a closer collaboration between market access and regulatory affairs in your organization

What your company will get

  1. A professional who has an overview and understanding of both the key challenges of HTA and the regulatory requirements
  2. A professional who is inspired to work for a closer collaboration between market access and regulatory affairs in the organization
  3. A professional who can play an important role in any project team providing strategic advice on how to incorporate both regulatory and market access requirements into the development of new medicines
Available start dates

Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call us at + 45 39 27 60 60, or send us an email at contact@atriumcph.com

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick on the day of the course, you can hand over your seat to a colleague. To hand over your seat, please contact us at +45 39 27 60 60. Read our cancellation policy.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Senior Programme Director Tina Jensen at +45 39 15 09 14

Send an email

 

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