Dialogue seminar

Market Access for Regulatory Affairs and Regulatory Affairs for Market Access

Why do we need a closer collaboration between regulatory affairs and market access?

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.

"Market Access for pharmaceuticals is becoming increasingly challenging based on a greater need of data to meet market access requirements. Regulatory professionals need to build market access requirements into their regulatory strategy at an early stage of development," says Vibeke Hatorp, Senior Director, Regulatory Affairs, Novo Nordisk A/S

In October we host a dialogue seminar that will help you understand why your company can benefit from a closer collaboration between regulatory affairs and market access. 

”Innovative pharmaceuticals can no longer successfully be brought to market without a thoroughly coordinated regulatory and market access strategy. The challenge today is not that we are unaware that both aspects are essential, but rather that we do not know how we enable efficient collaboration between regulatory affairs and market access to benefit both the regulatory approval and help get to the patients, ” says Martin Strandberg-Larsen, Director, Global Market Access, H. Lundbeck A/S.

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

Date: 23. October 2018


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