Hanne has been with NDA since 2017. She supports companies with regulatory strategies to optimize the planning of the development activities and to minimize the time for product development until product launch. The support includes pre-filing activities, guidance during the review phase and post-approval activities. Hanne has experience in several therapeutic areas and with small and large molecules. She has led or contributed to successful marketing authorization procedures for several medicinal products.
Key Areas Of Expertise
- Extensive experience with planning and submission of marketing authorisation applications in the EU
- Submitted several applications via the centralised procedure, the mutual recognition procedure as well as the decentralised procedure
- Involvement in several pre-submission activities
- Scientific advice (National and EU Scientific Advice)
- PRIME request
- Pre-submission meeting
- Coordination of all submission related activities during the assessment
- Clarification Meeting
- Oral Explanation
- Scientific Advisory Group Meeting
- Strategic development and submission of paediatric investigation plans
- Provided strategic input and coordination of several paediatric investigation plans including waiver requests and/or partial waiver requests.
- Strategic input to life cycle management activities
- Variations, PSURs, renewals, change of marketing authorisation holder, ODD annual reports
Hanne worked in big pharma and at the national competent authority in Denmark in the licensing department.
In the pharma industry, she was a Sr Director responsible for the development and registration of products within a broad range of therapeutic areas. She has been responsible for the development strategy and has attended several agency meetings including oral explanations, meetings with the EMA Scientific Advice Working Party etc.