Elisabeth Hildebrandt-Eriksen

Nonclinical regulatory responsible for ALK product portfolio for allergy immune therapy (AIT). Regulatory team member on development project teams. Creation of submission documentation, regulatory intelligence, strategy and authority interaction packages. Cross-organizational interactions/support, internal/external communication and knowledge sharing.

Regulatory Affairs of Allergy Immune Therapy (AIT), specialized in non-clinical issues, maintenance of submission documentation, start-up of new projects. Regulatory intelligence and guidelines, QMS for non-clinical area. Cross-organisational interactions, internal/external communication and knowledge sharing, ad hoc support.

Regulatory Affairs of Allergy Immune Therapy, specialized in non-clinical issues, maintenance of supporting documentation for files and start-up of new projects. QMS for non-clinical projects and guidelines. Experienced in cross-organisational interactions,

Drug safety assessment. Design, planning, execution, review of non-clinical toxicology studies at CRO's to support obesity and diabetes development projects.

Design, planning, execution, review of preclinical safety studies to support initial phases of clinical trials with LNA oligonucleotides for oncology and infectious diseases. Regular participation in phase I safety committee for the assessment of safety and tolerability of an anti microRNA drug compound.

Designed and worked with CROs on non-clinical safety studies (contract, MSA, study plan), reviewed reports, presented results internally and supported IB's and due diligences.

Wriring study plans and reports, SOP review and generation of SOP system

Assisting Intl.Clin.Trial Mgr. (ICTM) involved in source data verification, trial drug distribution, CRF page design, SAE reconciliation, literature research, data reconciliation for report preparation/writing

Comprehensive curriculum for regulatory affairs during drug development and product life cycle management, including (non-)clinical development, regulatory legal base from different part of the world (mainly EU, US), regulatory ethics and policy, safety (reporting) activities, basics of quality/CMC

My motivation for writing about medicines' use during pregnancy is in alignment with the EMA policy aspiration to support use of safe and effective medication in pregnant (and breast-feeding) women as illustrated by the Guido Rasi quote and icon below. Therapy which is gauged beneficial for the mot