Ditte Zerlang Andersen Email & Phone Number

Frederikssund, DK

In our Centre for Medicines Licensing & Pharmacovigilance, my focus is to connect the needs from our business with our environment and find the best ways forward. With a strategic approach, I lead clarification and help set direction for deliverables in important innovation areas relevant to our business with involvement of internal and external.

Copenhagen, Capital Region, Denmark

From our clinical trials unit, I establish, initiate and faciliate strategy projects in our EU regulatory environment with the aim to optimise or solve challange in our regulatory environment around clinical trials with medicinal products. The role requires strong analytical, communication and interpersonal skills to set direction and lead change across.

Copenhagen, Capital Region, Denmark

I lead strategy projects across our EU clinical trials environment anchored in the Clinical Trial Coordination Group (CTCG). I established and lead the CTCG sub-group 'Project and Portfolio Management', where I have implemented strategy project management as a tool for solving complex strategic challenges across our EU medicines regualtory network (EMRN).

Copenhagen Area, Denmark

In the role of clinical trial assessor, I assessed clinical trial applications (CTAs) in the context of regulatory compliance and trial subject safety. The assignment included assessment of clincial trial documents and reportings such as clinical trial protocol, amendments, Investigator’s Brochure (IB) and suspected unexpected serious adverse reactions.

Valby DK

Assignments included coordination of regulatory activities for MAA and CTA submissions and responsibility for the administrative part of partner collaboration ensuring optimal transfer of regulatory documents and alignment of regulatory processes across companies. From life cycle management on established products, I have experience with variations.

Ballerup DK

As part of a team, I migrated worldwide registration information on marketed products from multiple systems and archives into a Regulatory Information Management System (RIS). The task gave me a good introduction to the regulatory nomenclature and dossier structure with focus on the module 3 quality documents.

Valby DK

I evaluated preclinical EEG biomarkers in transgenic mouse models of Alzheimer’s Disease. The work was performed within the EU Innovative Medicine Initiative (IMI), Pharmacog, where I interacted with scientists across clinical and preclinical sites in Europe from industry to academia.

Måløv DK

In the department of Histology, I was responsible for the experiments carried out by a technician and investigated the expression of new inflammatory targets in human disease tissue by immunohistochemistry.

Copenhagen Area, Denmark

I completed ongoing studies initiated during my PhD on the regulation of alpha 7 nicotinic receptors upon acute and chronic agonist administrations by applying autoradiographic binding and in situ hybridization.

Title: "Pathological alterations induced by intraneuronal Abeta in Alzheimer´s disease". The work was performed in transgenic mouse models applying histology, stereology, image analysis, and autoradiographic receptor binding.The PhD was fínanced by the EU Marie Curie actions and was performed as part of the PhD school NEURAD (www.neurad-alzheimer.de).

Establishment of autoradiographic binding assay for alpha 7 nicotinic receptors and investigations in AD mouse models.

I worked with functional and ligand binding receptor autoradiographystudying the NPY system after acute and chronic electroconvulsive seizures in mice.

Strategy Consultant

Msp Programme Management Certification, Msp Certification

Ipma Project Management (Level C), Ipma (Level C) Extended Exam

Doctor Of Philosophy - Phd, Neuroscience, Summa Cum Laude

Phd, Neuroscience

Title: "Pathological alterations induced by intraneuronal Abeta in Alzheimer´s disease". The work was performed in transgenic mouse models.

Msc, Human Biology

Erasmus: Neuroscience, Endocrinology, And Immunology

Bachelor, Chemistry/Biotechnology