Elizabeth Hernberg-Stahl, speaking at Late Phase Drug Development World Europe 2011

Elizabeth Hernberg-Stahl,
Senior Consultant
Late Phase Solutions Europe AB

Elizabeth Hernberg-Ståhl has almost 20 years of international experience from Pharmaceutical Industry in developing and managing global patient registries on rare orphan diseases.

She has during these years gained an in-depth expertise in designing and managing patient registries within the area of rare orphan diseases. This includes assuring fulfilling the needs of different stakeholders as authorities, physicians and patients’ point of view, as well as the commercial needs of the pharmaceutical companies.

Until early 2010, Elizabeth was the Director of Global Outcome Surveys Shire HGT, a position she held for almost 10 years. During that period Elizabeth was responsible for establish and building the Global Outcome Survey function in its entirety with functions including Global and Regional Project Mangers, Application Development, Data management, Quality Assurance and Biostatistics.

The department managed global patient registries on some rare disorders, Fabry Disease Hunters Syndrome and Hereditay angioedema (HAE). These initiatives are run in close collaboration with treating physicians and experts within the field and the objective is to collect “real world” information on both the natural history of these diseases and the outcome of patients receiving Shire HGT products; Replagal, Elaprase and Firazyr respectivly. The data are continuously analyzed in order to optimize patient treatment.

Elizabeth was also member of the Shire HGT European Management team and the Global Medical Affairs Leadership Team.

Appearing:

Pre-conference workshop

9am

Overview:

Innovative solutions to data capture

This interactive workshop will review different technical innovative solutions in data capture; eg. Smartphones, and the advantages/disadvantages of their application. The day will then demonstrate real world scenarios and different approaches for using these data capture tools. Attendees will come away from this workshop with practical and usable information to share with their
product teams.

The workshop will begin at 09:00 and end at 16:00. Lunch and refreshments will be provided.

Workshop content
• Treatment centred Phase III Clinical Trial & Phase IV Post Marketing Surveillance studies
• Patient centred Electronic Records and Management Systems
• Community wide Electronic Health Records
• Health Informatics Methodology
• Data collection flow of current real world processes with desired enhacements
• Developed applications in Endocrinology, Genetics, Oncology, Ophthalmology
• Specific disease areas of Growth deficiency and
Acromegaly
• Rare diagnoses including Fabry and Hunter Syndrome

Elizabeth Hernberg-Stahl,

Senior Consultant,
Late Phase Solutions Europe AB

Jani Söderhäll,

Founder,
PCPal

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