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Olga Stoll

Bayer

Olga is Digital GxP Compliance Manager at Bayer, located in Basel. In her role she is responsible for ensuring compliance for digital solutions including mobile health, Artificial Intelligence and future technology solutions through identification of compliance issues by performing GxP system, IT supplier and IT Service Provider audits, design of mitigation measures and orchestration of digital compliance management processes within the scope of GxP IT systems’ Lifecycle Management. Olga has 18+ years of experience within the pharmaceutical industry. She worked in the analytical drug substance development and Quality Management departments. She is a laboratory technician by training, held a BSc in Chemical Engineering from Provadis School of International Management and Technology Frankfurt and successfully completed a MSc in Quality Management in Scientific Research and Development at the Cranfield University.


Abstract

A STORY ABOUT FIT EDDI AND THE COMET

Mobile apps, digital therapeutics and personalised medicine, telehealth and telemedicine, artificial intelligence (AI) and Big Data, advanced analytics, mobile health (mHealth), wearable devices, health information technology (Health IT) are new evolving trends which are summarised by the Food and Drug Administration (FDA) under the term ‘Digital Health’. To stay competitive, the pharmaceutical industry has started implementing strategies for moving this topic forward. The digital strategies are encompassing goals for speeding up clinical trials, for increasing data quality, increasing efficiency in operations through process automation, and for enabling of data-driven decisions.

Digital transformation has been a buzzword for the last couple of years now and is very broad in the healthcare sector. Arthur A. Boni predicts in his article for biopharma more ‘converged solutions that merge drugs & diagnostics… and devices, and digital technologies (including social media) to impact and connect the entire healthcare ecosystem which is customer/user-centric’. The adoption of big data and machine learning, robotics, artificial intelligence, and the Internet of Things (IoT) are impacting the industry and business models. Different technologies have been combined with the goal to reach better results.

Data has become the key to successful digital transformation. The amount of data is constantly growing through technological developments and additional or improved data collection methods. However, data collection alone is not enough. Data needs to be aggregated, algorithms developed and applied, the outcomes analysed and assessed in order to be able to make sense of all available data and to benefit from that information. This presentation will deal with changing landscapes in pharmaceutical industry in general and with new IT audit approaches in particular. Where are we standing now? What is expected and required by Health Authorities? How your new IT audit approach could look like? What are typical challenges? Listen to a story about FIT EDDI and the COMET and find out how to open up opportunities and to keep pace with technological developments.

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