Governare la Privacy nella Ricerca Clinico-Scientifica. Esperienze e Strumenti pratici per Mappare il Flusso Dati, Creare e Mantenere il Registro dei Trattamenti, Effettuare la Valutazione di Impatto e Formulare Istanze di Consultazione preventiva
Medical Affairs is the strategic face of the company, be it a pharmaceutical company or a medical device manufacturer. It is a function that has taken on a new dimension in recent years, following the significant revolution in the life sciences world. Innovation in digital technologies and biological sciences is evolving at lightning speed, bringing with it an unprecedented amount of data.
Medical Affairs professionals, having among their skills; medical expertise, scientific know-how and credibility among stakeholders, are increasingly recognised as natural "owners" of scientific knowledge and data inside and outside the company.
Between 2017 and 2018, we produced 90% of the total amount of data ever existed (1). There are 2.5 quintillion bytes of data created each day at our current pace (2). Still, knowing the amount of data created every day means nothing if we don't know how to use it strategically. This imposes an urgent need to put the ability to understand, analyse, process, and communicate scientific data back at the company's heart.
This implies a significant evolution of business models, both around a pharmaceutical product or a medical device and beyond the product to a broader therapeutic context. Consequently, the analysis of more structured and complex patient data has become central, e.g., supporting decisions concerning the use of a given product or demonstrating its value to the patient in a real-world context.
To address these changes and innovations, together with the thirst for data that brings actual added value, Medical Affairs is using a range of strategies and approaches: from Real-World Evidence to electronic medical records, also using new data sources and structures such as associated genomics and innovative tools for data collection, analysis and interpretation.
What are the goals of the Medical Affairs?
In the coming years, Medical Affairs will have to:
- Drive a data generation process that is fast and integrates with other areas of the business
- Develop and articulate the clinical and economic value of the product to reinforce its presence in the market and confidence in stakeholders and accelerate access to treatment to ensure that the right patient gets the right treatment at the right time
- Improve the decision-making process of doctors and patients by involving third parties such as suppliers
- Set a strategic vision that generates significant medical impact for the company
Medical Affairs training
Medical Affairs comprises clinical research, development, disease awareness, communications and liaison roles, scientific publications, and medical evaluations, all shaping the world of pharma and medical devices of today. Courses on Medical Affairs address this ever-changing field and are designed for professionals responsible for managing drugs/devices within the area. Through our Medical Affairs workshops, seminars, and hands-on sessions, one may increase the knowledge and expertise needed to overcome the challenges of this role daily.