Some of the hot topics
Over the past decade, implementing disclosure and data transparency policies and procedures in clinical trials has become an essential requirement for anyone working in this area. Most of the major pharmaceutical companies have already established transparency policies, spontaneously giving the possibility to access the data collected during their clinical trials to anyone who requests it; at the same time, regulatory agencies such as European Regulatory Agency Policy (EMA), FDA, and the International Committee of Medical Journal The editors (ICMJE) have made the effective management and publication of data collected in clinical trials mandatory.
The management of confidential company data and patient personal data by the study sponsor must therefore be redefined; these requests will translate into an additional workload for those working in the world of medical research, which must however be turned into a new opportunity of adding value to scientific communication. This workshop aims to provide practical tools to manage new requests proactively and effectively in terms of data transparency in clinical trials, producing benefits that go beyond compliance with the rules.
Get to know the Trainers
Carla is a biologist that, after over 20 years of experience in the generation, collection, storage, and communication of clinical data, has moved her activity to scientific communications. Her
multiple customers include Italian and multinational pharmaceutical, para-pharmaceutical, medical-surgical devices, and diagnostics companies. She has been a professional writer certified by the International Society for Medical Publication Professionals (ISMPP) acting as a trainer for healthcare personnel
Andrea has a degree in Biology from Florence University. After a brief spell at the University, he started working in the Italian Affiliate of Eli Lilly as a Clinical Research Associate. In the years that
followed he was responsible for Statistics, Health Outcomes, and Medical Information. Andrea has been working as Medical Writer since 2003 beginning in Italy and then has had growing responsibilities until he was responsible for worldwide scientific affairs in a biosimilar company based in Switzerland.
He is the author of more than 350 disclosures and is acknowledged for his contribution to several others. From 2007 to 2009 hewas on the coordination board ofBIAS (Biometristi ItalianiAssociati)
and has been a European Medical Writers Association (EMWA) member since 2004. Andrea acts as a trainer for statistics and medical writing in some Italian specialisation medical schools and
has been a speaker at national and international conferences. Andrea leads workshops for and is an ambassador and past president of EMWA.
Feel free to suggest the topics that you would like to learn about at
our Data Transparency in Clinical Trials and Fake News In-house Training.
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Who should attend?
The course is aimed at all company figures involved in the design, development, and
communication of clinical studies on products of medical interest, including professionals
working in:
• Clinical Operations
• Regulatory
• Medical Affairs
• Clinical data registration
• Statistics
• Scientific Communications
• Medical Information
• Clinical Information
• Marketing
• Compliance
• Quality assurance
• Pharmacology
• CRM
• Transparency
• Legal
• Data management
• Real-World Data
