Data Transparency in Clinical Trials and Fake News In-house Training

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.

EVENT INTRODUCTION

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.

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

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Comprehensive overview with very knowledgeable and experienced trainers. The break-out sessions were great as they made the course more interactive and allowed us to apply the concepts in practice.

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