Introduzione

The current regulatory landscape requires public disclosure of clinical trial (CT) data and documents.

The EU General Data Protection Regulations (GDPR) requires that personal data in these documents be protected. Though divergent at first glance, these new requirements actually are aligned to benefit patients. As clinical researchers, we need to find the right balance between disclosure and data protection while maintaining the scientific utility of the documents we write.

The objective of this workshop is to help clinical researchers deal with increased requirements (with focus in the EU) in data transparency and public disclosure in both pharma and medical devices.
In particular, the requirements under the EU Clinical Trials Regulation, the EU Medical Device Regulation and the EMA Policy 0070 will be discussed.

An introduction to the different public disclosure platforms, ie, EMA clinical data website, EU Clinical Trial Information System (CTIS), and the European Database for Medical Devices (EUDAMED) will be made.

  • Regulatory framework of clinical data transparency and data protection, with focus on the EU: EU CTR, MDR, IVDR, GDPR
  • Platforms and portal: EU CT Registry, EMA Policy 0070 Clinical Data Site, EMA CTIS, Eudamed
  • What need to be disclosed: information, data, documents
  • Privacy by design: how to implement these in your projects

This course is for clinical research professionals actively involved in the design, conduct, and reporting of clinical trials, especially in the EU.

Participant experience
Familiarity with clinical trials and clinical trial documents.

 

Virtual training, with interactive exercises

Docente/i
Raquel Billiones
Info

Raquel Billiones

Associate Director, Medical Writing at Alexion Pharmaceuticals (AstraZeneca RareDisease)
Raquel Billiones has a PhD in Biology and more than 25 years combined experience in scientific and clinical research. She has been a medical writer for >15 years, with core competencies in writing clinical trial and regulatory documents for pharmaceuticals and medical devices. Her core competencies include clinical trials and submissions documents, and data transparency and public disclosure balanced with data protection. Over the years, she took on a wide range of industry positions, as freelancer, as employed regulatory writer, and as head of medical writing departments in the CRO, biotech and big pharma settings. Raquel is an active EMWA member since 2006, serving in various roles. She is currently the Editor-in-Chief of the EMWA journal Medical Writing. She also serves on the Education Committee and the Executive Board of EMWA. She is currently employed as Associate Director, Medical Writing, Alexion Pharmaceuticals (AstraZeneca RareDisease).

This online training consists of 1 module:

DATE TBD

Some days before the online training you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 465,00* 

Ordinary: € 595,00*

Freelance – Academy – Public Administration**: € 370,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

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Cosa saprai fare dopo il corso
Risultato atteso
Learn about the requirements of data transparency, public disclosure and data protection
Risultato atteso
Introduce to the different public disclosure platforms, ie, EMA clinical data website, EU Clinical Trial Information System (CTIS), and the European Database for Medical Devices (EUDAMED)
Risultato atteso
Know the clinical trial documents impacted by these requirements
Risultato atteso
Gain knowledge in identifying critical patient data and the “risk areas” of a document or project, and in mitigating risks to confidentiality and of non-compliance
<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>
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Data Transparency for Pharma and Medical Devices