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GDPR and Implications on Drug Development - Webinar


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Who should attend?

Anyone working in clinical trials, including managers and quality assurance personnel, seeking to gain knowledge of the GDPR requirements applicable to clinical trials. It is also applicable to those who currently have a role in data protection or information security and need to understand how to comply with the regulation within a clinical trial context.

Details

Course overview

The General Data Protection Regulation (GDPR) came into force on 25 May 2018 and brought substantial changes to the rules around personal data and its use. Most companies have implemented the requirements, such as creating records for personal data processing activities and preparing data protection assessments.

However, while the GDPR built on existing data protection legislation, it represented a significant change for organisations that hold and process personal data including clinical trial data. Also, the requirements apply to companies based within and outside of the EU, including the US.

To ensure effective compliance, pharmaceutical, biotechnology and device organisations, universities and hospitals involved in clinical trials and vendors (including CROs) need to ensure management and staff understand the GDPR requirements and are well equipped to plan, implement and maintain a data protection compliance programme for running clinical trials. Organisations collecting clinical trial data will also need to appoint a suitably qualified and trained data protection officer (DPO).

This webinar on the GDPR will help you understand how it will apply to clinical trials with a 1 hour presentation, followed by a discussion session.

By attending this webinar you will be able to check compliance with the new regulation, as well as understand the key areas, concepts, principles, terms and definitions used in the GDPR relevant to drug development and in particular clinical trials. The session will help you develop your awareness of non-compliance potential fines: 4% of global annual turnover or €20 million.

Learning outcomes

Key webinar objectives

  • Ensure your understanding of the General Data Protection Regulation (GDPR)
  • Review implementation of the main principles of GDPR which impact on clinical trials
  • Consider data breaches and how to avoid these
  • Understand the role of the Data Protection Officer (DPO)
  • Clarify how the new rules around GDPR should have been implemented in your organisation
  • Understand how to identify potential impacts of privacy challenges when running clinical trials
  • Review the new governance and technical steps in your organisation to comply with the GDPR requirements

Who should attend this webinar?

Anyone working in clinical trials, including managers and quality assurance personnel, seeking to gain knowledge of the GDPRrequirements applicable to clinical trials. It is also applicable to those who currently have a role in data protection or information security and need to understand how to comply with the regulation within a clinical trial context.

Session topics

  • Overview and background of the EU General Data Protection Regulation (GDPR)
  • Understand how it applies to clinical trials and the pharma industry
  • ‘Special Categories of Personal Data’ and clinical trial data
  • The rights of clinical trial subjects, Including data access requests, informed consent
  • Controllers & processors
  • Reporting data breaches
  • The role of the Data Protection Officer (DPO)
  • Transferring clinical trial data outside the EU
  • Penalties
  • Considerations for governance to comply with the GDPR requirements

Prices

TBC

Contact

Leigh White
info@management-forum.co.uk

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