GDPR and Implications on Drug Development - Webinar

This webinar on the GDPR will help you understand how it will apply to clinical trials with a 1 hour presentation at 2pm (BST), followed by a discussion session

Course overview

The General Data Protection Regulation (GDPR) came into force on 25th of May 2018 and brought substantial changes to the rules around personal data and its use. While the regulation builds on existing data protection legislation, it represents a significant change for organisations that hold and process personal data including clinical trial data. 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 better prepared to comply 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 with the new GDPR regulation – potential fines: 4% of global annual turnover or €20 million.

Learning outcomes

Learning outcomes

  • Gain an understanding of the General Data Protection Regulation (GDPR)
  • Identify 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)
  • Ascertain how the new rules around GDPR apply to your organization
  • Have greater ability to identify potential impacts of privacy challenges for 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 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.

  • Pharmaceutical managers, directors working in GXP areas
  • Clinical research managers, VPs and directors
  • Quality Assurance for clinical trials /GXP
  • Study site staff
  • CROs and other vendors working on clinical trials
  • Pharmacovigilance for clinical trials
  • Data protection officers
  • IT and corporate security managers involved in GXP areas of drug development
  • Corporate governance managers responsible for clinical trials
  • Risk and compliance managers responsible for clinical trials
  • Internal legal teams with responsibility for clinical trials

Session Topics

  • Essential overview and background of the EU General Data Protection Regulation (GDPR)
  • Understand how it will apply 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

In-house Training and Consultancy Services

This webinar can also be ran In-house

Coming to Management Forum for your in-house training provides an all-inclusive service which gives you access to a wide variety of content, learning platforms and delivery mechanisms as well as your own personal training adviser who will work with you from the initial enquiry through to feedback and follow-up after the programme.

With over 600 trainers, all practitioners and experts across a huge range of fields, we can provide the training you need, where you need it, when you need it, and at a price which suits your budget. Our approach to tailored learning and development consists of designing and delivering the appropriate solution for each client.

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

Previous customers include...

  • Acorn Regulatory Consultancy Services Ltd
  • Alkaloid
  • Arrowhead Pharmaceuticals
  • Britannia Pharmaceuticals
  • CellCentric Ltd
  • Emas Pharma Ltd
  • Ferring Pharmaceuticals A/S
  • G.L. Pharma GmbH
  • Hansa Medical AB
  • JSC Farmak
  • Kowa Research Europe Ltd
  • NDA Regulatory Science Ltd
  • Novo Nordisk A/S
  • ObsEva S.A.
  • Olympus Europa SE & Co KG.
  • Orifarm Generics A/S
  • PA Consulting Group
  • Pixium Vision
  • Real Regulatory Ltd
  • Tetraphase Pharmaceuticals
  • Verastem