GDPR and Implications on Drug Development - Webinar

This one hour webinar will help you understand what has the impact of GDPR been on drug development
25 February 2019 – 2pm (GMT)

25 Feb 2019

GBP 99
EUR 139
USD 154

Book now

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 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.

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

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.

Presenter

Laura Brown

Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance and regulatory requirements in clinical trials in the pharmaceutical industry. She has worked in senior positions for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including data protection and data integrity in clinical trials. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues in clinical trials

Book now

25 Feb 2019
25 Feb 2019 Online, GBP 99.00
EUR 139.00
USD 154.00
+ VAT @ 20.00%
Enrol now

Previous customers include...

  • Acorn Regulatory Consultancy Services Ltd
  • Alkaloid
  • Arrowhead Pharmaceuticals
  • AVADEL RESEARCH
  • 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
  • PHARMASERVE LILLY SACI
  • Pixium Vision
  • Real Regulatory Ltd
  • Tetraphase Pharmaceuticals
  • Verastem