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
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.
Key webinar objectives
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.
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.
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