Presented by
Management Forum

GDPR and Implications on Drug Development - Webinar

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

Find out more

  • Format: Bespoke training
  • CPD: 6 hours for your records (depending on your requirements)
  • Certificate of completion

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.

Laura Brown

Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and Training Consultant, Course Director for the MSc in Clinical Research at the University of Cardiff, and MSc Regulatory Affairs, TOPRA. She has more than 19 years’ experience in the pharmaceutical industry and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has worked in Drug Development, Clinical Research, Quality Assurance and Marketing and has a particular expertise in Clinical Research and GCP issues. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on clinical research issues and ICH GCP, is author of SCRIP’s GCP guide and is a member of the editorial board of the Good Clinical Practice Journal. She is co-author of several books on management including ‘Developing the Individual’, 'The Ultimate Book of Business Skills’ and ‘Pharmaceutical Project Management’.

More details

We don't have any currently scheduled dates for this course but we can customise it to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

See below or contact us to discuss yor requirements.

UK

  • Britannia Pharmaceuticals
  • CellCentric Ltd
  • Emas Pharma Ltd
  • Hansa Medical AB
  • Kowa Research Europe Ltd
  • NDA Regulatory Science Ltd
  • Novo Nordisk A/S
  • PA Consulting Group

United States of America

  • Arrowhead Pharmaceuticals
  • Tetraphase Pharmaceuticals
  • Verastem

Denmark

  • Ferring Pharmaceuticals A/S
  • Orifarm Generics A/S

France

  • AVADEL RESEARCH
  • Pixium Vision

Ireland

  • Acorn Regulatory Consultancy Services Ltd
  • Real Regulatory Limited

Netherlands

  • dada consultancy
  • DADA Consultancy BV

Austria

  • G.L. Pharma GmbH

Finland

  • Faron Pharmaceuticals Ltd

Germany

  • Olympus Europa SE & Co KG.

Greece

  • Pharmaserve Lilly SACI

Macedonia, The Former Yugoslav Republic Of

  • Alkaloid

Switzerland

  • ObsEva S.A.

Ukraine

  • JSC Farmak

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy