Compliance for Clinical Trials - are you Ready for Implementation

Training

Online

£ 118.95 VAT inc.

*Indicative price

Original amount in USD:

$ 150

Description

  • Type

    Training

  • Level

    Advanced

  • Methodology

    Online

  • Class hours

    1h

  • Duration

    1 Day

  • Start date

    Different dates available

  • Virtual classes

    Yes

Healthcare, Education, training

This webinar on GDPR will help you understand how it will apply to clinical trials, 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 clinical trials.

Facilities

Location

Start date

Online

Start date

Different dates availableEnrolment now open

Questions & Answers

Add your question

Our advisors and other users will be able to reply to you

Who would you like to address this question to?

Fill in your details to get a reply

We will only publish your name and question

Reviews

Subjects

  • Clinical Trial
  • Industry
  • Data Protection
  • Compliance
  • Healthcare
  • Medical training
  • Safety Management
  • Pharmaceutical manufacturing
  • Marketing Analysis
  • Education and training
  • Training regulations
  • Online Courses
  • CLINICAL TRIALS

Teachers and trainers (1)

Adam Fleming

Adam Fleming

Event Manager

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements.

Course programme

Overview:

Attain an understanding of the General Data Protection Regulation (GDPR).Be able to understand the key of the main tenets of GDPR which impact on clinical trials.

Consider data breaches. 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 organization to comply with the GDPR requirements.

Why should you Attend: The General Data Protection Regulation (GDPR) is new legislation that comes into force on 25th of May 2018 which brings substantial changes to the rules around personal data and its use. While it builds on existing Data Protection legislation, it represents a significant change for organisations that hold and process personal data particularly doe clinical trial data.

Areas Covered in the Session:

  • 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 includes 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


Who Will Benefit:

  • 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
  • Data Management
  • Pharmacovigilance for Clinical Trials
  • Information Security Managers
Speaker Profile
Dr. Laura Brown , PhD, MBA, Diploma Clinical Sciences, is an independent QA and training consultant in the pharmaceutical industry. She is a managing director with LB Training and Development Ltd., course director for the M.Sc. in Clinical Research, School of Pharmacy at the University of Cardiff, and course director for M.Sc. Regulatory Affairs, TOPRA. Dr. Brown has 20 years experience running clinical trials and clinical quality assurance in the pharmaceutical industry, and auditing clinical trials internationally. She has held a number of international and senior management QA positions in the pharmaceutical industry including her role as an associate director with a leading GCP audit consultancy.

Compliance for Clinical Trials - are you Ready for Implementation

£ 118.95 VAT inc.

*Indicative price

Original amount in USD:

$ 150