How it Impacts Pharmaceutical Companies and How to Ensure Compliance


Date: 27 November 2018
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 1 - Day Course
Hours: 9:00 – 17:00
Price: 1,950 NIS + VAT
Credit Points: 1
SKU: 18982
Course Language: English
About the Course
The EU General Data Protection Regulation (GDPR) became effective on 25 May 2018, bringing new challenges for global pharmaceutical sponsoring, processing and reporting clinical trial and and/or post-marketing pharmacovigilance data associated with EU citizens. In recent years, the pharmaceutical industry has been hyper-diligent in protecting personal information of subjects involved in clinical research as well as post-marketing activities and all that comes with managing global organizations, products, advertising, and safety reporting. We have validated, redacted, encoded, and safeguarded in what seems every way possible. But now there is more! Companies outside of the EU that are conducting clinical trials and/or have marketed products within the EU are required to follow the GDPR.
Don’t get caught off guard!

At the completion of this session, you will be able to:
  • Execute a gap analysis to identify how the GDRP will specifically impact your company
  • Identify strategies for closing any gaps you have identified
  • Determine how to best document your gap analysis and strategy to demonstrate your due diligence considering that all may not be in place by May 25th
Who should attend
This course will be of benefit to employees working in a GCP regulated environment who set strategy for, manages, executes, and/or audits activities involving processing of EU subject or customer data.  This includes personnel in:
  • Quality Systems (Quality Assurance, Training, Document Management, etc.)
  • Clinical Development
  • Data Management
  • Information Technology
  • Pharmacovigilance
  • Medical Affairs
  • Call Centers
  • Consumer Research
  • Other functions that handle subject or customer data
How it Impacts Pharmaceutical Companies and How to Ensure Compliance
Benefits to the Participants
  • Gain an understanding of the GDPR terms and concepts
  • Learn how the GDPR impacts Clinical Trial Management and Documentation
  • Learn how the GDPR impacts Post-Marketing Safety Surveillance and Pharmacovigilance activities
  • Acquire strategies for managing organizational, process, and document changes needed for GDPR compliance
  • Obtain GDPR-related templates that can be used immediately for GDPR gap analysis and mitigation planning, execution, and documentation.
Contact us
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Issues to be covered
  • Introduction to the GDPR
  • Historical overview of pharmaceutical-related requirements for safeguarding personal data
  • New terms and concepts introduced by the GDPR
  • The expanded rights of data subjects under the GDPR
  • The impact of the GDPR on long-standing clinical trial and post-marketing pharmacovigilance regulations and industry standards
  • New company roles and responsibilities introduced and required by the GDPR
  • Informed Consent of Data Subjects and how it overlaps with clinical trial informed consent
  • The GDPR Impact to vendor relationships, contractual agreements and oversight
  • How to handle data breaches following the GDPR
  • How scientific and statistical data are addressed by the GDPR
  • How to create and document a compliance strategy as soon as possible
About The Lecturer

Ms. Penelope Przekop

Penelope Przekop, RQAP-GCP, is a Quality Management Systems, Assurance & Compliance Consultant with 25 plus years of experience in Pharmaceutical GXP Global Quality Systems with key focus in clinical research and development, data management, computer systems validation, and pharmacovigilance. Her areas of expertise include quality systems quality assurance, regulatory compliance, inspection readiness, training, and strategic planning for quality.
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