Data Protection Workshops

Data Protection –
Module 3

Tailored for stakeholders with basic knowledge and experience in the field of GDPR Compliance or General Data Protection Compliance. Education Session / Workshop is focused on Pharmacovigilance .

Suggested participants Clinical Trial Sponsors (for Clinical Safety), MAHs (for post marketing case processing, Medical Information, etc.)

  • Applicable Data Protection Regulation/Legislation: Extraterritorial Application of the GDPR, Local Specifics
  • Personal Data Protection Fundamentals: What is Personal Data, Examples, Categories of Personal Data, Special Categories of Personal Data, Common misconception, Data Subjects
  • Processing Roles Allocation: Data Controller vs Data Processor, Responsibilities, Sponsor vs CRO vs MAH vs Pharmacovigilance Providers
  • Categories of the Data Subjects: Patients within Clinical Trials, PI and PI’s team, Reporters, Patients outside the Clinical Trial
  • Data Protection Officer vs EU GDPR Representative: Data Protection Representative vs Legal representative
  • Data Processing Principles
  • Legal Basis for Processing and Purpose: Consent or Legitimate Interest for Clinical Safety, Public Interest, Legal/Regulatory obligation
  • Consent: Processing Consent vs Informed Consent Form in Clinical Safety, Personal Data Information Notices in Post-marketing Pharmacovigilance
  • Records of Processing Activities: Obligation to maintain RoPA; Responsibilities; Characteristics of RoPA
  • Data Protection in Case Processing
  • Data Protection in Medical Information
  • Data Protection Compliance in Literature Screening
  • Data Breach Management: Personal Data Breach Management, Confidentiality Breach Management, Security Breach Management
  • Data Subject Requests Management
  • International Transfers: Appropriate Safeguards in Pharmacovigilance, List of Adequacy, New European Commission’s SCCs, Other Transfer mechanisms
  • Data Retention in Pharmacovigilance
  • Data Processing Agreements with Third parties (CDAs, MSAs, CTAs, DPAs, DSAs, SDAEs)
  • Vendor Management
  • Security of Data: Technical and Organizational Measures
  • Data Protection Non-Compliance Consequences

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