San Francisco Chapter Event: Clinical Trial Data Privacy and Protection- Fundamentals

This 45 minute session followed by Q&A, will inform the audience of the latest in data regulations and the potential of those regulations to impact clinical trial planning, operations and data reporting.

This webcast will:

• Describe common data privacy and protection terminology and sources of latest information
• Provide an overview of current privacy regulations and any significant changes in major regions around the world. This will include an explanation of why a focused data privacy strategy is crucial to trial success
• Share region appropriate risk mitigation strategies around personal data collection, storage and retention, in the context of clinical trials regardless of whether trials are pharma or medical device related
• Help audience adapt a patient centric approach to clinical trial data and how to build a foundational program for their company if one does not exist

A live Q&A portion with the speaker will follow the presentation.

REGISTRATION FEES & DEADLINES

March10, 2023 — April  4, 2023 Free member | $25 nonmember

Learning Objectives

Audience Learning Level:

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Who Should Attend?

• Regulatory Professionals interested in the complex political and legal landscape around data privacy and protection regulations as applicable to clinical trial data
• Clinical Trial Managers
• IT professionals looking to implement data privacy and protection programs for pharma or medical device clients
• Legal Professionals
• Project managers

Instructors:

Greg Albertyn

Greg Albertyn is a privacy compliance & cyber risk leader in privacy and information risk governance in the life sciences industr who blends global operational, technical, and regulatory expertise to maximize buy-in, efficiency and compliance across the enterprise.Greg regularly advises emerging and late-stage organizations on design and deployment of sustainable data compliance programs and has also held various internal positions including Chief Privacy Officer for a Fortune 500 Life Science organization.

As an IAPP Fellow of Information Privacy Greg brings expertise in privacy policy (CIPP/E & CIPP/US), privacy management (CIPM) and in the audit of information systems and processes (CISA).

Relevant Experience:

• GDPR compliance implementation for a global biotechnology company, including data inventory, subject access, data security, third party management and program governance.
• Global compliance implementation for an oncology therapy manufacturer including G&A functions, R&D, clinical and patient services across US, EMEA and Asia.
• Global privacy compliance audit for a medical device manufacturer including governance structures, breach response preparation, cross-border transfer arrangements and privacy impact assessment procedures.
• Chief Privacy Officer for Fortune 500 Biotechnology Company, building a multi-functional data protection organization covering all aspects of global data privacy compliance.

Cancellations

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org.  RAPS is unable to accept cancellations by phone.

To transfer a registration, email raps@raps.org with the event title, name of the original registrant, and contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: at +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.