8:15 am Registration & Welcome Coffee
8:50 am Chair’s Opening Remarks
Protecting Data in the Cloud to Meet Regulatory Requirements
9:00 am Data Strategy & Governance – Moving Beyond Data Integrity in Life Sciences
Synopsis
- Understanding the PIC/S guidance on data governance
- Realizing the importance of a “data culture”
- Maintaining compliance from a data perspective
9:30 am Unpacking The Impact of Regulatory Guidance on Cloud Computing
Synopsis
- Exploring how regulatory guidance will impact GxP industry compliance with Cloud service providers (XaaS)
- Ensuring accountability for compliance from sponsors and operating companies that are now required to meet specific expectations when using these services
- Enhancing visibility into IaaS/PaaS/SaaS supplier actions and activities, aligning through risk-based assessments, and defining the intended use are necessary to maintain compliant infrastructure, platforms, and software
10:00 am Continuous Data Privacy and Compliance in Healthcare
Synopsis
- Accelerating compliance through tools and controls inheritance
- The promise and challenges of Generative AI solutions
- Continuous compliance and Audit readiness
- Building trust and transparency with patients and data subjects
10:30 am Morning Break & Networking
11:00 am Panel Discussion: Harnessing Strategies to Maintain Data Integrity & Security in a Life Sciences Cloud Environment
Synopsis
- Approaches to ensure data integrity, security and audit trail to meet regulatory requirements
- Working with cloud providers to apply data integrity requirements necessary for the life sciences industry
- Driving data integrity standards and overcoming the regulatory and business consequences of not protecting patient data
11:45 am Roundtable Discussions
Synopsis
- This interactive session gives you the opportunity to be part of the discussion – to share ideas and learn from your peers. Choose the table most relevant to you and discuss how you are going to prepare for the future of:
12:30 pm Lunch Break & Networking
Implementing Risk Management Approaches for Cloud Compliance
1:30 pm Risk Management Based on Q9 R1 & Beyond
Synopsis
- Regulation objectives and reasons for the revision
- Changes and enhanced expectations
- Beyond Q9 R1, an effective holistic approach
2:00 pm Implementing a Lifecycle of Risk Management Approach to the Cloud
Synopsis
- Best practises to harness a life cycle risk management approach to protect product quality and patient data
- What does a living risk assessment look like when key parts of your IT infrastructure are maintained by cloud service providers
- How does Q9 R1 impact functional and usage assessments around cloud applications
Optimizing Security Strategies to Manage Cyber Threats
2:30 pm Panel Discussion: Leveraging Cybersecurity Tools When Moving to the Cloud in the Life Sciences Industry
Synopsis
- Security issues in the cloud, preventing manipulation, adhering to regulations
- Implications to patient safety
- Addressing cyber security risks, maintaining compliance from a security perspective