8:50 am Chair’s Opening Remarks

  • Daryn Berger Director, Information Technology, Relay Therapeutics

Operational Strategies for Complying with Global Regulations

9:00 am Panel Discussion: Developing a Roadmap to Achieving Global Regulatory Compliance

  • Harry Wolfgang Senior Manager, Technology Regulatory Compliance, Johnson & Johnson
  • Yves Samson CEO, e-Compliance SME, ECA Data Integrity & IT Compliance Group
  • Sanjeev Kumar Sr. Director - Data Integrity and Technology, Vertex Pharmaceuticals
  • Orlando Lopez E-Records Expert,

Synopsis

  • Defining the key differences between international regulations – particularly FDA and EMA
  • Developing a continuous compliance strategy in line with upcoming global updates
  • Communicating different regulatory requirements to different team members

9:45 am Leveraging Technology for Regulatory Intelligence and Managing Standards/Policies When Regulations Change

  • Harry Wolfgang Senior Manager, Technology Regulatory Compliance, Johnson & Johnson

Synopsis

  • Current Challenges in Regulatory Intelligence (RI) and Standards Management
  • How can we leverage technology to create opportunities
  • Methods to effectively communicate and educate when regulations change

10:15 am Planning Data Transfer While Remaining Compliant with FDA and European Regulations

Synopsis

• Moving data from one cloud provider to another
• Migrating existing data into the cloud
• Removing outdated computer systems

10:45 am
Morning Coffee Break & Structured Networking Session

Effective Strategies for Long-Term Vendor Management

11:45 am Automating GxP Workflows and Maintaining Continuous Compliance

  • Vishal Sharma Vice President of Digital Trust and Transformation, USDM Life Sciences

Synopsis

• Every day, life sciences companies must deal with various events having regulatory implications and find the most efficient way to resolve them. USDM will discuss solutions for simplifying and automating regulated workflows and processes to drive greater efficiency and insight for better business decisions across your organization while maintaining compliance.
• Automating and scaling your regulated business processes
• Maintaining continuous cloud compliance
• Gaining greater insight into your product lifecycle to minimize costly recalls or undetected systemic issues

12:15 pm Defining Standards and Ownership of Data to be Compliant with FDA Regulations in an Automated World

Synopsis

• Leveraging regulatory, legal and internal policy considerations
• Establishing sustainable data access and rights for customers, vendors
• Certifying business continuity planning

12:45 pm
Lunch Break & Networking

1:45 pm Engaging with GxP Providers: A Client Perspective

  • Vishal Goyal Director, IT Business Partnering R&D, Clinical, CMC, Manufacturing, TCR2 Therapeutics

Synopsis

  • Recognizing roles and responsibilities of vendors and clients
  • Understanding who validates each service
  • Outlining post go-live expectations

2:15 pm Understanding the Business Models of Vendors

  • Chris Clayton Director of Information Technology, INCOG BioPharma

Synopsis

• Outlining vendor audits that ensure security of data and GxP compliance
• Attaining satisfactory documentation for compliance
• Planning for the future with a vendor

2:45 pm Fireside Chat: Creating Strong Mutually-Beneficial Working Relationship with Vendors

Synopsis

• Factoring transparency into long-term relationship building
• Creating trust between vendors and customers
• Developing strategies to ensure problems are addressed and questions answered in real time

3:30 pm
Afternoon Coffee Break & Networking

4:00 pm Conducting Appropriate Site Inspections & Reviews

  • Yves Samson CEO, e-Compliance SME, ECA Data Integrity & IT Compliance Group

Synopsis

• Understanding vendor quality systems and objectives of a compliance audits
• Outlining the evidence required for an audit
• Creating tests to achieve the desired results

4:30 pm Ensuring E-Records Integrity of Cloud Services

Synopsis

• Defining NIST 800-57 in regards to data integrity
• Identifying data integrity controls to be considered
• Integrating e-records into cloud services

5:00 pm Creating Mitigations for the Backup and Recovery of Data

  • Sanjeev Kumar Sr. Director - Data Integrity and Technology, Vertex Pharmaceuticals

Synopsis

This interactive session will give you the opportunity to dive into the conversation
with your fellow colleagues to discuss, debate and get inspiration on how to
approach:
• Creating a backup and recovery plan
• Understanding first steps when data is lost
• Utilizing different recovery strategies

5:30 pm Chair’s Closing Remarks

  • Daryn Berger Director, Information Technology, Relay Therapeutics