Day One Agenda
Wednesday, September 11, 2024
8:15 am Coffee & Registration
9:10 am Chair’s Opening Remarks
Mastering Regulatory Compliance: Strategies for Guideline Adherence & Risk Management
9:15 am Roundtable: Ensuring Successful Adoption of FDA Guidelines for Pharmaceutical Companies
Synopsis
- Challenges and consideration in aligning FDA guidelines, geared towards medical devices, with pharmaceutical industry standards
- Strategies for adaptation to meet the specific needs and complexities of the pharmaceutical sector
- Examples that illustrate successful integration from pharmaceutical companies
10:00 am Panel Discussion: Strategic Risk Management – Mapping the Terrain of Regulatory Challenges
Synopsis
- Navigating different levels of risk assessment including system level and requirement level
- What are the best practices for conducting risk assessment and implementing management strategies?
- Hear a range of effective risk management strategies from pharma/biotech/equipment companies
10:30 am Morning Break & Structured Networking
Synopsis
Engage directly with industry peers and IT decision-makers in an environment designed for meaningful conversations and valuable professional connections. This structured format ensures purpose-driven interactions to maximize networking opportunities and gain actionable insights
11:30 am Navigating the Complex Landscape of AI in Life Sciences: Compliance in the Face of Emerging AI Regulations
Synopsis
- Global regulatory activity for AI
- GxP considerations when using AI
- Example use cases in life science
12:00 pm Elastic Stack & GenAI: Your Competitive Edge in a Data-Driven World
Synopsis
- Secure your cloud assets
- Observe your cloud assets
- AI powered search to find anything in everything
Adapting to the Speed of Change: Harmonising Traditional Practices with Rapid Innovations
12:10 pm Bridging the Educational Gap in Technology Adaption
Synopsis
- Identifying the disparity between traditional QA practices and evolving technological landscapes
- Discussing the challenges arising from the lack of familiarity with cloud technologies among QA professionals
- Exploring effective strategies to enhance understanding and implementation of cloud technologies
12:40 pm Private Lunch Hosted by Validated Cloud
Synopsis
1:40 pm Life Science Vendor Risk Scoring: Making Better Vendor Partnership Decisions with Cloud Technology
Synopsis
- Using agency enforcement data to assign relative risk scores to vendors in the global life sciences supply chain
- Helping marketing license holders to ensure their supply chain is GxP-compliant
- Discussing how intelligence solutions can systematically reduce compliance risk and ultimately improve product quality
2:10 pm Audit Blind Spots
Synopsis
- Supported by Validated Cloud
Optimising Cost Efficiencies: Strategic Decision Making for In-house & Outsourced Operations
2:25 pm Analysing The Financial Implications of Cloud Computing to Optimise Costs
Synopsis
- Identifying and quantifying potential hidden costs associated with cloud services
- Selecting license types based on user needs
- Cost differences between support, training, and project services
2:55 pm Determining the Right Approach for Deploying Applications & Workload in the Cloud
Synopsis
- Exploring how standardized configuration and infrastructure as code techniques enable rapid deployment and scalability in cloud environments
- Discussing the role of artificial intelligence (AI) in optimizing cloud operations and reducing deployment times
- Addressing key considerations for maintaining robust security measures and regulatory compliance during cloud deployments