PRE-CONFERENCE DAY - TUESDAY, MARCH 25
7.30 Check In
Strategy Track: Ensuring Scalable Compliance
Technical Track: Reducing Risk in Everchanging Environment
Workshop A
Workshop B
8.30 Navigating Global Site Management to Accelerate Rollouts & Ensure Compliance
This workshop will focus on the practicalities of managing global site rollouts, adhering to diverse regulations, and establishing safety programs efficiently in new locations. Attendees will explore the strategies for setting up quickly while ensuring alignment with global policies and meeting local requirements.
- Balancing global standardization with local adaptability
- Tailoring procedures to fit specific country regulations and
cultural practices - Effective methods for ensuring rapid and compliant setup in
new locations - Identifying and retaining talent that understands both global
and local EHS nuances - Tailoring procedures to fit specific country regulations and cultural practices
- Case studies on lessons learned from global training rollouts
William Toneryx, Associate Director, EHS Drug, Discovery & Research, Astellas
Jonah Smith, Safety Specialist, Astellas
8.30 Delving Into Exposure Assessments & Safety Protocols for Novel Compounds to Address Uncertainty in Toxicology
This workshop will focus on the unique challenges of assessing and managing exposure to novel and uncharacterized
compounds in R&D settings. It will delve into exposure banding, safety controls, and the design of adaptable EHS protocols to
handle evolving risks as new data emerges.
- Identifying the risks of handling uncharacterized Active
Pharmaceutical Ingredients (APIs) - The importance of real-time data collection and continuous
monitoring - How to design comprehensive and adaptable protocols
- Understanding exposure banding and its role in toxicology
assessments - Examples from GLP environments, detailing specific banding
methodologies, control strategies and risk assessments
Reinaldo Marin, Associate Director EHS&S,
Pacira
10.30 Morning Break
Workshop C
Workshop D
11.00 Building Scalable & Site-Appropriate EHS Programs to Maximise Success
This workshop will guide participants through developing scalable EHS programs. Emphasis will be placed on strengthening leadership, leveraging benchmarking, evolving KPIs, and engaging employees to foster a safety-first culture across growing organizations.
- Strategies to enhance leadership engagement in driving a safety-first mindset
- The value of benchmarking EHS practices against industry peers
- Managing the scope of responsibilities of CDOs/CMOs
- Shifting from traditional lagging KPIs to leading KPIs that emphasize proactive prevention
- Fostering trust and buy-in from site employees by bottom-up safety ownership
- Collaborating with stakeholders to establish standardized, scalable EHS systems across diverse sites
- Lessons learned from fostering site-specific adaptations while maintaining global safety standards
Monty Stollar, Director HSE External Mfg. Americas & LATAM Affiliates, Elanco
Jay Brown, Associate Director of EHS, Piramal Pharma
Solutions
11.00 Industrial Hygiene in R&D: Assessing Microgram Quantities & Sampling for Potent Compounds to Elevate a Safety Mindset in Labs
This workshop will cover the challenges of keeping both workers and products safe in large-scale manufacturing environments.
It will also explore how to design flexible manufacturing facilities that can adapt to evolving technologies, programs, and regulatory requirements.
- Understanding the difference between biologics and chemicals when handling micro quantities
- How to perform sampling to measure exposure to hazardous chemicals at microgram levels
- Monitoring for OSHA-regulated exposure limits, such as Permissible Exposure Limits and Short-Term Exposure Limits
- An overview of OSHA regulations and guidelines related to chemical exposure and sampling
- Real-world examples of IH sampling and exposure monitoring for potent compounds
Sarah Jones, Senior Manager - Global Environment, Health, Safety & Occupational Hygiene Program Lead, Pfizer
1.00 Networking Lunch
Workshop E
Workshop F
2.00 Scaling HOP Across Global EHS Operations to Drive
Operational Learning
This session will explore the adoption and integration of Human and Organizational Performance principals across global teams. Detailing operational learning tools like: Learning Teams, Proactive Reporting, and Leadership Walk & Talks to drive organizational culture and operational excellence. Attendees will gain new insights into practical strategies for piloting these tools across diverse organizational settings to open proactive mindsets around safety performance, regulatory compliance, and continuous improvement on a global scale.
- Understanding how HOP principles can be applied in large, multi-location organizations
- The role of Learning Teams in fostering collaboration, knowledge sharing, and problem-solving across departments and regions
- Integrating Proactive Reporting systems to foster a reporting culture
- Strategies for building relationships and trust to drive a learning mindset across different regions and cultures
Kirk Smith, Principal, Environmental, Health & Safety
Specialist, Alkermes
1.00 Managing Safety & Flexibility in Manufacturing from GMP Audits, Large-Scale Production, & Future-Proofing Facilities to Minimize Risks to Employees
This workshop will cover the challenges of keeping both workers and products safe in large-scale manufacturing environments.
It will also explore how to design flexible manufacturing facilities that can adapt to evolving technologies, programs, and regulatory requirements.
- Best practices for maintaining worker and product safety when dealing with infectious pathogens and human stem cells
- Risk management strategies for large-scale production environments
Ensuring compliance with evolving regulatory standards across different regions and product types - Addressing biosafety concerns and ensuring containment in large-scale manufacturing processes
- Practical strategies for future-proofing facilities to accommodate evolving regulatory requirements and
technological advancements - Key considerations for scaling viral vector production processes
Chanell Alaniz, Head of Environmental, Health & Safety, Cytovance
4.00 End of Pre-Conference Workshop Day