2nd Annual Clinical Risk Management For Emerging Companies, October 24, 2023, Virtual Event, Build an Effective Clinical Risk Management Strategy Using Available Resources to Achieve a Confident State of GCP Inspection Readiness
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Interested in becoming part of the 2023 Clinical Risk Management for Emerging Companies speaking faculty?

Email Kristen Hunter at Kristen@momentumevents.com

AGENDA

12:30pm PT - Registration for Workshop Participants
1:00pm PT - WORKSHOP: RISK MANAGEMENT PLAN
Develop a Plan to Identify, Manage and Mitigate Identified Critical Risk Areas

Leslie Sam, President, LESLIE SAM AND ASSOCIATES, LLC
Anne Marie Inglis, Executive Director, Clinical Operations, AFFINIVAX

  • Walk through a sample risk management plan
  • Discuss how to leverage scoring to articulate risks
  • Outline how to track and trend critical data to manage risks
  • Prioritize outputs from the plan to optimize risk management
4:30pm PT - Workshop Day Concludes
8:00am PT - Registration and Breakfast
8:30am PT - CHAIRPERSON’S WELCOME AND INDUSTRY UPDATE
Sharon Reinhard, Vice President, Global Quality, AVROBIO

Virtual
Access

9:00am PT - ICH E6 R2 AND R3
Breakdown the Elements of ICH E6 (R2) and ICH E6 (R3) That Relate to Clinical Risk Management

Michelle Webb, Vice President, WCG AVOCA QUALITY CONSORTIUM

  • Outline the elements of ICH E6 (R2 and R3) that pertain to clinical risk management
    o Identify the overriding principles of Quality by Design
    o Define critical to quality factors and evaluate their purpose
    o Embrace a quality culture
  • Evaluate what is required and what is recommended and how regulatory agencies have responded
    o Are companies currently being inspected to ensure compliance with these elements?

Virtual
Access

9:30am PT - EXPERT PANEL: TRANSLATE REGULATIONS INTO PRACTICE
Understand How the Principles of ICH E6 R2 and R3 Are Being Applied to Clinical Risk Management

Moderator
Michelle Webb, Vice President, WCG AVOCA QUALITY CONSORTIUM

Panelists
Sharon Reinhard, Vice President, Global Quality, AVROBIO
Additional Panelists TBD

  • Hear case study examples of how companies are applying risk management principles from R2 and R3
  • Understand what a quality culture looks like at a small company and learned practices for building and maintaining it
  • Outline how risk-based approaches are being executed and how to prioritize implementation
  • Share level of inspection readiness and what ongoing actions are being taken to prepare

Virtual
Access

10:30am PT - Networking and Refreshment Break
11:00am PT - RISK MANAGEMENT FRAMEWORK
Build an Effective Risk Management Framework that Drives Compliance and Inspection Readiness

Leslie Sam, President, LESLIE SAM AND ASSOCIATES, LLC

  • Describe a Risk Management Framework
  • Outline a Methodology for Creating a Risk Management Framework
  • Discuss the responsibilities of Risk Management governance

Virtual
Access

11:30am PT - INTERACTIVE SESSION: RISK TECHNOLOGIES
Navigate What Tools and Technologies Enable Appropriate Clinical Risk Management Practices at Small Companies

  • Discuss how different companies are using tools and technologies to manage clinical risk
  • Clarify how clinical risk tools and technologies fit into the larger picture of all the clinical technologies
  • Prioritize the necessity of tools and what’s available now vs. what comes at a cost
  • Outline best practices and lessons learned when leveraging tools and technologies to manage clinical risk

Virtual
Access

12:30pm PT - Lunch for In-Person Experience
1:30pm PT - OUTSOURCING RISKS
Discuss the Varying Risks Introduced When Outsourcing to Multiple Vendors and How to Prioritize Oversight

Sarah Silvers, MS, RQAP-GCP, Former Senior Director, GCP Quality Assurance, SANBIO

  • Determine and prioritize the risks associated with outsourcing and how they are impacted when more vendors are introduced
  • Define sponsor oversight responsibilities and build a vendor oversight plan that addresses identified prioritized risks
  • Develop vendor qualification criteria to mitigate outsourcing risks
2:00pm PT - EXPERT PANEL: RELATIONSHIP MANAGEMENT
Collaborate with Clinical Partners to Ensure Clinical Risk Tolerances and Goals are Aligned

Moderator
Sarah Silvers, MS, RQAP-GCP, Former Senior Director, GCP Quality Assurance, SANBIO

Panelists
Allison Duran, Associate Director, Clinical Oversight and Optimization, SANGAMO THERAPEUTICS
Michele Weitz, Executive Director, Clinical Standards and Innovation, CLOVIS ONCOLOGY

  • Examine how different companies approach collaboration with and oversight of their vendor partners
  • Identify the most important questions to ask and/or metrics to collect when selecting vendors
  • Evaluate ways to gain insight into the quality culture of partners and what to do when it does not align with yours
  • Discuss strategies for effective communication and transparency among all stakeholders
3:00pm PT - Networking and Refreshment Break
3:30pm PT - ROUNDTABLE DISCUSSIONS
Each conference participant selects one topic from the following list to discuss in an intimate setting. You’ll be asked for your topic selections via email a few weeks out from the conference and will have the opportunity to also sign up onsite.

  1. Study Drug Supply Risk: Discuss Best Practices for Effectively Managing Risks Related to Study Drug Supply
  2. Safety Monitoring and Reporting: Leverage Safety and Quality Indicators to Determine when and how to Report Safety Issues
  3. Risk-Based Monitoring: Evaluate How Different Companies are Executing Risk-Based Monitoring in a Small Company Setting
  4. Quality Culture Assessment: Share Strategies for Assessing the Health of your Company’s Culture of Quality
  5. Quality Culture Implementation: Outline Effective Approaches for Initiating a Culture of Quality at a Small Company
4:15pm PT - Networking Reception
8:45am PT - Registration and Continental Breakfast
9:15am PT - CHAIR WELCOME
Sharon Reinhard, Vice President, Global Quality, AVROBIO
9:30am PT - STUDY DRUG AND PV RISKS
Discuss Challenges and Solutions for Managing Study Drug and Pharmacovigilance (PV) Risks in a Small Company / Outsourcing Environment

Sharon Reinhard, Vice President, Global Quality, AVROBIO

  • Describe the kinds of risks associated with study drug design / management and PV activities that may exist in small companies
  • Discuss strategies for managing study drug and safety risks when there is no clear established role or department
  • Share recommendations for how to review and document PV activities in a small company or when outsourced
  • Evaluate options for identifying and managing risks associated with management of study drug and PV activities
10:00am PT - ISSUE IDENTIFICATION AND COMMUNICATION
Determine What Processes Must Be in Place to Effectively Communicate and Manage Any Identified Issues

Michele Weitz, Executive Director, Clinical Standards and Innovation, CLOVIS ONCOLOGY

  • Gain confidence that partners will effectively communicate any issues with a detailed escalation plan
  • Foster a culture of transparency and open communication so partners understand the importance of reporting issues early
  • Discuss what types of issues require sponsor notification and outline the proper flow of communication
10:30am PT - Networking and Refreshment Break
11:00am PT - EXPERT PANEL: ESCALATION PLANS AND CLINICAL CAPAs
Discuss Real-Life Examples of What Should and Should Not Happen with Issue Escalation and Corrective and Preventive Actions (CAPAs)

Moderator
Michele Weitz, Executive Director, Clinical Standards and Innovation, CLOVIS ONCOLOGY

Panelists
Karen Harvey, Senior Director, WCG AVOCA QUALITY CONSORTIUM
Marci Macpherson, Executive Director, Quality Assurance and Compliance, IONIS PHARMACEUTICALS
Anne Marie Inglis, Executive Director, Clinical Operations, AFFINIVAX

  • Share measurable approaches for mitigation and remediation when a risk is realized
  • Learn best practices from experiences where the communication of issues did not occur in a timely or effective manner
  • Outline the critical elements of a clinical CAPA and how to oversee the proper execution and check effectiveness
12:00pm PT - Lunch
1:00pm PT - INSPECTION RISK
Assess Inspection Risks to Optimize Resource Allocation and Readiness Efforts

Marci Macpherson, Executive Director, Quality Assurance and Compliance, IONIS PHARMACEUTICALS

  • Evaluate recent inspection findings to determine areas of focus
  • Conduct assessments to determine the risk of upcoming inspections
  • Assess inspection preparation among all stakeholders focusing on areas of the highest impact
  • Discuss best practices for staying current on regulatory developments that impact inspection risk and readiness processes

Virtual
Access

1:30pm PT - EXPERT PANEL: GCP INSPECTION BUZZ
Hear Recent GCP Inspection Experiences and Communication with Varying Regulatory Authorities

Panelists
Marci Macpherson, Executive Director, Quality Assurance and Compliance, IONIS PHARMACEUTICALS
Sarah Silvers, MS, RQAP-GCP, Former Senior Director, GCP Quality Assurance, SANBIO

  • Learn the latest inspection gossip and what this might mean for your inspection readiness practices
  • Evaluate challenges with recent inspections due to COVID
  • Discuss experiences with hybrid and remote inspections

Virtual
Access

2:30pm PT - CHAIRPERSON’S CLOSING REMARKS
Sharon Reinhard, Vice President, Global Quality, AVROBIO

Virtual
Access

2:45pm PT - Close of Conference