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3rd Clinical Quality Oversight
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Tuesday, May 21
 

8:00am EDT

Registration and Continental Breakfast for Workshop Participants
Tuesday May 21, 2024 8:00am - 8:30am EDT
  IN-PERSON Experience ONLY

8:30am EDT

AM WORKSHOP: CRITICAL TO QUALITY FACTORS
Outline a Basic Approach for Identifying the Critical To Quality Factors (CTQs) of the Study and Understand How the CTQs Then Drive Risk-Proportionate Decisions 
  • Review the regulatory changes driving this increased focus on quality
  • Walk through practical ways to understand and evaluate critical to quality factors using case study examples
  • Learn triage questions to easily determine if something is critical to quality
  • Explore ways to evaluate critical to quality factors by looking at most likely failure modes, ways to improve quality, and understand effectiveness
  • Examine the relevance of CTQs for downstream clinical actions, including partner selection and qualification, executing oversight, and auditing  
Speakers
avatar for Leslie Sam

Leslie Sam

President, Leslie Sam and Associates, LLC
Accomplished, results-driven, passionate CLINICAL RESEARCH AND QUALITY PROFESSIONAL with over 20+ years of transferable technical and leadership skills [business acumen, interpersonal skills (verbal and written), Six Sigma Black Belt certification (CSSBB), Quality Improvement Associate... Read More →
avatar for Michael Torok, Ph.D.

Michael Torok, Ph.D.

Vice President, Global Head of Quality Assurance Programs, GENENTECH, a Member of the ROCHE Group
Accelerating therapeutics to patients through innovative operations and quality assurance practices. Improving cross-functional Risk Based Quality Management practices through a robust, organizational Quality Culture with a focus on impactful quality outcomes. Clinical enterprise... Read More →

Tuesday May 21, 2024 8:30am - 12:00pm EDT
  IN-PERSON Experience ONLY, Interactive Workshop

12:00pm EDT

Lunch for Workshop Participants
Tuesday May 21, 2024 12:00pm - 1:00pm EDT
  IN-PERSON Experience ONLY, Networking

1:00pm EDT

PM WORKSHOP: BUILD AN OVERSIGHT MODEL
Design an Effective Clinical Oversight Governance Model from the Study’s Critical to Quality Factors 
  • Understand how clinical quality governance models have changed and why what used to work no longer does
  • Define the purpose of an oversight plan/model for all involved stakeholders
  • Return to basics and identify the core fundamentals of an effective governance model and how to integrate the study’s critical to quality factors
  • Examine how the oversight plan relates to other trial documentation such as the quality agreement and TMF
  • Discuss effective ways to tie performance to big picture impact
  • Incorporate ongoing assessment to ensure continued alignment and compliance with governance model
Speakers
avatar for Cheryl McCarthy, RQAP-GCP, CQA, CMDA

Cheryl McCarthy, RQAP-GCP, CQA, CMDA

Principal, ANCHOR QA, LLC
Quality Assurance professional providing a full range of related consulting: Corporate QA strategy and strategic QMS management | Virtual/interim/fractional QA services | Internal and external audits, and inspection readiness activities. SQA Board of Directors (2022-2024 term), currently... Read More →

Tuesday May 21, 2024 1:00pm - 4:30pm EDT
  IN-PERSON Experience ONLY, Interactive Workshop
 
Wednesday, May 22
 

8:00am EDT

Registration and Continental Breakfast
Wednesday May 22, 2024 8:00am - 8:30am EDT
  IN-PERSON Experience ONLY, Networking

8:30am EDT

CO-CHAIR'S WELCOME AND INDUSTRY UPDATE
Speakers
avatar for Michael Torok, Ph.D.

Michael Torok, Ph.D.

Vice President, Global Head of Quality Assurance Programs, GENENTECH, a Member of the ROCHE Group
Accelerating therapeutics to patients through innovative operations and quality assurance practices. Improving cross-functional Risk Based Quality Management practices through a robust, organizational Quality Culture with a focus on impactful quality outcomes. Clinical enterprise... Read More →
avatar for Sharon Reinhard

Sharon Reinhard

Clinical Quality Expert, Independent Consultant
Experienced pharmaceutical executive with 25 years of industry experience, including roots in academia. Most recently Head of Commercial and R&D Quality at AVEO Oncology.  Prior to that, Vice President/ Head of Quality at AVROBIO, a gene therapy company focused on lysosomal storage... Read More →


Wednesday May 22, 2024 8:30am - 9:00am EDT
  Included in VIRTUAL Experience

9:00am EDT

R3 AND SPONSOR OVERSIGHT
Outline the Aspects of ICH E6 (R3) that Impact Sponsor Oversight to Define and Prioritize Your Path to Compliance 
Speakers
avatar for Dawn Niccum

Dawn Niccum

Executive Vice President, Quality Assurance & Compliance, inSeption group
With over 25 years of Clinical Operations and Quality Assurance pharmaceutical experience, Dawn provides clients a unique perspective of efficiency, speed, and compliance. She is an experienced leader in clinical quality and compliance, SOP development, computer system validation... Read More →


Wednesday May 22, 2024 9:00am - 9:30am EDT
  Included in VIRTUAL Experience

9:30am EDT

SENIOR LEADERS PANEL: DRIVING CULTURAL CHANGE
Learn Strategies for Championing Cultural Change and Measuring the Impact on RBQM Operations
  • What does a culture of quality mean to you and your company?  
  • Discuss approaches for teaching critical thinking while maintaining psychological safety for diversity of thought 
  • Share strategies for quantifying change management to be able to measure the progress of the cultural shift 
  • Correlate risk-based quality management (RBQM) operation improvements to cultural change 

Speakers
avatar for Misha Abraham

Misha Abraham

Head of Clinical Risk Management Strategy, Innovative Medicine & MedTech, Johnson & Johnson
avatar for Paul Houri

Paul Houri

Quality Vice President, Research & Development, Bristol-Myers Squibb
Dynamic and strategic Quality and Compliance leader with 25 years of GXP experience spanning Pharmaceuticals, Medical Devices, and Consumer products. Passionate about innovating quality for the future, building high-performance teams, and individual talent development. Proven success... Read More →
avatar for Kerstin Koenig

Kerstin Koenig

Vice President, Global Quality Assurance, GSK
I am passionate about driving a better outcome for patients and customers building a culture of quality that engages and empowers cross-functional teams to do their best at work.My career spans nearly 25 years in biopharmaceutical industry with me being an ambassador for quality as... Read More →


Wednesday May 22, 2024 9:30am - 10:15am EDT
  Included in VIRTUAL Experience

10:15am EDT

Audience Comments and Q&A For Previous Speakers
Dedicated time for taking questions and comments from BOTH the in-person and virtual audiences.  

Wednesday May 22, 2024 10:15am - 10:30am EDT
  Included in VIRTUAL Experience

10:30am EDT

Networking and Refreshment Break
Wednesday May 22, 2024 10:30am - 11:00am EDT
  IN-PERSON Experience ONLY

11:00am EDT

FDA KEYNOTE: DON’T INSPECT IN QUALITY, BUILD IT IN
Understand FDA’s Push to Build Quality into the Clinical Trial Process through Proactive Compliance, Instead of Leveraging Inspections to Trigger Quality Measures 
FDA (invited)
  • Understand what it means to build in quality
  • Examine recent  inspection finding trends and how they relate to quality by design
  • Discuss proactive actions organizations can take to showcase risk management practices, to expedite or even eliminate the need for an inspection
  • Extended Q&A so bring your burning questions

Wednesday May 22, 2024 11:00am - 11:45am EDT
  Included in VIRTUAL Experience

11:45am EDT

Audience Comments and Q&A
Dedicated time to hear comments and take questions from BOTH the in-person and virtual audiences.

Wednesday May 22, 2024 11:45am - 12:00pm EDT
  Included in VIRTUAL Experience

12:00pm EDT

FOR VIRTUAL ATTENDEES ONLY - BOOST YOUR NETWORK
Interactive Discussions with Fellow Virtual Participants on Clinical Quality Oversight Best Practices - Guided Conversations Prompted by Videos 
  • Engage with fellow virtual participants to problem solve and collaborate on topics to oversight
  • Discuss the main themes of the conference and how to apply at your company
  • Share challenges and successes with like-minded peers and leave with new and meaningful connections
Wednesday May 22, 2024 12:00pm - 12:55pm EDT
  Included in VIRTUAL Experience

12:00pm EDT

Lunch for In-Person Participants
Wednesday May 22, 2024 12:00pm - 1:00pm EDT
  IN-PERSON Experience ONLY

1:00pm EDT

INTERACTIVE CROWD-SOURCE: FINDING THE RIGHT PARTNER
Share Tools and Best Practices from Your Experiences that Optimize the Identification, Qualification, and Selection of Clinical Partners
  • How do you find vendors?  Where do you look for specific types of vendors?
  • What questions or processes for qualifying your partners have proven effective? 
  • How do you gain insight into the quality culture of potential partners and determine if it aligns with yours?
  • What kinds of ongoing performance assessments do you conduct?  
  • Share what you’ve learned from nightmare partner situations and how they could have been prevented
Wednesday May 22, 2024 1:00pm - 1:45pm EDT
  IN-PERSON Experience ONLY

1:45pm EDT

OVERSIGHT OF GCP RISK
Leverage Organizational Oversight of GCP Risk to Ensure Compliance
  • Define organizational oversight of risk from “bootstrap” level to a leading edge perspective
  • Identify the roles, processes, and data that are required 
  • Examine the cultural aspects that should be in place to ensure success 
  • Discuss recent challenges to oversight of risk and how they were overcome 
Speakers
avatar for Jonathan Rowe, Ph.D.

Jonathan Rowe, Ph.D.

Principal - Head of R&D Quality, Operations, and Risk Management, ZS
Also known as the Godfather of Clinical Quality Risk Management, Jonathan Rowe is the lead singer for a heavy metal cover band that features his son on bass, officially making him "The Coolest Dad" . He’s also spent 25 years of experience supporting pharmaceutical companies in the... Read More →

Wednesday May 22, 2024 1:45pm - 2:30pm EDT
  IN-PERSON Experience ONLY

2:30pm EDT

ASSESS VENDOR RISK
Apply A Risk-Based Methodology to Vendor Qualification and Ongoing Performance Assessments to Optimize Resources and Ensure Compliance
  • Discuss a risk-based approach to categorizing active vendors for initial and ongoing qualification 
  • Factoring in the study’s CTQs to develop a risk-based and scalable vendor qualification process 
  • Identify risk-control parameters to help mitigate delays in the qualification process and beyond
  • Discuss effective strategies for conducting continuous risk assessments of vendor performance 
  • Share how to handle high-risk observations that can impact future selection and qualification
Speakers
avatar for Sharon Reinhard

Sharon Reinhard

Clinical Quality Expert, Independent Consultant
Experienced pharmaceutical executive with 25 years of industry experience, including roots in academia. Most recently Head of Commercial and R&D Quality at AVEO Oncology.  Prior to that, Vice President/ Head of Quality at AVROBIO, a gene therapy company focused on lysosomal storage... Read More →

Wednesday May 22, 2024 2:30pm - 3:00pm EDT
  IN-PERSON Experience ONLY

3:00pm EDT

Networking and Refreshment Break
Wednesday May 22, 2024 3:00pm - 3:30pm EDT
  IN-PERSON Experience ONLY

3:30pm EDT

EXPERT PANEL: QA COMPETENCY
Discuss the Core Competencies of an Effective Clinical Quality Professional Who Can Identify Quality Issues that Matter 
  • Understand what skills/qualifications can identify critical thinkers
  • Discuss any processes put in place to help screen for effective quality professionals
  • Share any advice for a rising quality professional to gain the skills necessary?
  • Assess the impact/disruption of AI/ML on the clinical quality professional
Speakers
avatar for Priya Chaturvedi, Ph.D.

Priya Chaturvedi, Ph.D.

Vice President, Head of Global Clinical Quality, EISAI, INC.
Priya Chaturvedi is Vice President, Head of Global Clinical Quality at Eisai inc. She has responsibility for Global Clinical Quality Assurance (CQA), Global Clinical Quality Management and Global Process and Standards. She joined Eisai in 2019. Prior to that, she was Executive Director... Read More →
avatar for Leslie Sam

Leslie Sam

President, Leslie Sam and Associates, LLC
Accomplished, results-driven, passionate CLINICAL RESEARCH AND QUALITY PROFESSIONAL with over 20+ years of transferable technical and leadership skills [business acumen, interpersonal skills (verbal and written), Six Sigma Black Belt certification (CSSBB), Quality Improvement Associate... Read More →
avatar for Michael Torok, Ph.D.

Michael Torok, Ph.D.

Vice President, Global Head of Quality Assurance Programs, GENENTECH, a Member of the ROCHE Group
Accelerating therapeutics to patients through innovative operations and quality assurance practices. Improving cross-functional Risk Based Quality Management practices through a robust, organizational Quality Culture with a focus on impactful quality outcomes. Clinical enterprise... Read More →
avatar for Kerstin Koenig

Kerstin Koenig

Vice President, Global Quality Assurance, GSK
I am passionate about driving a better outcome for patients and customers building a culture of quality that engages and empowers cross-functional teams to do their best at work.My career spans nearly 25 years in biopharmaceutical industry with me being an ambassador for quality as... Read More →
avatar for Jolie Weintraub

Jolie Weintraub

AVP, Quality Assurance, Merck & Co.
Jolie Weintraub is AVP of Clinical Quality in MRL Quality Assurance, She is responsible for setting andoverseeing QA activities across all therapeutic area clinical programs from early FIH studies through latestage development. Additionally, within this role, she collaboratively works... Read More →

Wednesday May 22, 2024 3:30pm - 4:15pm EDT
  IN-PERSON Experience ONLY

4:15pm EDT

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 preferences via email a week or so out from the conference and sign-up sheets for the remaining slots will be available onsite.
  • WHAT MAKES A QUALITY CULTURE?  Discuss the Cultural Tenets Needed to Embrace Transparency and Fuel a Quality-First Mindset
  • GLOBAL QUALITY CULTURE: Share Experiences on Transforming Quality Culture in a Global Organization where Cultural Norms are Quite Different
  • EFFECTIVENESS CHECKS:  Manage Issue Resolution to Mitigate Risk by Preventing Future Occurrences
  • QUALITY BY DESIGN: Understand the Concept of Quality By Design as it Relates to Vendor Oversight and how Build Quality into the Partnership to Ensure Compliance
  • CLINICAL DATA INTEGRITY: Share Common Data Integrity Challenges and Oversight Strategies to Mitigate Them  
  • STORYBOARDS: Understand How Companies are Using Storyboards to Document Oversight
  • OVERSIGHT AT SMALL COMPANIES:  Engage with Other Small Companies on How to Execute Effective Oversight with Limited Resources
  • CHANGE MANAGEMENT: Share Best Practices for Handling and Managing Change without Impacting Clinical Quality Oversight
  • OVERSIGHT RESPONSIBILITY AND DOCUMENTATION:  Discuss Varying Approaches for Assigning who Owns, Manages and Documents the Oversight Process to Evaluate the Best Fit for Your Company
  • QUALITY AGREEMENTS: Discuss the Utility of a Quality Agreement and How it Relates to Other Documentation
  • MOCK INSPECTIONS:  Evaluate Varying Approaches for Leveraging Mock Inspections as an Oversight Tool

Wednesday May 22, 2024 4:15pm - 5:00pm EDT
  IN-PERSON Experience ONLY

5:00pm EDT

Booze and Schmooze/ Mock and Talk Networking Reception
Clinical quality and operations peeps know how to have fun after a productive day of in-person engagement.  Let your hair down, grab a beer or soda, nosh on some appetizers, and then let the inspection horror stories roll out........    
Wednesday May 22, 2024 5:00pm - 6:00pm EDT
  IN-PERSON Experience ONLY
 
Thursday, May 23
 

8:30am EDT

Registration and Continental Breakfast
Thursday May 23, 2024 8:30am - 9:00am EDT
  IN-PERSON Experience ONLY

9:00am EDT

CO-CHAIRS' HIGHLIGHTS FROM PREVIOUS DAY
Speakers
avatar for Michael Torok, Ph.D.

Michael Torok, Ph.D.

Vice President, Global Head of Quality Assurance Programs, GENENTECH, a Member of the ROCHE Group
Accelerating therapeutics to patients through innovative operations and quality assurance practices. Improving cross-functional Risk Based Quality Management practices through a robust, organizational Quality Culture with a focus on impactful quality outcomes. Clinical enterprise... Read More →
avatar for Sharon Reinhard

Sharon Reinhard

Clinical Quality Expert, Independent Consultant
Experienced pharmaceutical executive with 25 years of industry experience, including roots in academia. Most recently Head of Commercial and R&D Quality at AVEO Oncology.  Prior to that, Vice President/ Head of Quality at AVROBIO, a gene therapy company focused on lysosomal storage... Read More →

Thursday May 23, 2024 9:00am - 9:15am EDT
  IN-PERSON Experience ONLY

9:15am EDT

INTERACTIVE CROWD-SOURCE: GLOBAL OVERSIGHT CHALLENGES
What Unexpected Challenges Have You Encountered When Executing Clinical Quality Oversight on a Global Scale and How Could You Have Better Prepared?
  • Understand which countries people are working in and where is proving to be the most challenging with regards to clinical quality oversight
  • Share those horror stories and let’s learn from them, so as not to repeat
  • Bring your best practices, challenges, and questions when conducting global studies and let’s leverage the brain power of this impressive crowd!  
Thursday May 23, 2024 9:15am - 9:45am EDT
  IN-PERSON Experience ONLY

9:45am EDT

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 preferences via email a week or so out from the conference and sign-up sheets for the remaining slots will be available onsite.
  • WHAT MAKES A QUALITY CULTURE?  Discuss the Cultural Tenets Needed to Embrace Transparency and Fuel a Quality-First Mindset
  • GLOBAL QUALITY CULTURE: Share Experiences on Transforming Quality Culture in a Global Organization where Cultural Norms are Quite Different
  • EFFECTIVENESS CHECKS:  Manage Issue Resolution to Mitigate Risk by Preventing Future Occurrences
  • QUALITY BY DESIGN: Understand the Concept of Quality By Design as it Relates to Vendor Oversight and how Build Quality into the Partnership to Ensure Compliance
  • CLINICAL DATA INTEGRITY: Share Common Data Integrity Challenges and Oversight Strategies to Mitigate Them  
  • STORYBOARDS: Understand How Companies are Using Storyboards to Document Oversight
  • OVERSIGHT AT SMALL COMPANIES:  Engage with Other Small Companies on How to Execute Effective Oversight with Limited Resources
  • CHANGE MANAGEMENT: Share Best Practices for Handling and Managing Change without Impacting Clinical Quality Oversight
  • OVERSIGHT RESPONSIBILITY AND DOCUMENTATION:  Discuss Varying Approaches for Assigning who Owns, Manages and Documents the Oversight Process to Evaluate the Best Fit for Your Company
  • QUALITY AGREEMENTS: Discuss the Utility of a Quality Agreement and How it Relates to Other Documentation
  • MOCK INSPECTIONS:  Evaluate Varying Approaches for Leveraging Mock Inspections as an Oversight Tool

Thursday May 23, 2024 9:45am - 10:30am EDT
  IN-PERSON Experience ONLY

10:30am EDT

Networking and Refreshment Break
Thursday May 23, 2024 10:30am - 11:00am EDT
  IN-PERSON Experience ONLY

11:00am EDT

MINI CASE STUDIES: ANALYTICS AND OVERSIGHT
Understand How Analytics are Currently Being Utilized at Companies of Varying Sizes to Optimize Oversight of Clinical Sites and Partners 
  • Outline where each company is on their clinical data analytics journey and how they got there 
  • Discuss what data is needed to drive specific metrics and outcomes to optimize oversight 
  • Breakdown exactly how data analytics are currently being leveraged and using what data 
  • Share how analytics are being translated into actions to mitigate risk and optimize oversight 
Speakers
avatar for Niloy N. Shah

Niloy N. Shah

Head of Global Quality, HUTCHMED INTERNATIONAL
Niloy N Shah currently serves as the Head of Global Quality at HUTCHMED International. Niloy comes from a long tenure in the start-up and small biopharmaceutical space with leadership roles in various organizations such as Auro Vaccines, Verdem Health LLC, and NextGen Healthcare Solutions... Read More →

Thursday May 23, 2024 11:00am - 12:00pm EDT
  IN-PERSON Experience ONLY

12:00pm EDT

Lunch
Thursday May 23, 2024 12:00pm - 1:00pm EDT
  IN-PERSON Experience ONLY

1:00pm EDT

SMALL COMPANY CASE STUDY: A RETROSPECTIVE VIEW OF A FAILED PARTNERSHIP
Learn from a Small Company's Experience Uncovering Multiple Misconduct Issues at the CRO and Site Levels and what Actions Could Prevent a Similar Situation  
  • Establish case study background and the heavy reliance on the CRO/CRA 
  • Discuss how issues were uncovered and what could have been done differently 
  • Outline the decision to bring monitoring in-house and what that entailed 
  • Evaluate the outcome, impact to trial integrity, and what actions/processes are now in place as a result 
Speakers
avatar for Elizabeth Polvent

Elizabeth Polvent

Senior Director, Clinical Operations, ARTHROSI THERAPEUTICS, INC.
In the dynamic realm of pharmaceutical R&D, where every decision counts and every action can have significant downstream consequences, Elizabeth’s extensive 20+ year career is marked by a relentless pursuit of high-quality data and a steadfast dedication to ethical practices. From... Read More →
avatar for Pamela Mundell

Pamela Mundell

Clinical Trial Manager, ARTHROSI THERAPEUTICS, INC.
Pamela Mundell is a Clinical Trial Manager specializing in Phase II and Phase III trials in the pharmaceutical and biotechnology industry.    Leveraging her understanding of global regulatory requirements and best GCP practice,  she oversees the planning, execution and monitoring... Read More →


Thursday May 23, 2024 1:00pm - 1:30pm EDT
  Included in VIRTUAL Experience

1:30pm EDT

CASE STUDY: TRADITIONAL TO RISK-BASED
Examine a Mid-Study Shift from Traditional Monitoring to a Holistic Risk-Based Approach and the Hidden Cultural Barriers to Compliance that it Uncovered
  • Detail the background for a Decentralized Malaria trial in Mozambique and Kenya
  • Discuss observed quality concerns and what actions needed to take place
  • Identify the elements of oversight that were missing and required to result in usable data
  • Outline cultural biases unique to certain communities impacting the quality of the data
  • Redesign the trial applying a holistic and adaptable risk-based approach to monitoring that resulted in proactive issue identification 


Speakers
avatar for Leslie Sam

Leslie Sam

President, Leslie Sam and Associates, LLC
Accomplished, results-driven, passionate CLINICAL RESEARCH AND QUALITY PROFESSIONAL with over 20+ years of transferable technical and leadership skills [business acumen, interpersonal skills (verbal and written), Six Sigma Black Belt certification (CSSBB), Quality Improvement Associate... Read More →
avatar for Lisa Collins

Lisa Collins

Clinical Operations Expert in Nigeria
A dedicated Biotech and Pharmaceutical Leader with over 20 years experience in Clinical Operations and Drug Development Program Management. Managing multi-disciplinary globally distributed teams across North and South America, EMEA, South African and APAC regions, through multi-complex... Read More →


Thursday May 23, 2024 1:30pm - 2:00pm EDT
  Included in VIRTUAL Experience

2:00pm EDT

Audience Comments and Q&A for Previous Speakers

Thursday May 23, 2024 2:00pm - 2:15pm EDT
  Included in VIRTUAL Experience

2:15pm EDT

CONCLUDING PANEL: GCP INSPECTION GOSSIP
Fine Tune your Quality Oversight Plan with Insight from Recent GCP Inspection Experiences and Communication with Varying Regulatory Authorities
  • Learn the latest inspection gossip and what this might mean for your oversight practices
  • Identify trends from recent experiences to determine the regulatory focus of different agencies
Speakers
avatar for Sharon Reinhard

Sharon Reinhard

Clinical Quality Expert, Independent Consultant
Experienced pharmaceutical executive with 25 years of industry experience, including roots in academia. Most recently Head of Commercial and R&D Quality at AVEO Oncology.  Prior to that, Vice President/ Head of Quality at AVROBIO, a gene therapy company focused on lysosomal storage... Read More →


Thursday May 23, 2024 2:15pm - 3:00pm EDT
  Included in VIRTUAL Experience

3:00pm EDT

CO-CHAIR'S CLOSING REMARKS
See you next year! 
Speakers
avatar for Michael Torok, Ph.D.

Michael Torok, Ph.D.

Vice President, Global Head of Quality Assurance Programs, GENENTECH, a Member of the ROCHE Group
Accelerating therapeutics to patients through innovative operations and quality assurance practices. Improving cross-functional Risk Based Quality Management practices through a robust, organizational Quality Culture with a focus on impactful quality outcomes. Clinical enterprise... Read More →
avatar for Sharon Reinhard

Sharon Reinhard

Clinical Quality Expert, Independent Consultant
Experienced pharmaceutical executive with 25 years of industry experience, including roots in academia. Most recently Head of Commercial and R&D Quality at AVEO Oncology.  Prior to that, Vice President/ Head of Quality at AVROBIO, a gene therapy company focused on lysosomal storage... Read More →


Thursday May 23, 2024 3:00pm - 3:15pm EDT
  Included in VIRTUAL Experience
 
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