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4th European Clinical Quality Risk Management Forum
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Monday, February 24
 

8:00am

9:00am

Chairperson's Welcome and Opening Remarks
Speakers
avatar for David Fryrear

David Fryrear

Senior Vice President, Head of Clinical and Research Quality Assurance, ASTELLAS
David Fryrear, M.S., is the Medical and Development organization’s senior vice president and head of the Clinical and Research Quality Assurance (CRQA) organization and has responsibility for providing the global vision, leadership and strategic direction of CRQA at Astellas.Fryrear... Read More →


Monday February 24, 2020 9:00am - 9:30am

9:30am

Senior Leaders Panel: Proactive Risk Management Post ICH E6 R2
Identify and Implement Proactive Clinical Risk Management Approaches That Comply With ICH E6 R2 

  • Examine what constitutes a proactive risk management approach
  • Evaluate how ICH E6 R2 is driving the shift from reactive to proactive risk management
  • Understand the role of quality culture when moving to a more proactive approach
  • Leverage analytics to develop a proactive quality strategy
  • Identify the most important elements needed to implement a proactive risk management approach

Speakers
avatar for Patricia Pengelly

Patricia Pengelly

R&D Quality Assurance Head EMEA, ABBVIE
Patricia has over 20 years’ experience in the pharmaceutical industry starting her career in 1997 working in the biotech sector as a Pharmacovigilance specialist.  For 5 years she was Pharmacovigilance Head at a start-up biotech company, which was developing innovative oncology... Read More →
avatar for Kerstin Koenig

Kerstin Koenig

Vice President, Global Head Research and Development Quality, MERCK
Kerstin Koenig, PhD is the Head of Research & Development Quality, Merck Healthcare KGaA, Darmstadt, Germany. In this role, she is responsible for the development and strategic oversight of the world-wide quality assurance and quality management activities in the area of Good Research... Read More →
avatar for Becky Merlina, RPh

Becky Merlina, RPh

Head, R&D Quality, ADVANCED ACCELERATOR APPLICATIONS (AAA), a Novartis Company
Becky Merlina was appointed Head of R&D Quality for Advanced Accelerator Applications (AAA), a Novartis company, in 2019.   She had previously joined Endocyte in December 2018, as the Vice President of Quality prior to its acquisition by Novartis..  AAA is a pioneer in the field... Read More →


Monday February 24, 2020 9:30am - 10:30am

10:30am

30-Minute Networking and Refreshment Break
Monday February 24, 2020 10:30am - 11:00am

11:00am

Regulatory Update: MHRA Inspections
Examine Common Findings and Trends in MHRA GCP Inspections 
  • Evaluate how MHRA inspections have and are changing 
  • Walk through what to expect during an MHRA inspection
  • Review adaptive design trials and implications for inspections 
  • Update on inspectorate
  • Discuss best practices for responding to findings and subsequent regulatory correspondence




Speakers
avatar for Paula Walker, MA, BSc

Paula Walker, MA, BSc

Inspectorate Unit Manager, GCP/GPvP/GLP, MHRA
Paula Walker has been with the MHRA for over 10 years, joining in 2009 as a GCP inspector, and subsequently moving to the role of Operations Manager for the GCP team in 2013.  Paula has been the Inspectorate Unit Manager since November 2018 responsible for the GCP, GPvP, GLP & Laboratories... Read More →


Monday February 24, 2020 11:00am - 12:15pm

12:15pm

Lunch for Conference Participants
Monday February 24, 2020 12:15pm - 1:15pm

1:15pm

Compare and Contrast Inspections by Different Agencies
Examine the Differences in the Conduct of Inspections by Different Regulatory Agencies and the Impact on Inspection Ready Processes 
  • Explore the largest differences in inspection duration, number of inspectors, practicalities and logistics between agencies when conducting sponsor and investigator site inspections
    • Outside of the main inspectorates/markets, insight into special practices of local authorities
  • Understand how inspection preparation activities should change depending on the agency
  • Review relevant guidance documents, most notably ICH E6 R2, and how they can be used to support preparation activities

Speakers
avatar for Heike Reinstaedtler

Heike Reinstaedtler

Head, Clinical and Medical Quality, GSK VACCINES
Heike serves as Head of Clinical and Medical Quality at GSK Vaccines, a global team responsible for quality oversight and support enabling proactive, integrated and risk-based quality management throughout the clinical and epidemiology study processes. Her focus is to partner with... Read More →


Monday February 24, 2020 1:15pm - 2:00pm

2:00pm

Mock Inspections
Leverage Mock Inspections to Ensure a Constant State of Inspection Readiness
  • Understand the purpose of a mock inspection and mock interviews and effectively articulating this to your team
  • Strategize and plan your own mock inspection
  • Leverage the mock interview to train staff on best practices and what not to do
  • Implement follow-up activities for areas that need improvement

Speakers
avatar for Katharina Kurpanek

Katharina Kurpanek

Managing Director, THE QM COMPANY; Former BfArM GCP INSPECTOR
Katharina Kurpanek is the founder and Managing Director of The QM Company. She is a clinical research professional and GCP expert with a broad range of quality management experience including over 6 years as GCP Inspector with BfArM (German regulatory authority) and EMA, and a total... Read More →


Monday February 24, 2020 2:00pm - 2:45pm

2:45pm

30-Minute Networking and Refreshment Break
Monday February 24, 2020 2:45pm - 3:15pm

3:15pm

Trial Master File
Manage Risk while Maintaining Quality of your Trial Master File (TMF) 
  • Ensure the risk of non-compliance associated with the TMF is proactively identified and managed
  • Execute monthly metrics on TMF to assess overall health and uncover any possible issues
  • Develop strategies for working with vendors to ensure the TMF reflects the integrity of the trial
  • Leverage the TMF as an oversight tool to gauge the overall performance of partners

Speakers
avatar for Marion Mays

Marion Mays

Vice President, Client Solutions and Quality Assurance, PHLEX GLOBAL
Marion Mays has worked for 23 years in the pharmaceutical industry and eight years as a leader in the Information Management division. She has implemented global records management processes, cloud-based and secure document management solutions for the Trial Master File (TMF), along... Read More →


Monday February 24, 2020 3:15pm - 4:00pm

4:00pm

CRO-Vendor Oversight Plan
Define the Framework and Critical Elements of an Effective CRO-Vendor Oversight Plan
  • Identify the components that comprise a comprehensive framework for effective quality oversight of your CRO partner
  • Discuss how to implement quality oversight
  • Evaluate the critical elements for a successful CRO-Vendor oversight plan, including what to measure so risk is reduced and outcomes are improved

Speakers
avatar for Brigid Flanagan, BA, RN, CCRC, MSB

Brigid Flanagan, BA, RN, CCRC, MSB

Senior Consultant, The Avoca Group
Brigid Flanagan is a research professional with 20+ years in clinical operations. In her role as Senior Consultant for The Avoca Group, Brigid provides input on operational plans, vendor qualification, and oversight for pharmaceutical clients conducting trials in the US and EU. She... Read More →


Monday February 24, 2020 4:00pm - 4:45pm

4:45pm

 
Tuesday, February 25
 

8:15am

9:00am

Chairperson's Recap of Day One and Opening to Day Two
Speakers
avatar for David Fryrear

David Fryrear

Senior Vice President, Head of Clinical and Research Quality Assurance, ASTELLAS
David Fryrear, M.S., is the Medical and Development organization’s senior vice president and head of the Clinical and Research Quality Assurance (CRQA) organization and has responsibility for providing the global vision, leadership and strategic direction of CRQA at Astellas.Fryrear... Read More →


Tuesday February 25, 2020 9:00am - 9:30am

9:30am

The GCP-PV Interface
Execute Successful GCP and PV Interfaces to Ensure Safety Topics and Issues are Managed Compliantly and Effectively  
  • Understand the importance of an integrated approach to safety topics and associated issue management
  • Ensure safety issues are being appropriately addressed through continued oversight of both PV and GCP business and quality organisations
  • Discuss examples of GCP/PV cross functional working to ensure compliance with safety requirements in the clinical trial setting

Speakers
avatar for Rebecca Webb

Rebecca Webb

Director, Pharmacovigilance Quality Assurance, ABBVIE


Tuesday February 25, 2020 9:30am - 10:15am

10:30am

Networking and Refreshment Break
Tuesday February 25, 2020 10:30am - 11:00am

10:45am

PANEL DISCUSSION - Issue Management
Discuss How to Effectively and Appropriately Manage Issues and Determine Their Severity 
  • Examine available guidelines and regulations on serious breach
  • Assess the impact of EUCTR on issue management and serious breach
  • Strategize on how to determine what should and should not be classified as a serious breach
  • Review various examples of issues and discuss how they were handled

Speakers
avatar for David Fryrear

David Fryrear

Senior Vice President, Head of Clinical and Research Quality Assurance, ASTELLAS
David Fryrear, M.S., is the Medical and Development organization’s senior vice president and head of the Clinical and Research Quality Assurance (CRQA) organization and has responsibility for providing the global vision, leadership and strategic direction of CRQA at Astellas.Fryrear... Read More →
avatar for Karen Hue

Karen Hue

Quality Assurance Director, Europe, AIMMUNE THERAPEUTICS
Karen graduated with a B.Sc. in Applied Biology specialising in pharmacology followed later on with a diploma in total quality management. Her career started in toxicology in preclinical research followed by a short spell working in transplantation in Addenbrooke’s and Papworth... Read More →
avatar for Heike Reinstaedtler

Heike Reinstaedtler

Head, Clinical and Medical Quality, GSK VACCINES
Heike serves as Head of Clinical and Medical Quality at GSK Vaccines, a global team responsible for quality oversight and support enabling proactive, integrated and risk-based quality management throughout the clinical and epidemiology study processes. Her focus is to partner with... Read More →


Tuesday February 25, 2020 10:45am - 11:45am

11:45am

Clinical Data Integrity
Examine What Practices and Tools Are Being Utilized to Ensure Clinical Data Integrity 
  • Examine the current data integrity guidelines – where they come from and what they mean
  • Identify the risks to data integrity in today’s clinical research arena
  • Discuss key areas of focus and concern by regulatory agencies regarding data integrity in clinical research
  • Review regulatory trends in data integrity
  • Share recent regulatory findings pertaining to data integrity and discuss recommendations to prevent similar findings for your company
  • Strategize on how to achieve data integrity compliance
  • Benchmark common data integrity compliance oversight responsibilities across the industry
  • Discuss actions to establish and maintain a data integrity compliance organization

Speakers
avatar for Devry Spreitzer

Devry Spreitzer

Director, Global Electronic Systems Quality Assurance, ASTELLAS
Devry Spreitzer is the Director of Electronic Systems Quality Assurance at Astellas Pharmaceutical Global Development, Inc. He has 24 years of experience working in the Pharma industry in the areas of Data Integrity, Electronic Records / Electronic Signatures regulations, computer... Read More →


Tuesday February 25, 2020 11:45am - 12:30pm

12:30pm

Lunch for Conference Participants
Tuesday February 25, 2020 12:30pm - 1:30pm

1:30pm

The Impact of ICH E6 and E8 Revisions
Understand How and Why GCP is Being Modernized Through Revisions to ICH E6 and E8 and What This Means For Today’s Operations  
  • Evaluate the basis for the modernization and goals meant to be achieved
  • Understand the approach to the modernization from a tactical perspective
  • Introduce evolving quality concepts and critical to quality factors in clinical trial design and execution
  • Assess what these current and upcoming changes mean for your

Speakers
avatar for Kerstin Koenig

Kerstin Koenig

Vice President, Global Head Research and Development Quality, MERCK
Kerstin Koenig, PhD is the Head of Research & Development Quality, Merck Healthcare KGaA, Darmstadt, Germany. In this role, she is responsible for the development and strategic oversight of the world-wide quality assurance and quality management activities in the area of Good Research... Read More →


Tuesday February 25, 2020 1:30pm - 2:15pm

2:15pm

INTERACTIVE DISCUSSION - The Latest Inspection Buzz
Share Observations and Lessons Learned from Recent Inspection Experiences and What This Buzz Means for Your Inspection Preparations
  • Evaluate recent inspection experiences and observed trends 
  • Assess how inspections have changed regarding what inspectors expect and require
  • Identify common obstacles and challenges during an inspection and strategies for overcoming them
  • Outline best practices for managing expectations and preparation strategies


Tuesday February 25, 2020 2:15pm - 3:15pm

3:15pm

Chairperson's Concluding Remarks
Speakers
avatar for David Fryrear

David Fryrear

Senior Vice President, Head of Clinical and Research Quality Assurance, ASTELLAS
David Fryrear, M.S., is the Medical and Development organization’s senior vice president and head of the Clinical and Research Quality Assurance (CRQA) organization and has responsibility for providing the global vision, leadership and strategic direction of CRQA at Astellas.Fryrear... Read More →


Tuesday February 25, 2020 3:15pm - 3:30pm