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Risk-Based Monitoring [clear filter]
Sunday, June 26
 

1:00pm EDT

#37: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
Limited Capacity seats available

Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

The current clinical trial climate demands that sponsors find ways to reduce clinical trial complexity, drug development costs, and get more value from R&D budgets. Risk-based monitoring (RBM) allows organizations to target site monitoring activities for which risks can be best managed and deliver the greatest benefit to the study, and to become more effective and efficient in using resources, while increasing quality and patient safety. Participating TransCelerate Member Companies came together in 2012 to establish a model approach to high-quality RBM. To date, this effort has published a position paper on RBM, as well as several articles focused on sharing advancements, best practices and lessons learned from member companies adoption experience, all of which are publicly available. This tutorial, hosted by TransCelerate BioPharma, Inc., will define core concepts and main principles of the methodology, share key tools and discuss their use, share experiences and lessons learned, and address important questions about RBM and its implementation.

Who should attend?

This tutorial is designed for professionals involved with clinical and data operations.

Learning Objectives

• Define core concepts and main principles of the TransCelerate risk-based monitoring (RBM) methodology;
• Discuss the use of key tools in the RBM process;
• Identify common challenges with effective monitoring and discuss how they can be addressed through appropriate use of the RBM methodology.


Speakers
avatar for Joanne Benedict

Joanne Benedict

Senior Advisor, Genentech, A Member of the Roche Group
Joanne Benedict is a Senior Advisor in Roche Genentech's Process, Training, and Systems group. She develops business strategies, processes, and systems which support continuous improvement and innovation in clinical trials. Specializing in operations, technology, and process optimization... Read More →
avatar for Lisa Horne-Lucero

Lisa Horne-Lucero

Consultant, RBM Operations, Clinical Risk Management, Eli Lilly and Company
Lisa is an RBM Operations Consultant in Eli Lilly’s Clinical Risk Management organization. She develops and implements RBM processes, procedures and training as she guides study teams through the RBM implementation process. She has been a key leader in the implementation of RBM... Read More →


Sunday June 26, 2016 1:00pm - 4:30pm EDT
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Tutorial |   Preconference Tutorial, Tutorial
 
Monday, June 27
 

10:45am EDT

#124: Risk-Based Monitoring in Clinical Trials
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-518-L05-P; CME 1.25; IACET 1.25; RN 1.25

This symposium will examine the implementation of risk-based monitoring strategies in clinical trials and their impact on site performance, patient safety, data integrity, and study quality.

Learning Objectives

Discuss how risk-based monitoring (RBM) can help investigator sites improve overall site performance, with higher efficiency and improved patient safety; Describe best practices in site/CRO partnering to successfully drive efficiencies and improve oversight of patient safety and data quality; Identify the importance of planning the RBM strategy in order to make it actionable.

Chair

Ellen Kelso

Speaker

How to Successfully Plan and Implement a Risk-Based Monitoring Strategy
Francois Torche, MBA

Risk-Based Monitoring: What Does It Mean for Clinical Study Sites?
Jill Collins

The Impact of Risk-Based Monitoring on Site Performance: Reducing Risks While Improving Patient Safety and Study Quality
Robin Douglas, MA



Chair
avatar for Ellen Kelso

Ellen Kelso

Executive Director, Chesapeake IRB
Founder, managing member & CEO of Goodwyn IRB, Ellen Kelso is recognized for her experience & expertise in clin. trial mgt & reg. affairs. Has provided educ., consultation & services to the pharma industry supporting clinical research & regulatory strategies, submissions & compliance... Read More →

Speakers
avatar for Jill Collins

Jill Collins

Executive Director, Global Operations management, Innovation, INC Research
Jill Collins, Executive Director, Global Operations Management, Innovation at INC Research, with 20 years of experience in clinical operations, leads the development of transformative approaches to trials with a focus on data-driven process optimization, including INC’s RBM solution... Read More →
RD

Robin Douglas

Site Solutions Director, Site and Patient Networks, Quintiles
Robin Douglas has 22 years of clinical research experience, including 16 years as a site manager / administrator. Currently Robin serves as Site Solutions Director at Quintiles. Her core responsibility is to ensure an enhanced site experience when working with Quintiles which includes... Read More →
avatar for Francois Torche

Francois Torche

Chief Executive Officer, CluePoints
François holds a Master in Business Administration from the ICHEC School of Management, Brussels. Over the past 19 years in the pharmaceutical industry, he has held positions as statistical programmer, developer and IT project leader for companies such as GSK, UCB and IDDI. During... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Symposium
 
Tuesday, June 28
 

2:00pm EDT

#234: TransCelerate's Risk-Based Monitoring: Sharing What We Are Learning
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

TransCelerate members will share successful risk-based monitoring (RBM) implementation lessons learned during this interactive session. Regulators, sponsors, CROs and clinical research site personnel will gain practical insight for an RBM implementation strategy.

Learning Objectives

Discuss successful practices and lessons learned through an evaluation of TransCelerate company risk-based monitoring (RBM) studies and recent publications; Describe key change considerations needed to successfully implement an RBM strategy both from a site and sponsor perspective; Summarize what this unique collaboration of 20+ sponsors is doing to assist vendors in understanding the technology gaps with respect to existing tools and systems that support RBM methods.

Chair

Brett Wilson

Speaker

TransCelerate RBM Successful Practices and Lessons Learned
Joanne Benedict, MSc

TransCelerate's Approach to Understanding and Managing Site and Other Stakeholder Expectations, Wants, and Needs
Kate Owen

Site Representative
Allison Camacho

Searching for a Technology Solution to Support Risk-Based Monitoring
Mary Cusack



Chair
avatar for Brett Wilson

Brett Wilson

Head, Monitoring Excellence, Bristol-Myers Squibb Company
Brett Wilson, BSP, is Head of Monitoring Excellence at Bristol-Myers Squibb and leads both Risk Based Monitoring and eSource initiatives with TransCelerate BioPharma. Within BMS, Brett is responsible for ensuring an accountable and sustainable adaptive monitoring model focused on... Read More →

Speakers
avatar for Joanne Benedict

Joanne Benedict

Senior Advisor, Genentech, A Member of the Roche Group
Joanne Benedict is a Senior Advisor in Roche Genentech's Process, Training, and Systems group. She develops business strategies, processes, and systems which support continuous improvement and innovation in clinical trials. Specializing in operations, technology, and process optimization... Read More →
AC

Allison Camacho

Research Manager, Dallas Diabetes and Endocrine Center
Allison Camacho joined Dr. Julio Rosenstock as his Research Manager of the Dallas Diabetes and Endocrine Center in 2002. Currently, Allison’s responsibilities include managing eight coordinators, five supporting staff, and manages the budgets and contracts for the site, ensuring... Read More →
avatar for Mary Cusack

Mary Cusack

Associate Director, Global Clinical Operations, Bristol-Myers Squibb Company
Mary has over 17 years of pharmaceutical experience of which over half have been spent at Bristol-Myers Squibb in Global Clinical Operations. Mary serves as the Business Integration Lead. In this capacity, she has responsibility to manage technical implementations within clinical... Read More →
avatar for Kate Owen

Kate Owen

Vice President, Clinical Trial Management, Novo Nordisk Inc.
Kate is the Vice President of Clinical Trial Management at Novo Nordisk (Princeton, NJ) with 22 years’ experience within the biotech, pharmaceutical and CRO space. Her leadership has led to improved productivity, cost-effectiveness, quality and staff morale. She sponsors the Novo... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Session

4:00pm EDT

#278: Real Life Application of Risk-Based Monitoring
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

This session will include a facilitated discussion about common application experiences applied through case-based learning and will encourage audience members to share similar or different experiences in their risk-based monitoring implementations.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Explain how to apply the implementation lessons of risk-based monitoring to your own situation.

Chair

Brett Wilson

Speaker

Facilitator
Lisa Horne-Lucero, BSN

Facilitator
Kate Owen



Chair
avatar for Brett Wilson

Brett Wilson

Head, Monitoring Excellence, Bristol-Myers Squibb Company
Brett Wilson, BSP, is Head of Monitoring Excellence at Bristol-Myers Squibb and leads both Risk Based Monitoring and eSource initiatives with TransCelerate BioPharma. Within BMS, Brett is responsible for ensuring an accountable and sustainable adaptive monitoring model focused on... Read More →

Speakers
avatar for Lisa Horne-Lucero

Lisa Horne-Lucero

Consultant, RBM Operations, Clinical Risk Management, Eli Lilly and Company
Lisa is an RBM Operations Consultant in Eli Lilly’s Clinical Risk Management organization. She develops and implements RBM processes, procedures and training as she guides study teams through the RBM implementation process. She has been a key leader in the implementation of RBM... Read More →
avatar for Kate Owen

Kate Owen

Vice President, Clinical Trial Management, Novo Nordisk Inc.
Kate is the Vice President of Clinical Trial Management at Novo Nordisk (Princeton, NJ) with 22 years’ experience within the biotech, pharmaceutical and CRO space. Her leadership has led to improved productivity, cost-effectiveness, quality and staff morale. She sponsors the Novo... Read More →


Tuesday June 28, 2016 4:00pm - 5:00pm EDT
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

2:00pm EDT

#349: Measuring the Effectiveness of Risk Minimization: Principles and Regional Requirements
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-601-L04-P; CME 1.25; IACET 1.25; RN 1.25

Measuring effectiveness of risk minimization activities is an essential part of risk management, but doing it can be challenging. Experts will discuss requirements in different regions, CIOMS IX, possible methodologies, and the challenges.

Learning Objectives

Describe the importance of measuring the effectiveness of risk minimization activities and the requirements in different regions; Discuss the different methodologies for measuring effectiveness; Discuss opinions from regulatory, industry, and contract research on the challenges of measuring effectiveness.

Chair

Stella C.F. Blackburn

Speaker

Risk Management Plans and Risk Minimization: What Have We Learned and Where Is It All Going?
Shelley Gandhi, MS

CIOMS IX and the Theory of Assessing Effectiveness
Stella C.F. Blackburn

Additional Risk Minimization Measures for EU Centrally Authorized Products, 2006-2014: A Qualitative and Quantitative Review
Annalisa Rubino, PhD



Chair
avatar for Stella Blackburn

Stella Blackburn

Vice President, Global Head of Early Access & Risk Management, RWI, QuintilesIMS
Dr Stella Blackburn is currently VP, Global Head of Early Access & Risk Management at QuintilesIMS. She joined QI in April 2014 after more than 25 years working in PhV and pharmacoepi in industry and the European Medicines Agency. Stella is a Fellow of the International Society of... Read More →

Speakers
avatar for Shelley Gandhi

Shelley Gandhi

Strategic Advisor, Pharmacovigilance and Drug Safety, NDA Group
Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented... Read More →
AR

Annalisa Rubino

Director of Risk Management Epidemiology, Oxon Epidemiology
Annalisa Rubino is Director of Risk Management Epidemiology with OXON Epidemiology. She is a Pharmacoepidemiologist with extensive research experience in drug development in academia and industry. She has worked in consultancy for the pharmaceutical industry in therapeutic risk management... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety-PV, Session

4:00pm EDT

#362: Risk-Based Monitoring: Best Practices in Implementation for the Data Manager and Key Stakeholders
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-534-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will explore how companies are implementing successful risk-based monitoring (RBM), with particular emphasis on the realignment of processes and roles, and applying central monitoring and data quality oversight to support the RBM strategy.

Learning Objectives

Define key challenges in risk-based monitoring (RBM) implementation; Identify how processes and roles need to change in the organization to support the RBM; Discuss real-time analytics as a key enabler to achieve adaptive, centralized monitoring; Demonstrate how results from analytics can be turned into actionable items to mitigate risks.

Chair

Teresa Ancukiewicz, MA

Speaker

Lessons Learned in Implementing Risk-Based Monitoring and eSource: The Data Manager’s Expanded Role
Vadim Tantsyura

Risk-Based Monitoring Best Practices for the Data Manager: Lessons Learned from Sponsors and Sites
Amita Malik, MS

Using Powerful and Pragmatic Central Statistical Analytics to Drive Quality into Clinical Trials
Erik Doffagne, MSc



Chair
avatar for Teresa Ancukiewicz

Teresa Ancukiewicz

Senior Manager, Clinical Data Management, Boston Scientific Corporation
Senior Manager in Clinical Operations at Boston Scientific, CCDM. Responsible for providing leadership on outsourcing initiatives and Risk Based Monitoring. Over 20 years of experience in data management, process development and improvement, and vendor management. Active in the DIA... Read More →

Speakers
avatar for Erik Doffagne

Erik Doffagne

Product Manager, CluePoints
Erik holds a bachelor degree in Computer Science and a master degree in Biostatistics. He has more than 10 years of experience in the life science industry. Erik has spent the last 5 years at developing methodology and technology for central statistical monitoring. Erik has co-authored... Read More →
avatar for Amita Malik

Amita Malik

Senior Manager, Product Management, Oracle Health Sciences
Senior Manager in Oracle Health Sciences Product Management organization, responsible for providing product leadership on current market leading Clinical Data Acquisition and Management products. Prior to Oracle, worked at Phase Forward and led delivery of large scale technology adoption... Read More →
avatar for Vadim Tantsyura

Vadim Tantsyura

Director, Data Management, Target Health Inc.
Dr. Tansyura has 15+ years of pharmaceutical experience, including a Head of DM role at Regeneron, Infinity and Cincinnati Children's Hospital. Dr. Tantsyura is a co-founder and member of the Advisory Board for OpenCDISC (2008-2010) and SCDM board member (2014-2016). Dr. Tantsyura... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm EDT
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech-Data- Records-Subs, Session