San Francisco Professional Events List


The 7th Trial Master File Summit (EXL)


Date
Jan 16, 2018 - 08:00 AM
Organizer
NYMT
Location
Hyatt Regency Grand Cypress1 Grand Cypress BoulevardOrlando, FL 32836United States,

Orlando,
FL,
US,
ZIP: 32836
Phone:

The Biggest TMF Event Ever!
If you are going to attend only one event — this is it! If you were planning to take a year off — this is not the year!

With 40% more sessions than last year and 25% more speakers, this year’s participants will be better able to tailor their experience to their particular needs.

Come and learn from the best with the best! 
The collegiality of the speaking faculty is matched by the fellowship among participants that is wrought by their zeal for continuous improvement to share and learn.

A TMF is more than a living archive of a clinical trial’s progress; it is a system required by regulatory authorities and is critical for clinical oversight. By developing, implementing and utilizing a sound TMF plan, you will be able to monitor a trial as it advances, ensure high-quality documents and prepare your organization for an inspection at any stage. Additionally, by creating a TMF process, the clinical trial’s sponsors, CRO and site will be able to demonstrate their continued adherence to GCP during the trial.

At the 7th Trial Master File Summit, 40+ speakers will share best practices on a wide range of topics including:

  • Quality TMF improvement
  • System migration and eTMF implementation.
  • Determining and Managing Relevant communications in the TMF.
  • Completeness review by the study team and how to streamline this process.
  • Maintaining a real time TMF/Implementing Processes to maintain a real time eTMF.
  • Senior Management acceptance/funding/championing of eTMF implementation.
  • Metrics with CRO and internal staff.
  • How to construct a successful TMF team.
  • Involving functions in TMF.
  • Relevant correspondence, working with CRO partners, Inspection Readiness.
  • Document management and processes.
  • TMF QC or TMF Process Implementation.
  • Inspection Readiness, Metrics, Sponsor Oversight Responsibilities.
  • Nothing specific at this time.
  • CRO's and their SOP's and standards.
  • Study Close-out/Transfer.
  • How to set up a successful TMF staff. How to reduce the number of correspondence by downsizing the number of emails.

Top Five Reasons to Attend

  1. Learn from case studies and best practices for designing and implementing a TMF plan for global trials and inspectional readiness.
  2. Networking and learn with over 250 TMF colleagues.
  3. Hear updates on the DIA reference model and MCC’s metrics working group.
  4. Develop a TMF strategy to ensure proper TMF oversight.
  5. Explore the latest trends, preparations and expectations for TMF inspections from the FDA, EMA, MHRA and PMDA.

Who Should Attend

This conference is designed for representatives from pharmaceutical, biotech, medical device and clinical research companies with responsibilities in the following areas:

  • TMF and eTMF Management
  • Clinical Document/Data Management
  • Clinical Trial Administration
  • Clinical Operations
  • Regulatory Affairs/Operations
  • Trial, Document and Record Management
  • Clinical Document Coordination
  • Clinical Development/Study Management
  • Quality Assurance/Control/Operations
  • Competency Development
  • Strategic Operations and Planning
  • Quality Management
  • Informatics
  • Clinical IT

This event is also of interest to:

  • eTMF Service Providers
  • Data/Records Management Vendors
  • Clinical Research Organizations
  • Paper and Electronic Archiving Solution Providers

Agenda

Pre-Conference TMF Training Day | Tuesday, January 16, 2018 7:30AM

Registration and Continental Breakfast Begin

8:00AM

BUILDING THE FOUNDATION Breakfast Workshop

The management of the Trial Master File, the content created in support of a clinical study, doesn’t have to be complicated. It can be as easy as 1-2-3 if a pragmatic approach is taken. The first step is to know what exactly is the TMF and define what is in “it.” The next step is to associate the TMF content in all its forms to its Owners. The last step is to establish process to ensure the TMF is inspection-ready at all times. Included in this workshop will be the presentation of typical problems incurred by companies establishing the TMF and its associated management processes. Audience feedback will be sought for the sharing of ideas to overcoming the challenges.

This workshop is geared towards those who are new to the TMF field, though all levels of experience can benefit from attending. Concepts addressed will allow the attendee to build/expand their foundation so they then can get the most out of the remainder of the Summit. Experienced workshop leaders will present as well as lead attendees through exercises that incorporate solutions to challenges that TMF professionals face. The workshop will address the following:

  • Using the TMF Reference Model to outline what’s in the TMF, and who owns the content
  • Review of the industry accepted requirements for management by those that create, collect, and also manage the TMF
  • Guidances, laws, and regulations that define and govern the TMF in the U.S., EU, and Japan
  • Typical problems faced and corresponding solutions

Louise HawkinsClinical Operations ManagerAGIOS 
Lisa MulcahyOwner and Principal ConsultantMULCAHY CONSULTING

11:00AM

Breakfast Workshop Concludes

11:30AM

KEYS FOR SUCCESS: OPERATIONALIZING YOUR TMF Lunch Seminar

If you are tasked with establishing the TMF management process at your company, you know that the end goal of having an inspection-ready TMF on an ongoing basis doesn’t just magically happen after the TMF management process is created and made effective. The work involved with successfully convincing into action and compliance 10, 15, 20 different functional groups to follow the defined processes is not small. Any success experienced does not come without a significant amount of assistance and oversight of the process by the TMF management team to ensure it is being followed according to expectations.

This seminar will be conducted using a carousel approach. Every group will have the opportunity to address a TMF challenge in timed segments. All groups will summarize the how they interpret the challenge and propose known working potential quick wins and long-term solutions for success based on their group members’ experiences.

  • Attendee-chosen challenges regarding the operationalizing of the TMF management process will be discussed with corresponding solutions proposed
  • An overview of the methodology for engaging people to be part of the solution instead of the problem will be provided

Lisa MulcahyOwner and Principal ConsultantMULCAHY CONSULTING 
Supriya ShoroffAssociate Director, TMFSAGE THERAPEUTICS

4:30PM

Seminar Concludes

5:00PM

OUTLINE YOUR MANAGEMENT OF THE TMF Dinner Workshop

The TMF Management Plan is a document that outlines the management of the TMF for a study. Standard industry practice dictates that a TMF Management Plan be created for each clinical study. However, the topics addressed within the TMF Management Plan can vary widely from company to company. The MHRA has provided an outline of topics important for inclusion in the plan and industry has identified additional ones based on best practices.

This workshop will review the expectations and best practices for topics to include in the TMF Management Plan. A few of the more complicated topics including expectations for quality reviews will be discussed in detail through small group exercises. Approaches for how, when, who and what will be presented by sponsor representative as well as the management of the outcome of the quality review and evidence of this conduct. This workshop promises a lively discussion that all attendees will benefit from; even those new to the TMF management field of work. Topics that will be addressed during this workshop are:

  • The TMF Management Plan in the eyes of the health authority representative
  • Why the TMF Management Plan is so crucial to the overall TMF management process
  • Definition of what is a quality review, how often one is to occur, tools used to conduct a quality review, and the evidence created as a result of the activity

Lisa MulcahyOwner and Principal ConsultantMULCAHY CONSULTING 
Jamie TothHead of TMF OperationsDAIICHI SANKYO

8:00PM Dinner Workshop Concludes

Conference Day One, Plenary Sessions | Wednesday, January 17, 2018 12:00AM

Registration and Continental Breakfast Begin

8:45AM

Summit Chairpersons’ Opening Remarks
Marie-Christine Poisson-CarvajalTMF Operations LeadPFIZER 
Karen RoySenior Vice President, Client SolutionsPHLEXGLOBAL 
Jamie TothHead of TMF OperationsDAIICHI SANKYO

9:00AM

Begin and Maintain a Continuously Inspection-Ready TMF Based on ICH GCP E6(R2) and Other Impending Updates
  • Get regulatory updates and discuss the anticipated impact of GCP E6(R2)
  • Implement a governance process that will cover the full life cycle of the TMF
  • Pinpoint the critical components of keeping a TMF ready for inspection
  • Utilize an information architecture system to ensure high-quality documentation
  • Incorporate efficient SOPs to integrate the TMF across all partners
 

9:30AM

Case Study Focus on Quality by Conducting a Comprehensive TMF Review
  • Ensure that the TMF specifications account for the protocol and design specifications, study operational components and events
  • Improve TMF quality by analyzing the interrelationships of documents
  • Achieve risk-based QC through a holistic approach and a comprehensive review of documents individually and collectively to ensure content quality
  • Perform a comprehensive TMF Content Review to be inspection-ready by performing logical checks
  • Review documents as they related to each other, reconcile filing/indexing issues and identify gaps
  • Improve TMF quality by analyzing the systemic connections of your study to your TMF

Marie-Christine Poisson-CarvajalTMF Operations LeadPFIZER

10:00AM

Session By:
Sharon AmesDirector, Client SolutionsPHLEXGLOBAL & RHO
TBD, RHO

10:30AM

Networking Break

11:00AM

Presentation by VEEVA SYSTEMS

11:30AM

Ensure Inspection Readiness From the Beginning
  • Build and develop a team according to trial demands of the trail and third-party needs
  • Determine set checkpoints for the life cycle of the trial
  • Set up your TMF before the start of the trial
  • Establish clear expectations and providing adequate and impactful coaching and training
  • Examine common impediments to inspection readiness of TMF and eTMF resulting from M&A

Alana WrigginsHead Site Management, North America, Global Site Management OperationsALLERGAN

12:00PM

Create Effective QC Process for Documents in Electronic and Paper Formats
  • Establish a process to assess and improve quality assurance practices
  • Vet tactics for meeting quality requirements when rolling out an eTMF system
  • Discuss tools and processes for TMF assessment
  • Conduct quality checks and expected versus missing documents

Wendy TrimboliHead of TMF Process Management and QCEISAI

12:30PM

Ensure GCP and Harmonization by Bringing Your TMF In-House
  • Discover why this is a growing trend and the circumstances that make this advantageous
  • Discuss case examples of migrations would take place
  • Avoid non-noncompliance issues and through QC
  • What happens to eTMF/eTMF data in third-party system and how do you extract artifacts and emails?
  • Discuss site oversight and management considerations
  • Identify threats to compliance and data integrity
  • What to do when you think you are done

Sholeh EhdaivandPresident and CEOLMK CLINICAL RESEARCH CONSULTING 
Jackie MorrillDirector of Clinical OperationsLMK CLINICAL RESEARCH CONSULTING

1:00PM Luncheon

Conference Day One, Tracked Sessions | Wednesday, January 17, 2018 

eTMF Implementation 

Metrics and Tools 

2:00PM

Case Study Survey the Triumphs and Challenges of a Large-Scale eTMF Implementation on a Short Timeline
  • Glean lessons from GSK's experience transitioning to the TMF Reference Model
  • Study strategy for R&D-wide implementation from leveraging early adopters to full rollout
  • Look at governance best practices and processes and avoid pitfalls
  • Discuss impediments for implementation and the tactical ways that GSK coped with them
  • Aspire for continuous improvement and sustainability

Mike CzaplickiClinical Documentation Operations ManagerGSK
Oversee and Manage Vendors to Ensure Inspection Readiness With Standard Metrics
  • Engage vendors and internal stakeholders to ensure inspection readiness
  • Manage vendor/stakeholder performance and process improvement
  • Improve collaboration using strategic standards and KPIs
  • Align objectives, strategy and relationships

Wendy KellyManager, Global DevelopmentSUNOVION

2:30PM

Improve Your TMF Process by Creating a Collaborative Culture That Empowers Teams
  • Leverage the experience of your team on the ground to identify priority improvements
  • Invest in your team to build commitment and improve TMF and inspection-readiness expertise
  • Reward individual and team accomplishments with meaningful project and process ownership
  • Promote a culture of interdependence and shared success while driving improvement across the clinical study life cycle

Eric RubinsonFormer Executive Director, Clinical Records ManagementALLERGAN
Panel Use Metrics and Benchmarks to Improve TMF Management
  • Conduct and orchestrate activities by leveraging how quality metrics
  • Leverage metrics to improve the process and engage CROs’ investment
  • Identify the right set of TMF metrics for your organization
  • Study the impact of stakeholder oversight and metrics when a TMF is managed by a sponsor versus a CRO
  • Compare challenges faced by smaller and larger companies

Panelists:

Allison GrosikSenior Associate, TMF Management and ComplianceEISAI 
Tyler PraterClinical Trial ManagementELI LILLY

3:00PM

Networking Break

3:30PM

Panel Establish Milestones for Piloting, Implementing and Executing a TMF System
  • Address the scope of the eTMF and define graduations of eTMF and TMF maturity
  • Implement a pilot and ramp up phases while having a parallel paper and electronic version of the TMF
  • Discuss strategies for propelling your organization along the TMF continuum
  • Leverage industry benchmarks to drive process improvement

Moderator:

JP MiceliAssociate Director, Clinical Document ManagementSHIRE


Case Study Meet Business Imperatives and eTMF Requirements by Configuring an eTMF System
  • Ensure that functional leads perceive and can use the TMF as an ongoing study tool
  • Account for business process needs through a suitable eTMF configuration
  • Study how eTMF at Regeneron is used as an ongoing study tool

Jason WeinsteinBusiness Lead for eTMFREGENERON

4:15PM

Case Study Hear AbbVie’s Business System Operation Support (BSOS) — Experience Implementing and Ramping up an eTMF System
  • Design and implement “Authorization to Release” tools
  • Provide necessary training and support for all users
  • Listen to best practices for Full Document Processing
  • Discuss challenges of moving from seven studies to using eTMF for “all” studies within AbbVie in 3 years!

Susan Boyer YoungBusiness Systems Operation SupportABBVIE
Case Study Enhance Quality and Improve Inspection Readiness by Supporting and Allying With Internal Partners for In-House Studies
  • Survey the roadmap of your study to determine what tools and measurements you will need
  • Evaluate the health of your TMF using strategic metrics to measure select (i.e. the most critical) facets of your TMF
  • Inspect a process of customizing a tool to conduct a milestones review
  • Reallocate or redirect resources to better collaborate with different functions
  • Compare and contrast the contents of Master Allergan’s TMF Archive Directory of Record tool for disparate studies
  • Look at one TMF team's evolution over time in terms of composition and attributes

Renee FateDirector, Clinical Records ManagementALLERGAN

5:00PM Networking Reception

6:00PM Day One Concludes

 

Conference Day Two | Thursday, January 18, 2018 

Strategy 

Operations 

Partners 

8:00AM

Registration and Continental Breakfast Begin

8:30AM

Co-Chair’s Recap Day One
Karen RoySenior Vice President, Client SolutionsPHLEXGLOBAL
Co-Chair’s Recap Day One
Marie-Christine Poisson-CarvajalTMF Operations LeadPFIZER
Co-Chair’s Recap Day One
Jamie TothHead of TMF OperationsDAIICHI SANKYO

8:45AM

Use Software Development Methodology to Maintain Quality in Your TMF
  • Apply lessons from software development methodologies (e.g., agile, lean software) to address TMF concerns
    • Adherence to TMF standards
    • Audit readiness
    • Process improvement

Terri BakerDirector, Professional ServicesWINGSPAN TECHNOLOGY, a QuintilesIMS Company
Panel Monitor eTMF Completeness and Compliance
  • Utilize metrics to ensure a high-quality TMF is maintained
  • Determine and communicate benchmarks for meeting GCP standards
  • Hear how various companies ensure eTMF quality
  • Leverage quality metrics to conduct/orchestrate activities
  • Compare and contrast the process and criteria for determining solutions
  • Use shared metrics for your eTMF to drive improve collaboration and help organizations gauge their own performance


Ensure Compliance With Proof of Oversight Requirements of GCP R2 by Selecting CROs by Evaluating Their Abilities and Discerning Their Suitability
  • Determine telling and relevant measurements to assess risk to Quality and Compliance
  • Evaluate customer service aptitude by asking the right questions and scrutinizing answers
  • Distinguish red flags from deal breakers and discuss suitable precautions/ remedies
  • Consider risk factors when selecting a specific CRO
  • Determine effective metrics for evaluating the performance of the supplier

Lori J. RidgeClinical Project Associate Lead, Critical Document Analyst, eTMF Oversight ExpertMYLAN

9:15AM

Case Study Maintain Consistency Through M&A and Other Transitions
  • Recognize the possible impact of changes (e.g., M&A, leadership change, etc.) on quality
  • Create and implement comprehensive transition plans
  • Manage internal organization and policy changes

Brenda BrownTMF Observation LeadPFIZER
Case Study Discuss Inspection Readiness at Amgen
  • Conduct audits and address issues that arise based on what inspectors are looking for
  • Build a compliance group to lead inspections
  • Ensure GCP with active roles and controls in place
  • Examine processes for efficiency and assess their impact

Andrew WaiteDirector, Records and Information ManagementAMGEN
Panel Learn From Sites to Inform and Standardize Procedures, Provide Support and Develop Trainings
  • Provide empathetic/user-driven operations and protocols for site adherence and fidelity
  • Hear tactics for universal practices for the labeling and filing of documents
  • Prepare the site/sponsor teams along with the site/CRA/sponsor tools
  • Discuss how ICH (R2) guidelines could impact how you work with sites
  • Enhance the collection and management of Electronic Investigator Site Files (eISF) documents
  • Hear tactics and tips sites would recommend based on their stressors

Moderator:.

Alana WrigginsHead Site Management, North America, Global Site Management OperationsALLERGAN

Panelists:

Amy LounsburyManagerMINN. GASTROENTEROLOGY P.A.

10:00AM

Break

10:30AM

Set up a Successful TMF Staff
  • Rank characteristics to search for when hiring a Document Specialist.
  • Institute an Individual Development Plan program from beginning/training to autonomy
  • Harmonize TMF staff using Six Sigma tool (MSA)
  • TMF Staff management: motivating your staff
  • Discuss advantages and disadvantages of regional staff or local staff

Catharine EspanholLATAM eTMF CoordinatorBOEHRINGER INGELHEIM 
Fabio RodriguesHead of eTMF in LATAM and Clinical Operations ManagerBOEHRINGER INGELHEIM BRAZIL
Overcome Pain Points and Maintain Inspection Readiness Through Document Processing Improvements, Collection Oversight and Rolling Audits
  • Survey TMF document collection trends
  • Effect continuous collection improvements through KPI’s
  • Conduct rolling audit review of your eTMF
  • Achieve collaboration with your TMF partners
  • Discuss tactics for document mitigation

James PetersDirector of Professional ServicesDATA REDUCTION SYSTEMS CORPORATION
Case Study Work Effectively With CROs to Create a Unified TMF Process and Maintain Inspection Readiness
  • Discuss Alkermes’ consistency-driven oversight strategy for CROs and its impact on consistency
  • Institute avenues for two-way communication and collaboration among internal functions and CROs
  • Communicate expectations and support internal and external stakeholders
  • Improve internal and external processes through training and support
  • Discuss the lessons learned from working with a broad array of CROs of disparate cultures and needs

Kate SantoroClinical Trial Manager, Clinical Systems and DocumentationALKERMES

11:00AM

Panel Coordinate to Collaborate: How CROs and Sites Can Become Partners
  • Vet CROs using poignant and objective criteria and evaluate their risk quotient and partner suitability
  • Determine telling and relevant measurements to assess risk to quality and compliance
  • Ascertain capability by adapting a rating system for cultural fit and aptitudes
  • Evaluate customer service aptitude by asking the right questions and scrutinizing answers
  • Explore the advantages of KPI-driven partnerships

Panelists:

Joanne MaliaAssociate Director, Clinical Documentation ManagementREGENERON


Panel Compare the Merits and Drawbacks of eTMF vs Email Communication
  • Avoid findings from MHRA, EMA, and the FDA when they are checking correspondence in your eTMF
  • Organize emails into topics in your eTMF and prioritize email correspondence
  • Turn email into a productivity ally and not a time waster
  • Hear tips and etiquette that can help you in the use of emails


Maintain Consistency Through Mergers and Acquisitions and Other Transformations and Transitions at CROs
  • Create and implement comprehensive transition plans
  • Manage internal organization and policy changes
  • Develop a communication plan suited to relating to the various internal departments and external partners with disparate needs
  • Maintain continuity throughout
 

11:30AM

Effect eTMF Quality by Providing Essential Training and Support
  • Communicate, clarify, and uphold expectations for sponsor and CRO eTMF user
  • Conduct performance-based training simulations in person and remotely
  • Explore metrics for user performance assessments and thresholds for interventions or additional training
  • Survey various training tools and how they are customized
  • Execute validations and make necessary changes to script
  • Partner with HR to ensure that suitable candidates are selected based on informed criteria

Dina AntonacciClinical Training and Systems ManagerMALLINCKRODT
Fortify Quality Control With an Inspection-Ready Mindset for TMF Quality Assurance
  • Highlight the instrumental practices for instilling and inspection-ready mindset
  • Solve problems in your organization via a multidisciplinary approach
  • Communicate QC reasoning and standards to ensure compliant document filing and maintenance sponsor companies
  • Provide comprehensive feedback to TMF users
  • Standardize metadata and examine your improved workflow
  • Use systems to their potential for efficient retrieval of inspection documents

Evelin BaezClinical Document Management SpecialistCR BARD
Determine the Degree of Correlation or Dissociation of eSignatures to Essential Documents
  • Discuss the trends in the adoption and use of eSignatures by sponsors, CROs and sites
  • Prepare for inspection of eSignatures and disse ct the technology that enables them
  • Examine the impact of new regulations and guidance on essential documents and regulated content management systems
  • Discover and compare variations in technology models, from the Chevy to the Cadillac

Betsy FallenSpecial Topics ConsultantSAFE-BIOPHARMA ASSOCIATION

12:00PM

Luncheon

1:00PM

Advance Your Inspection Readiness With Analysis of Trends Trending for Effective Oversight of CRO TMF Management
  • Evaluat e of TMF for inspection readiness using customized tools
  • Extract metrics and prioritization of corrective action
  • Analyze to determine trends for process improvement and development
  • Consider the impact of new or pending regulations on TMF management

Mark ChoeTMF Quality Management and Inspection Readiness ConsultantDAIICHI SANKYO

1:45PM

Prepare for a TMF Inspection — Follow the Trends and Remain Compliant
  • Evaluate e of TMF for inspection readiness using customized tools
  • Extract metrics and prioritization of corrective action
  • Analyze to determine trends for process improvement and development
  • Consider the impact of new or pending regulations on TMF management

Laura NaranjoTMF Operations, Clinical Development Operations FunctionDAIICHI SANKYO

2:30PM

Break

3:00PM

Manage Email Correspondence Within the Trial Master File
  • Address what email correspondences need to be put within the TMF
  • Learn how to file a large number of emails sent between sponsors, CROs and investigators
  • Develop strategies and guidances for filing emails
  • Utilize technology to enhance and integrate filing within an eTMF
  • Explore best practices for handling email attachments
 

3:45PM

Case Study Holistic Approach for Achieving Quality – Inspection Ready TMFs
  • Discuss the impact of ICH E6 (R2) on TMF quality and quantity
  • Identify strategies to evaluate and mitigate TMF compliance risks
  • Establish quality standards, metrics and tools to keep TMFs accurate and current
  • Identify and limit risk in accordance with common inspection findings
  • Minimize risk through effective change management and education

Jennifer PoulakosDirector, Development Quality AssuranceAGENSYS, an affiliate of ASTELLAS

4:30PM

Conference Concludes

 

 

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Faculty
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Karen graduated as a pharmacist in South Africa and entered the life science industry working for Eli Lilly. In 1992, she moved into clinical research in the UK with Chiltern International, initially managing the Clinical Development Department across Europe. Latterly she started and globally managed a novel group, EDC Solutions.

In 2007, Karen joined Phlexglobal as Chief Business Development Officer and moved into her current role as Senior Vice President, Client Solutions in 2015. With her clinical and EDC background, Karen has also taken on a lead role in Phlexglobal’s electronic Trial Master File initiative, to promote, develop and implement support of Client eTMF systems as well as Phlexglobal’s eTMF Solution – PhlexEview.

Karen also co-chairs the DIA TMF Reference Model, an industry-driven initiative to standardize the content, naming and structure of Trial Master Files.

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Karen graduated as a pharmacist in South Africa and entered the life science industry working for Eli Lilly. In 1992, she moved into clinical research in the UK with Chiltern International, initially managing the Clinical Development Department across Europe. Latterly she started and globally managed a novel group, EDC Solutions.

In 2007, Karen joined Phlexglobal as Chief Business Development Officer and moved into her current role as Senior Vice President, Client Solutions in 2015. With her clinical and EDC background, Karen has also taken on a lead role in Phlexglobal’s electronic Trial Master File initiative, to promote, develop and implement support of Client eTMF systems as well as Phlexglobal’s eTMF Solution – PhlexEview.

Karen also co-chairs the DIA TMF Reference Model, an industry-driven initiative to standardize the content, naming and structure of Trial Master Files.

">

Karen graduated as a pharmacist in South Africa and entered the life science industry working for Eli Lilly. In 1992, she moved into clinical research in the UK with Chiltern International, initially managing the Clinical Development Department across Europe. Latterly she started and globally managed a novel group, EDC Solutions.

In 2007, Karen joined Phlexglobal as Chief Business Development Officer and moved into her current role as Senior Vice President, Client Solutions in 2015. With her clinical and EDC background, Karen has also taken on a lead role in Phlexglobal’s electronic Trial Master File initiative, to promote, develop and implement support of Client eTMF systems as well as Phlexglobal’s eTMF Solution – PhlexEview.

Karen also co-chairs the DIA TMF Reference Model, an industry-driven initiative to standardize the content, naming and structure of Trial Master Files.

">

Sharon Ames

Director, Client Solutions 
PHLEXGLOBAL

Sharon Ames is Director, Client Solutions for Phlexglobal. Sharon is an industry leader in Trial Master File and electronic Trial Master File management. With more than 25 years of experience in the clinical research industry, Sharon has extensive knowledge of clinical trial processes and cross functional relationships as they relate to essential document requirements during the conduct of clinical trials.

As a Registered Dietitian, Sharon began her clinical career at the Metabolic and Atherosclerosis Research Center in Cincinnati, Ohio. In 2011 her clinical experience expanded to Kendle International, now INC Research. During this time Sharon held many clinical leadership roles in project management and global TMF management as well as for study/site start-up activities. Her more recent experience is with eTMF system implementations and integrations in the vendor space.

Sharon is an active member of both the TMF Reference Model group and the TMF Reference Model Steering Committee.

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Sharon Ames is Director, Client Solutions for Phlexglobal. Sharon is an industry leader in Trial Master File and electronic Trial Master File management. With more than 25 years of experience in the clinical research industry, Sharon has extensive knowledge of clinical trial processes and cross functional relationships as they relate to essential document requirements during the conduct of clinical trials.

As a Registered Dietitian, Sharon began her clinical career at the Metabolic and Atherosclerosis Research Center in Cincinnati, Ohio. In 2011 her clinical experience expanded to Kendle International, now INC Research. During this time Sharon held many clinical leadership roles in project management and global TMF management as well as for study/site start-up activities. Her more recent experience is with eTMF system implementations and integrations in the vendor space.

Sharon is an active member of both the TMF Reference Model group and the TMF Reference Model Steering Committee.

">

Sharon Ames is Director, Client Solutions for Phlexglobal. Sharon is an industry leader in Trial Master File and electronic Trial Master File management. With more than 25 years of experience in the clinical research industry, Sharon has extensive knowledge of clinical trial processes and cross functional relationships as they relate to essential document requirements during the conduct of clinical trials.

As a Registered Dietitian, Sharon began her clinical career at the Metabolic and Atherosclerosis Research Center in Cincinnati, Ohio. In 2011 her clinical experience expanded to Kendle International, now INC Research. During this time Sharon held many clinical leadership roles in project management and global TMF management as well as for study/site start-up activities. Her more recent experience is with eTMF system implementations and integrations in the vendor space.

Sharon is an active member of both the TMF Reference Model group and the TMF Reference Model Steering Committee.

">Speaker Profile

Dina Antonacci

Clinical Training and Systems Manager 
MALLINCKRODT

As the Clinical Training and Systems Manager for Mallinckrodt Pharmaceuticals, Dina Antonacci leads training initiatives and clinical trial related process improvement, which included the initial implementation of the eTMF System and subsequent re-configuration and re-launch, overseeing eTMF operations and applying procedures to improve the functionality of the eTMF System, making the system more user friendly for Mallinckrodt.

Mrs. Antonacci started her career as an educator, teaching students at the college level, the fundamentals of Biology, to the details of Human Anatomy and Human Physiology. Mrs. Antonacci continues to innovate education and training practices within the Pharmaceutical industry, she has taught Medical and Laboratory Technicians how to operator and identify circulating tumor cells using tumor detecting diagnostic instrumentation. Mrs. Antonacci has achieved implementing an effective clinical onboarding program for field based Clinical Service Educators and implemented a successful training program that effectively taught Physicians and Nurses how to operate and safely deliver Photopheresis therapy to patients on two different generations of extracorporeal Photopheresis medical devices. Currently Dina drives training initiatives and is responsible for analyzing, developing, implementing, tracking, and ensuring the continuous improvement of clinical trial-related processes, systems, and SOPs.

Dina has over 11 years in the pharmaceutical industry, specializing in the field of clinical training and development for 9 of those years. Dina has a Master’s degree in the field of Neurophysiology from the University of California in Northridge, where she studied the neuro-protective effects CREB in the spastic Han-Wistar neurodegenerative rat model.

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As the Clinical Training and Systems Manager for Mallinckrodt Pharmaceuticals, Dina Antonacci leads training initiatives and clinical trial related process improvement, which included the initial implementation of the eTMF System and subsequent re-configuration and re-launch, overseeing eTMF operations and applying procedures to improve the functionality of the eTMF System, making the system more user friendly for Mallinckrodt.

Mrs. Antonacci started her career as an educator, teaching students at the college level, the fundamentals of Biology, to the details of Human Anatomy and Human Physiology. Mrs. Antonacci continues to innovate education and training practices within the Pharmaceutical industry, she has taught Medical and Laboratory Technicians how to operator and identify circulating tumor cells using tumor detecting diagnostic instrumentation. Mrs. Antonacci has achieved implementing an effective clinical onboarding program for field based Clinical Service Educators and implemented a successful training program that effectively taught Physicians and Nurses how to operate and safely deliver Photopheresis therapy to patients on two different generations of extracorporeal Photopheresis medical devices. Currently Dina drives training initiatives and is responsible for analyzing, developing, implementing, tracking, and ensuring the continuous improvement of clinical trial-related processes, systems, and SOPs.

Dina has over 11 years in the pharmaceutical industry, specializing in the field of clinical training and development for 9 of those years. Dina has a Master’s degree in the field of Neurophysiology from the University of California in Northridge, where she studied the neuro-protective effects CREB in the spastic Han-Wistar neurodegenerative rat model.

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As the Clinical Training and Systems Manager for Mallinckrodt Pharmaceuticals, Dina Antonacci leads training initiatives and clinical trial related process improvement, which included the initial implementation of the eTMF System and subsequent re-configuration and re-launch, overseeing eTMF operations and applying procedures to improve the functionality of the eTMF System, making the system more user friendly for Mallinckrodt.

Mrs. Antonacci started her career as an educator, teaching students at the college level, the fundamentals of Biology, to the details of Human Anatomy and Human Physiology. Mrs. Antonacci continues to innovate education and training practices within the Pharmaceutical industry, she has taught Medical and Laboratory Technicians how to operator and identify circulating tumor cells using tumor detecting diagnostic instrumentation. Mrs. Antonacci has achieved implementing an effective clinical onboarding program for field based Clinical Service Educators and implemented a successful training program that effectively taught Physicians and Nurses how to operate and safely deliver Photopheresis therapy to patients on two different generations of extracorporeal Photopheresis medical devices. Currently Dina drives training initiatives and is responsible for analyzing, developing, implementing, tracking, and ensuring the continuous improvement of clinical trial-related processes, systems, and SOPs.

Dina has over 11 years in the pharmaceutical industry, specializing in the field of clinical training and development for 9 of those years. Dina has a Master’s degree in the field of Neurophysiology from the University of California in Northridge, where she studied the neuro-protective effects CREB in the spastic Han-Wistar neurodegenerative rat model.

">Speaker Profile

Evelin Baez

Clinical Document Management Specialist 
CR BARD

Evelin Baez is a Clinical Management Document Specialist with more than twelve years’ experience in quality control and records management. She has been in her current position at Bard Peripheral Vascular in Tempe, Arizona for over four years. Prior to Bard, Evelin worked at Honor Health as a Data Coordinator and at Medicis Pharmaceutical as the Knowledge Management Technician. She has experience piloting the eTMF process, including conversion from paper to eTMF. Evelin currently owns twelve studies and continuously tests process efficiencies for best presentation in an audit. Evelin also participates in specialized groups for decisions regarding Clinical Operations. In addition to document management, Evelin manages investigational product inventory and accountability for new IDE trials.

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Evelin Baez is a Clinical Management Document Specialist with more than twelve years’ experience in quality control and records management. She has been in her current position at Bard Peripheral Vascular in Tempe, Arizona for over four years. Prior to Bard, Evelin worked at Honor Health as a Data Coordinator and at Medicis Pharmaceutical as the Knowledge Management Technician. She has experience piloting the eTMF process, including conversion from paper to eTMF. Evelin currently owns twelve studies and continuously tests process efficiencies for best presentation in an audit. Evelin also participates in specialized groups for decisions regarding Clinical Operations. In addition to document management, Evelin manages investigational product inventory and accountability for new IDE trials.

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Evelin Baez is a Clinical Management Document Specialist with more than twelve years’ experience in quality control and records management. She has been in her current position at Bard Peripheral Vascular in Tempe, Arizona for over four years. Prior to Bard, Evelin worked at Honor Health as a Data Coordinator and at Medicis Pharmaceutical as the Knowledge Management Technician. She has experience piloting the eTMF process, including conversion from paper to eTMF. Evelin currently owns twelve studies and continuously tests process efficiencies for best presentation in an audit. Evelin also participates in specialized groups for decisions regarding Clinical Operations. In addition to document management, Evelin manages investigational product inventory and accountability for new IDE trials.

">Speaker Profile

Terri Baker

Director, Professional Services 
WINGSPAN TECHNOLOGY

As the Director of Professional Services, Terri leads the Wingspan Business Analysis team in the elicitation and documentation of requirements (functional and user) and associated business processes for Wingspan systems. Additionally, Terri leads the Wingspan eTMF Expert Services team that supports clients in the use of the Wingspan eTMF. This includes the creation of the list of required documents for study, maintenance of the list of required documents, and filing and quality control of the documents submitted to the TMF.

Terri graduated from Washington University in St. Louis with a BS in Biomedical Engineering. She also has a MBA with a concentration in Pharmaceutical Management from the Fox School of Business at Temple University and over 15 years of Health Sciences and Health Sciences IT related experience.

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As the Director of Professional Services, Terri leads the Wingspan Business Analysis team in the elicitation and documentation of requirements (functional and user) and associated business processes for Wingspan systems. Additionally, Terri leads the Wingspan eTMF Expert Services team that supports clients in the use of the Wingspan eTMF. This includes the creation of the list of required documents for study, maintenance of the list of required documents, and filing and quality control of the documents submitted to the TMF.

Terri graduated from Washington University in St. Louis with a BS in Biomedical Engineering. She also has a MBA with a concentration in Pharmaceutical Management from the Fox School of Business at Temple University and over 15 years of Health Sciences and Health Sciences IT related experience.

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As the Director of Professional Services, Terri leads the Wingspan Business Analysis team in the elicitation and documentation of requirements (functional and user) and associated business processes for Wingspan systems. Additionally, Terri leads the Wingspan eTMF Expert Services team that supports clients in the use of the Wingspan eTMF. This includes the creation of the list of required documents for study, maintenance of the list of required documents, and filing and quality control of the documents submitted to the TMF.

Terri graduated from Washington University in St. Louis with a BS in Biomedical Engineering. She also has a MBA with a concentration in Pharmaceutical Management from the Fox School of Business at Temple University and over 15 years of Health Sciences and Health Sciences IT related experience.

">Speaker Profile

Brenda Brown

TMF Observation Lead 
PFIZER

Brenda R. Brown of Pfizer has been in her current position since November 2011 as the TMF Business Support and CAPA Management Lead. She has broad familiarity leading efforts to manage cross-organizational collaboration to support study TMF transition and to ensure inspection readiness in supporting clinical project teams with records management and compliance issues. Additionally, she has extensive experience and knowledge integrating electronic and paper TMFs associated with acquisitions, collaborations and divestitures (ACDs).

Brenda joined Pfizer in 1988 and her experience spans many aspects of drug development. She has worked in the clinical and development operations arenas through much of her career, with accountability for supporting senior management, business operations, global resourcing and other clinical trial management activities. She earned her Bachelor of Science degree in business administration with a minor in accounting, and an MBA from the University of New Haven.

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Brenda R. Brown of Pfizer has been in her current position since November 2011 as the TMF Business Support and CAPA Management Lead. She has broad familiarity leading efforts to manage cross-organizational collaboration to support study TMF transition and to ensure inspection readiness in supporting clinical project teams with records management and compliance issues. Additionally, she has extensive experience and knowledge integrating electronic and paper TMFs associated with acquisitions, collaborations and divestitures (ACDs).

Brenda joined Pfizer in 1988 and her experience spans many aspects of drug development. She has worked in the clinical and development operations arenas through much of her career, with accountability for supporting senior management, business operations, global resourcing and other clinical trial management activities. She earned her Bachelor of Science degree in business administration with a minor in accounting, and an MBA from the University of New Haven.

">

Brenda R. Brown of Pfizer has been in her current position since November 2011 as the TMF Business Support and CAPA Management Lead. She has broad familiarity leading efforts to manage cross-organizational collaboration to support study TMF transition and to ensure inspection readiness in supporting clinical project teams with records management and compliance issues. Additionally, she has extensive experience and knowledge integrating electronic and paper TMFs associated with acquisitions, collaborations and divestitures (ACDs).

Brenda joined Pfizer in 1988 and her experience spans many aspects of drug development. She has worked in the clinical and development operations arenas through much of her career, with accountability for supporting senior management, business operations, global resourcing and other clinical trial management activities. She earned her Bachelor of Science degree in business administration with a minor in accounting, and an MBA from the University of New Haven.

">Speaker Profile

Mark Choe

TMF Quality Management and Inspection Readiness Consultant 
DAIICHI SANKYO

Mark is an Inspection Readiness Consultant at Daiichi Sankyo where he plies his experience conducting inspections for coaching and audit preparation His responsibilities also include conducting gap analysis of study documentation Process review of taxonomy and document life cycle.
His two decades of experience in clinical operation, business process management, agency audit preparation, and document management gives him an in-depth and granular understanding of eCTD development.

Mark currently serves as faculty for the RAPS advanced eCTD program.


In his capacity of partner at auCONCORDIA, Mark, is a SharePoint developer who has created a cloud application that manages Common Technical Document development from authoring to validation and agency submission. Mark uses a state of the art interactive eLearning system with compliance and competency tracking to maximize training efficacy and adoption.

">

Mark is an Inspection Readiness Consultant at Daiichi Sankyo where he plies his experience conducting inspections for coaching and audit preparation His responsibilities also include conducting gap analysis of study documentation Process review of taxonomy and document life cycle.
His two decades of experience in clinical operation, business process management, agency audit preparation, and document management gives him an in-depth and granular understanding of eCTD development.

Mark currently serves as faculty for the RAPS advanced eCTD program.


In his capacity of partner at auCONCORDIA, Mark, is a SharePoint developer who has created a cloud application that manages Common Technical Document development from authoring to validation and agency submission. Mark uses a state of the art interactive eLearning system with compliance and competency tracking to maximize training efficacy and adoption.

">

Mark is an Inspection Readiness Consultant at Daiichi Sankyo where he plies his experience conducting inspections for coaching and audit preparation His responsibilities also include conducting gap analysis of study documentation Process review of taxonomy and document life cycle.
His two decades of experience in clinical operation, business process management, agency audit preparation, and document management gives him an in-depth and granular understanding of eCTD development.

Mark currently serves as faculty for the RAPS advanced eCTD program.


In his capacity of partner at auCONCORDIA, Mark, is a SharePoint developer who has created a cloud application that manages Common Technical Document development from authoring to validation and agency submission. Mark uses a state of the art interactive eLearning system with compliance and competency tracking to maximize training efficacy and adoption.

">Speaker Profile

Grace Crawford

VP Clinical Quality and Compliance 
MedImmune

Grace joined MedImmune in April 2015 as head of the Clinical Quality and Compliance function responsible for the Quality Management Framework that supports Clinical Biologics. Prior to joining MedImmune, Grace spent more than 21 years at ICON where her main focus was leading the Clinical Quality Assurance Department. She is active in the industry, participating in forums such as the Society for Quality Assurance, the AVOCA Quality Consortium and the Linking Leaders Clinical “Quality” Roundtable. Before joining ICON, Grace was a medical technologist in the Clinical Laboratory (Special Chemistry and Immunology) at Bryn Mawr Hospital in Pennsylvania. She earned a Master of Science in clinical microbiology at The Medical College of Pennsylvania.

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Grace joined MedImmune in April 2015 as head of the Clinical Quality and Compliance function responsible for the Quality Management Framework that supports Clinical Biologics. Prior to joining MedImmune, Grace spent more than 21 years at ICON where her main focus was leading the Clinical Quality Assurance Department. She is active in the industry, participating in forums such as the Society for Quality Assurance, the AVOCA Quality Consortium and the Linking Leaders Clinical “Quality” Roundtable. Before joining ICON, Grace was a medical technologist in the Clinical Laboratory (Special Chemistry and Immunology) at Bryn Mawr Hospital in Pennsylvania. She earned a Master of Science in clinical microbiology at The Medical College of Pennsylvania.

">

Grace joined MedImmune in April 2015 as head of the Clinical Quality and Compliance function responsible for the Quality Management Framework that supports Clinical Biologics. Prior to joining MedImmune, Grace spent more than 21 years at ICON where her main focus was leading the Clinical Quality Assurance Department. She is active in the industry, participating in forums such as the Society for Quality Assurance, the AVOCA Quality Consortium and the Linking Leaders Clinical “Quality” Roundtable. Before joining ICON, Grace was a medical technologist in the Clinical Laboratory (Special Chemistry and Immunology) at Bryn Mawr Hospital in Pennsylvania. She earned a Master of Science in clinical microbiology at The Medical College of Pennsylvania.

">Speaker Profile

Mike Czaplicki

Clinical Documentation Operations Manager 
GSK

Mike Czaplicki is a Clinical Documentation Operations Manager in the Quality and Risk Management department of GSK’s Pharmaceutical R&D division. Mike is part of a core team that is leading the implementation of an eTMF system across Pharma R&D at GSK and is responsible for a matrix team that maintains the GSK Pharma mapping to the TMF Reference Model and TMF Plan templates. Mike also is a member of the TMF Reference Model Steering Committee and a leading an effort to deliver an updated User Guide and Implementation Toolkit. Prior to working on eTMF Implementation, Mike worked as a Business Analyst for the Records Management Archive Group at GSK and an Information Management Associate at Merck.

Mike holds a Master of Science in Quality Assurance and Regulatory Affairs from Temple University, as well as a Bachelor of Science in Biology.

">

Mike Czaplicki is a Clinical Documentation Operations Manager in the Quality and Risk Management department of GSK’s Pharmaceutical R&D division. Mike is part of a core team that is leading the implementation of an eTMF system across Pharma R&D at GSK and is responsible for a matrix team that maintains the GSK Pharma mapping to the TMF Reference Model and TMF Plan templates. Mike also is a member of the TMF Reference Model Steering Committee and a leading an effort to deliver an updated User Guide and Implementation Toolkit. Prior to working on eTMF Implementation, Mike worked as a Business Analyst for the Records Management Archive Group at GSK and an Information Management Associate at Merck.

Mike holds a Master of Science in Quality Assurance and Regulatory Affairs from Temple University, as well as a Bachelor of Science in Biology.

">

Mike Czaplicki is a Clinical Documentation Operations Manager in the Quality and Risk Management department of GSK’s Pharmaceutical R&D division. Mike is part of a core team that is leading the implementation of an eTMF system across Pharma R&D at GSK and is responsible for a matrix team that maintains the GSK Pharma mapping to the TMF Reference Model and TMF Plan templates. Mike also is a member of the TMF Reference Model Steering Committee and a leading an effort to deliver an updated User Guide and Implementation Toolkit. Prior to working on eTMF Implementation, Mike worked as a Business Analyst for the Records Management Archive Group at GSK and an Information Management Associate at Merck.

Mike holds a Master of Science in Quality Assurance and Regulatory Affairs from Temple University, as well as a Bachelor of Science in Biology.

">Speaker Profile

Martina Duevel

Senior Global Clinical Project Manager 
BAYER PHARMACEUTICALS

Martina Duevel joined the pharmaceutical industry seventeen years ago working first in the Clinical Quality Assurance department at Schering AG in Berlin and then in clinical project management at Bayer. In January 2015, she was assigned as Clinical Project Leader for eTMF implementation and maturation. She has a bachelors degree in biochemistry and a Ph.D. in the natural sciences.

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Martina Duevel joined the pharmaceutical industry seventeen years ago working first in the Clinical Quality Assurance department at Schering AG in Berlin and then in clinical project management at Bayer. In January 2015, she was assigned as Clinical Project Leader for eTMF implementation and maturation. She has a bachelors degree in biochemistry and a Ph.D. in the natural sciences.

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Martina Duevel joined the pharmaceutical industry seventeen years ago working first in the Clinical Quality Assurance department at Schering AG in Berlin and then in clinical project management at Bayer. In January 2015, she was assigned as Clinical Project Leader for eTMF implementation and maturation. She has a bachelors degree in biochemistry and a Ph.D. in the natural sciences.

">Speaker Profile

Sholeh Ehdaivand

President and CEO 
LMK CLINICAL RESEARCH CONSULTING

Sholeh is President and CEO of LMK Clinical Research Consulting, a certified women-owned TMF consulting and services company. She is also the Facilitator of the Metric Champion Consortium’s (MCC) TMF initiative; a cross-industry working group defining standard metrics and key risk indicators that support the TMF. She is recognized as an innovative professional with over 15 successful years of experience in the Clinical Research Industry. Her expertise and knowledge in all areas of study management and operational aspects of the clinical trial and document management processes has made her a leader and trusted expert. Her experience includes the TMF reference model member, eTMF management, domestic and international pharmaceutical and biological clinical trials, clinical trial management, site selection, vendor relations/CRO management, electronic document management, regulatory submissions, quality control processes and implementation, IRB communications, and regulatory inspection participation and preparation. When she is not consulting on TMFs, she enjoys spending quality time with her family.

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Sholeh is President and CEO of LMK Clinical Research Consulting, a certified women-owned TMF consulting and services company. She is also the Facilitator of the Metric Champion Consortium’s (MCC) TMF initiative; a cross-industry working group defining standard metrics and key risk indicators that support the TMF. She is recognized as an innovative professional with over 15 successful years of experience in the Clinical Research Industry. Her expertise and knowledge in all areas of study management and operational aspects of the clinical trial and document management processes has made her a leader and trusted expert. Her experience includes the TMF reference model member, eTMF management, domestic and international pharmaceutical and biological clinical trials, clinical trial management, site selection, vendor relations/CRO management, electronic document management, regulatory submissions, quality control processes and implementation, IRB communications, and regulatory inspection participation and preparation. When she is not consulting on TMFs, she enjoys spending quality time with her family.

">

Sholeh is President and CEO of LMK Clinical Research Consulting, a certified women-owned TMF consulting and services company. She is also the Facilitator of the Metric Champion Consortium’s (MCC) TMF initiative; a cross-industry working group defining standard metrics and key risk indicators that support the TMF. She is recognized as an innovative professional with over 15 successful years of experience in the Clinical Research Industry. Her expertise and knowledge in all areas of study management and operational aspects of the clinical trial and document management processes has made her a leader and trusted expert. Her

JOA171219CEV
 

 


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Keywords: fun, analysis, administration , analyze, architecture , assessment , audience, biology , business , Clinical




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