Clinical Document World

Virtual Conference / Summit
Life Sciences Medical Devices

Date: 24 to 26 Feb '21
Time: From 9:45am (GMT-05:00) Eastern Time (US and Canada)

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Enhance your Clinical Documentation Process to ensure a complete TMF, Inspection Readiness, Quality & GCP

WHY CLINICAL DOCUMENT WORLD SHOULD BE YOUR LEARNING & NETWORKING CHOICE OF THE YEAR

Interactive educational sessions covering all aspects of clinical document management

Faculty Consisting of professionals from CROs, Sites, and sponsors with a diverse background in TMF, quality, technology, and inspections readiness

Focus on ensuring high quality documentation

Develop and maintain a culture of inspection readiness

Impact of a successful sponsor  - CRO collaboration to improve quality throughout the trial

Impact of technology to impact a clinical trial


WHO SHOULD ATTEND

Life science professionals from pharmaceuticals, biotech, and medical device organizations with responsibilities in:

  • Clinical documentation
  • Trial Master File
  • Inspection Readiness
  • Clinical Operations
  • Clinical Technology
  • Quality Assurance
  • Risk Management
  • GCP
  • Trial, Records, Document Management
  • Clinical Document Compliance
  • Clinical Trial Management
  • Clinical Innovations / Process Improvement
  • Clinical Development

SPONSORING THE SUMMIT

The Clinical Document World Event is the premier event to meet Clinical Documentation, Trial Master File, GCP, Clinical Quality professionals who are looking to improve their processes through strategic improvements and partnerships. Learn more about how we can create a unique sponsor experience for your company. Please contact Kelly Hara.

Day One


Opening Remarks

Karen Roy
Chief Strategy Officer
Phlexglobal

Wendy Trimboli
Sr. Director, Clinical Operations Process, Systems & Inspection Readiness
ACADIA Pharmaceuticals Inc.

Risk-Based Approach for Document Management

Donatella Ballerini
Document and Training Manager, Global Rare Disease R&D
Chiesi Pharmaceuticals

Innovative Use of eTMF/ Technology With a CRO (Read More)
Sharon Ames
Director Client Solutions
Phlexglobal

Stephanie Mayew
Sr Manager of Clinical Operations
PRA

Maintaining a Quality & Compliant TMF Foundation to Ensure a Successful CRO / Sponsor Relationship (Read More)


Joanne Malia
Director, Clinical Documentation Management
Regeneron

Panel: Successful Sponsor, CRO, and Site Collaboration (Read More)

Redefining Risk-Based Monitoring to Impact your Global Trials

Amy Klawitter
Director, Integrated Clinical Management
Evotec

Moving the Needle: Standardized Technical Workflows for Digitalizing Documentation Processes (Read More)


Maria Palombini
Director, Communities & Opportunities Development; Healthcare Life Sciences Practice Leader
IEEE-Standards Association


Day Two


SaaS eTMF System Validation… Is this Really Necessary?

Lisa Mulcahy
Principal Consultant
Mulcahy Consulting, LLC

➤  Align SOPs and your eTMF to Ensure Completeness

Fiona MacKenzie
Manager, TMF and Document Systems
Alnylam Pharmaceuticals

Panel: Leveraging Partnerships to Ensure your TMF is Inspection Prepared

Panel: Leveraging Emerging Technologies (Read More)

Panel: CRO, Sponsor, Site Process Alignment to Enhance TMF Management (Read More)


Day Three


Mark Choe
eTMF SME

Improving Quality by Identifying Common Issues with TMF Process and System (Read More)
Andrew Bentley
QA Manager
MiNA Therapeutics

Identify Quality Trends and Optimize Operations to Impact Documentation (Read More)
Dawn Niccum
Sr. Director, QA and Compliance
Inseption Group

➤  Supporting an Audit With Limited Resources (Read More)
Rachelle Longest
Clinical System Specialist
Smith & Nephew

TMF Validations and Oversight to Ensure Data Integrity (Read More)
Supriya Shoroff
Head of TMF Operations
AMAG Pharmaceuticals

Preparing for an Inspection by Designing and Running Mock Inspections (Read More)
Sergi Hernandez Ranzani
Clinical Quality Assurance Specialist
Grifols

Panel: Ensure Clinical Quality for all Trial Documents (Read More)

Life science professionals from pharmaceuticals, biotech, and medical device organizations.

WHAT'S INCLUDED IN MY TICKET?

Access to our virtual platform on the dates of the events which included access to all sessions and recordings, virtual networking hall, live interactions with all sessions and panels, educational atmosphere where you can interact with all speakers, sponsors, and attendees.

You will have access to the virtual event platform for 30 days after the event where you can re-watch the keynotes, spotlight sessions, and panel sessions. You will also be given a link to download the video files and PDF slides after the event.

Day One


Opening Remarks

Karen Roy
Chief Strategy Officer
Phlexglobal

Wendy Trimboli
Sr. Director, Clinical Operations Process, Systems & Inspection Readiness
ACADIA Pharmaceuticals Inc.

Risk-Based Approach for Document Management

Donatella Ballerini
Document and Training Manager, Global Rare Disease R&D
Chiesi Pharmaceuticals

Innovative Use of eTMF/ Technology With a CRO (Read More)
Sharon Ames
Director Client Solutions
Phlexglobal

Stephanie Mayew
Sr Manager of Clinical Operations
PRA

Maintaining a Quality & Compliant TMF Foundation to Ensure a Successful CRO / Sponsor Relationship (Read More)


Joanne Malia
Director, Clinical Documentation Management
Regeneron

Panel: Successful Sponsor, CRO, and Site Collaboration (Read More)

Redefining Risk-Based Monitoring to Impact your Global Trials

Amy Klawitter
Director, Integrated Clinical Management
Evotec

Moving the Needle: Standardized Technical Workflows for Digitalizing Documentation Processes (Read More)


Maria Palombini
Director, Communities & Opportunities Development; Healthcare Life Sciences Practice Leader
IEEE-Standards Association


Day Two


SaaS eTMF System Validation… Is this Really Necessary?

Lisa Mulcahy
Principal Consultant
Mulcahy Consulting, LLC

➤  Align SOPs and your eTMF to Ensure Completeness

Fiona MacKenzie
Manager, TMF and Document Systems
Alnylam Pharmaceuticals

Panel: Leveraging Partnerships to Ensure your TMF is Inspection Prepared

Panel: Leveraging Emerging Technologies (Read More)

Panel: CRO, Sponsor, Site Process Alignment to Enhance TMF Management (Read More)


Day Three


Mark Choe
eTMF SME

Improving Quality by Identifying Common Issues with TMF Process and System (Read More)
Andrew Bentley
QA Manager
MiNA Therapeutics

Identify Quality Trends and Optimize Operations to Impact Documentation (Read More)
Dawn Niccum
Sr. Director, QA and Compliance
Inseption Group

➤  Supporting an Audit With Limited Resources (Read More)
Rachelle Longest
Clinical System Specialist
Smith & Nephew

TMF Validations and Oversight to Ensure Data Integrity (Read More)
Supriya Shoroff
Head of TMF Operations
AMAG Pharmaceuticals

Preparing for an Inspection by Designing and Running Mock Inspections (Read More)
Sergi Hernandez Ranzani
Clinical Quality Assurance Specialist
Grifols

Panel: Ensure Clinical Quality for all Trial Documents (Read More)

Life science professionals from pharmaceuticals, biotech, and medical device organizations.

WHAT'S INCLUDED IN MY TICKET?

Access to our virtual platform on the dates of the events which included access to all sessions and recordings, virtual networking hall, live interactions with all sessions and panels, educational atmosphere where you can interact with all speakers, sponsors, and attendees.

You will have access to the virtual event platform for 30 days after the event where you can re-watch the keynotes, spotlight sessions, and panel sessions. You will also be given a link to download the video files and PDF slides after the event.

Stay Updated

Organizer

Lincoln Health Network

Stay Updated

Organizer

Lincoln Health Network

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