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Join us for Innovation Tour:

A Journey through  the World of Clinical and Regulatory Innovation

 

Bringing together industry experts to discuss clinical and regulatory related topics and explore innovative approaches. 

Innovation Tour is an exciting new concept in virtual events. Over the next several months, you will have the opportunity to join Life Science Industry experts for a series of live and on demand sessions focused on innovative ideas in Clinical and Regulatory Solutions. There will be at least one session every week, and a single registration form gives you total access. Plus, the more you participate, the more chances you have to win great rewards. 

 

BROUGHT TO YOU BY PHLEXGLOBAL AND COMPANIONS

 

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Innovation Tour is your Opportunity to...

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LEARN

Gain the latest information on hot industry topics

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NETWORK

Network with your peers and learn exciting new ideas 

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SHARE

Voice your opinion and share your thoughts 

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WIN

Earn points for participating and win fabulous prizes

 

 

 

 

 

 

 

 

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Upcoming Live Sessions

 

IT2020_12DEC_09 Prepating for 2021

Preparing for 2021: COVID, Clinical, Regulatory and more

December 9th, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

As we prepare to put 2020 behind us, our team of experts will look at some of the important changes this history year has brought to the Life Sciences industry.

This session will include a look forward to such topics as the changing regulations taking effect in 2021, the role of virtual inspections, the rise of remote monitoring, navigating this updates in a GDPR world, and the FDA's update on eCTD.

 

 

Register for Innovation Tour

Prior Tour Stops - Now Available On Demand

survey

Innovation Tour Survey Results Panel: Future Trends in TMF, IDMP, and eCTD

October 29th, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

Throughout the Innovation Tour, participants have contributed their opinions to three survey topics: the eTMF Exchange Mechanism Standard, the IDMP Implementation Guide Version 1, and China's Readiness for eCTD.

The surveys are closed, and the results are in!

This session will take a deep dive into the results explore the future impact. 

 

On Demand

 

IT2020_09OCT_14 Overcoming TMF Managment Challenges Faced by Small and Mid-sized Companies

Overcoming TMF Management Challenges Faced by Small and Mid-Sized Companies

October 14th, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

Maintaining an inspection-ready Trial Master File is becoming increasingly burdensome, even for teams with significant resources.

For small and mid-sized sponsors, however - with resources often stretched across managing the study as well as the Trial Master File – achieving ongoing TMF quality, completeness, and timeliness can be an overwhelming task. And while outsourcing some aspects of the TMF can help, that in turn creates its own set of challenges.

In this session, our experts will walk through a new, full-service TMF management approach implemented by smaller biopharmaceutical companies. By adopting a fixed-fee, turnkey model encompassing everything required for ongoing TMF health, these organizations are achieving high-quality TMF compliance – with far less effort.

On Demand

 

IT2020_10OCT_07 TMF Audit Trail

Taking a Risk-Based Approach to an Inspection-Ready Audit Trail

October 7th, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

Regulatory agencies agree that a risk-based approach is the best way to ensure quality in clinical trials. But knowing how to implement such a process can be daunting. In this session, we will explore how to implement RBM to ensure your TMF Audit Trail is ready for inspection.

We will cover the following topics:

  • Understanding the requirements for audit trails
  • How to look through all the actions and find what you are looking for
  • Ways to follow your process and compare the audit trail
  • How to document or show evidence of review
On Demand

 

IT2020_09SEP_23 Solving the eMail Problem

Solving the eMail Problem: Automating Correspondence Classification in the TMF

September 23rd, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

Email correspondence represents one of the greatest challenges to building a complete Trial Master File.

This is a serious problem facing clinical trial sponsors, as it is difficult to capture all email correspondence and to classify it properly within the TMF.

In this session, we will discuss this problem from a compliance perspective and explore the TMF Reference Models correspondence guidance. 

The session will also feature a case study from Chiesi, discussing the problems they were facing and how a pilot study using Phlexglobal Artificial Intelligence helped with eMail classification. 

On Demand

 

IT2020_09SEP_16 Quality by Design

QbD: Should Operational Audit Readiness be Defined as ACA+C?

September 16th, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

Clinical research professionals have an obligation to uphold the highest ethical standards and strive for compliance with Good Clinical Practice (GCP). The ALCOA+C definition in ICH E6(R2) has created challenges and uncertainty within the industry with regard to its implementation in a TMF.

Fundamental to these new guidelines is the modernization of processes and technology to clinical trials with a focus on Quality by Design and risk-based management approaches that emphasize operational efficiencies and a movement away from an overreliance on retrospective practices.

But, do “L” legible and “O” original, key components of the ALCOA+C guidance, and other quality attributes, prevent “C” contemporaneous in an operational TMF?

In this session we will explore:

  • How a focus on an operational TMF will ensure QbD
  • How contemporaneous can be defined in operational SOPs
  • How contemporariness can be implemented in daily operations
  • How to measure and document contemporariness
  • Ensure audit readiness with regards to contemporariness

On Demand

 

IT2020_09SEP_09 Panel Discussion Innovative Approaches and Best Practices for TMF Management

Panel Discussion: Innovative Approaches and Best Practices for TMF Management 

September 9th, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

Bringing together some of the best minds in Trial Master File management, this panel discussion will explore a variety of topics and ideas with a single focus: helping you achieve TMF Health.

Plus bring your ideas to this session for a chance to win points towards our Innovation Tour rewards!

On Demand

IT2020_08AUG_26 The Journey from File to Trial Automating Regulatory to TMF

The Journey from File to Trial: Automating Regulatory to TMF

Explore the value of automation between the Trial Master File (TMF) and Regulatory solutions. This connection can bridge the gap from the clinical trial to the regulatory filing, ensuring consistency of information while reducing duplicated data entry.

 

On Demand

 

IT2020_08AUG_19 TMF Outsourcing Fitting the Model to the Sponsor Model

TMF Outsourcing
Fitting the Model to the Sponsor Model

August 19, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

There is no disputing the fact that Trial Master File Health is a vital part of drug development. And while there is no singular model for managing a TMF, it is also an undeniable fact that expert TMF support can plan an import role for any organization.

In this session, we explore the advantages and challenges of various TMF models such as CRO-led, Study Owners, Dedicated TMF Department and how outside, expert help can improve TMF Health in each situation.

On Demand

 

IT2020_08AUG_12 Validating an AI Solution with a Focus on Clinical and Regulatory

Validating an AI Solution with a Focus on Clinical and Regulatory

August 12, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

Artificial Intelligence is the future of technology. But how do you ensure that AI solutions will meet regulatory standards?

In this webinar our experts will review health authority recommendations (FDA, MHRA etc.) on validation of machine learning systems and discuss differences on validation methodologies for AI implementations. 


Most importantly, we will explore best practice validation techniques and walk through regulatory and clinical use cases of completed validation projects of data mining projects. 

On Demand

IT2020_08AUG_05 New Approaches to Collaborative TMF Content Management

New Approaches to Collaborative TMF Content Management

August 5, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

Collaboration is key! Trial Master File management is never a solo project. It takes the right balance of people, process, and technology to ensure your TMF meets standards for timeliness, completeness, and quality.

In this session, two of the top minds in the business will share ideas on new ways to collaborate with TMF teams to better manage content. 

On Demand

 

IT2020_07JUL_22 Trial to File to Trial Archiving Innovative Approaches to meeting Archiving UPDATED

Trial to File to Trial + Archiving:

Innovative Approaches to meeting Archiving Requirements

July 22, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

It’s not uncommon for organizations to think it is enough to create an “archive” folder on a secure network to archive their electronic data generated from a drug development project.

However, this leaves your data and organization seriously exposed. 

In this session, Arkivum and Phlexglobal will demonstrate an exciting new approach to TMF archiving that not only meets requirements, but also creates value by bringing archived data to life.

On Demand

 

IT2020_07JUL_15 Panel Discussion Innovation on IDMP Data Preparation

Panel Discussion:

Innovation on IDMP / Data Preparation

July 15th, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

IDMP (Identification of Medicinal Products) refers to a set of 5 ISO standards - ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240 – designed to standardize the structure and terminology used to describe marketed medicinal products.

In this session, our panel of experts will discuss the innovative approaches they are taking to manage this vital part of pharmaceutical commercialization. 

Topics will include ways to improve data processes across the regulatory lifecycle by utilizing advanced technologies such as AI-driven automation.

On Demand views earn 10 Award Points.

On Demand

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Our Participating Speakers

Join the leading minds in Clinical and Regulatory 

 

 

 

Blue Circle David Brindley

David Brindley

Life Science Executive
& Research Leader

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Blue Circle Steve Blanchard

Steve Blanchard

IDMP Programme Lead

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Blue Circle Janice del Rosario

Janice del Rosario

TMF Consultant

 
             
 

Blue Circle Donna Dorozinsky

Donna Dorozinsky 

President & CEO

Just in Time

 

 

 

Blue Circle Jim Horstmann

Jim Horstmann 

Product Manager 

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Blue Circle Daniel Koppers

Daniel Koppers 

Head of Research & Design 

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Blue Circle Andy Lawton 

Andy Lawton

Consultant

Risk Based Approach, Ltd

 

Blue Circle John Lazenby

John Lazenby

Technical Development Director

Phlexglobal Logo-no tagline

 

Marion Mays_blue circle

Marion Mays

Vice President, Business Development, Expert Services

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Schedule Point Coin 100

 
             
 

Blue Circle Stephanie Mayew

Stephanie Mayew

Manager of 
Clinical Operations

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Sinead McKeown

Sinead Mckeown

Vice President
Product Management

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Blue Circle Marisa Minetti

Marisa Minetti 

Head of Late Phase Clinical Administration

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Blue Circle Argha Nag

Argha Nag 

Global Regulatory Systems Data Governance Lead

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 Blue Circle Jim Nichols

Jim Nichols

Vice President, Product Management

Phlexglobal Logo-no tagline

Schedule Point Coin 100

 

Blue Circle Karen Roy

Karen Roy

Chief Strategy Officer

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Schedule Point Coin 100

 
             
 

Blue Circle Rainer Schwarz

Rainer Schwarz

Chief Marketing Officer

Phlexglobal Logo-no tagline

Schedule Point Coin 100

 

 

 Blue Circle Elvin Thalund

Elvin Thalund

Director, Industry Strategy

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Blue Circle Jamie Toth

Jamie Toth

Head of TMF Operations

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Rewards Banner

 

Earn Innovation Tour Rewards Points and Increase Your Chances of Winning Innovative Technology Prizes

Innovation Tour doesn't just expose you to exciting new ideas - it also rewards those who participate and contribute to the conversation. Participants earn points for different activities throughout the journey. The top five point earners will win their choice of a the prizes listed below. Everyone will be entered into a random drawing to win prizes as well, with one entry for each point earned!

Prizes for Top Point Earners AND Random Drawing 

Prizes 200

The Top 5 Point Earners and 5 Randomly Selected Participants will win the the prize of their choice

  • Sonos One
  • Amazon Echo Studio
  • Amazon fire HD10 with 64GB 
  • Apple AirPods
  • Jabra Elite Pure Wireless Earbud

Every Innovation Journey Point Earned Counts as one Entry

Grand Prize Drawing

Prizes 900

 

All Participants will be Entered into a Random Drawing with one lucky person winning his or her choice of 

  • Apple iPad Pro 11-inch
  • Microsoft Surface Pro 7 with 128GB 
  • Samsung Galaxy Tab S6 with 256GB 

Every Innovation Journey Point Earned Counts as one Entry

 

 

Innovation Tour Points


Point Coin 050 Register for Innovation Tour Point Coin 025 Join the Innovation Tour LinkedIn Group  
Point Coin 025 Attend a Session  Point Coin 030 Join an Excursion (small group session)  
Point Coin 020 Speak During a Session   Point Coin 050 Attend a Scheduled Demonstration  
Point Coin 010 Participate in a Session Poll Point Coin 010 Download a session white paper or graphic  
Point Coin 010 Complete a Session Survey Point Coin 100 Schedule a call with a Phlexglobal speaker  
Point Coin 010 Watch a Session On Demand  Point Coin 025 Complete an Innovation Survey

 

 

See the Leader Board! 

 

 

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Point Coin 025

Help Shape the Future! Point Coin 025
Participate in the Innovation Survey

Want to be part of the future of TMF, Regulatory, and eCTD solutions? Take our short survey to voice your opinion! You will earn 25 Reward Points for each survey you complete.

Survey Images

 

eTMF Exchange Mechanism Standard

SURVEY CLOSED!

 

Survey Images2

 

IDMP Implementation Guide v1

SURVEY CLOSED!

 

Survey Images3

 

China Readiness for eCTD

SURVEY CLOSED!

 

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One registration give you access to all events. 

 

Earn points for activities during the tour to win fabulous prizes. 

 

Receive a participation certification for each event you attend.

 

Expand your knowledge with presentation from leading Clinical and Regulatory minds.

 

Earn 50 Reward Points just  for Registering 

 

Join the Journey - Register Today!

Following your registration you will receive a series of web meeting invitations for each Innovation Tour session. You will also receive follow up messages as new sessions and events are scheduled.

Plus everyone who registers starts Innovation Tour with 50 Points!