Join us for Innovation Tour:

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. 

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.

The Journey from File to Trial: Automating Regulatory to TMF

August 26, 2020
10am Eastern / 3pm GMT / 4pm Central Europe

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.

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!

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. 

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.

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.