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The Rundown: ExL’s Blog

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TMF Summit Recap and 2019 Preview!

ExL Events’ recent Trial Master File (TMF) Summit received a great recap from TransPerfect over at Clinical Leader in the article titled TMF Summit 2018: Achieving Real-Time Agility. 

In this article, the following TMF Summit topics were shared:

Opportunities for new attendees
The importance of prioritizing training
Effectively capturing study correspondence
Effective TMF management requires thoughtful engagement
Mind your GDPR (General Data Protection Regulation)
Establish clear data retention strategy and policy
The ole’ Regulatory Binder (or eISF)
A growing conference for a growing professional community

You can learn more about the TMF Summit’s…


Pfizer in Hot Water With FDA Over ESTRING Ad

A recent advertisement for Pfizer’s new hormonal therapy for postmenopausal patients, Estring, caught the attention of the FDA’s Office of Prescription Drug Promotion in a bad way. In this direct-to-consumer promotion, spokespeople for Estring, depicted in the ad as doctor and patient, discuss the new treatment, with the patient proclaiming that she had suffered no side effects. Unfortunately for Pfizer, any plausible side effects must be brought to the attention of consumers, even if this particular case showed none. This resulted in a chastising letter for Pfizer.

Though Pfizer might not agree, this story…


Where AI Is Headed in Healthcare: A Post-Event Article From PM360

ExL Events is humbled to share a great new post-event article from our media partners, PM360, titled “Where is AI in Healthcare Headed and Other Learnings from Recent AI Summit.” The topic of this article is our recent AI Innovations for Life Science and Healthcare Summit, which took place June 13–14 in Philadelphia.

This article touches on the following pressing topics in AI and healthcare:
Watson Woes
Two Steps Forward, Three Steps Back
One Step Forward, Another Step Forward
A Brave (but Prudent) New World
Breaking Good
Real-World Artificial Intelligence
Artificial Intelligence by any Other Name is Actually Less Scary
Patient-centered Blockchain



ExL Events is excited to announce that MASS West 2018 will be taking place September 24–26 at the San Diego Marriott Del Mar in San Diego!

The Medical Affairs Strategic Summit (MASS) West is a two-tracked event that provides a holistic view of medical affairs. It features case studies, panel discussions and strategic insights from medical affairs leadership and MSLs responsible for developing and managing launch preparations, medical strategy, scientific communications, investigator-initiated trials, publication planning, medical information and more.

Click here for an advance copy of the brochure.

With a wide range of content, this event gives you the opportunity to…


7th Clinical Trials Inspection Readiness Summit Early Bird Pricing Ends Soon!

The 7th Clinical Trials Inspection Readiness Summit’s Early Bird pricing rates expire on Friday, June 29. Register now to take advantage of our lowest prices available. Please be sure to mention Priority Code 789118BLOG when signing up.

Inspection Readiness is not just about being prepared when an inspector walks through the door but developing, improving, and understanding a company’s culture of inspection readiness. This culture not only is meaningful for the sponsor, but for all vendors utilized during the trial. There is still time to join your colleagues who have already reserved their seat for the 7th Clinical Trials Inspection…



ExL Events is excited to announce the agenda for the Collaborations Addressing Vulnerable Populations (CAVP) Forum taking place on October 16–17 at the Hilton Washington Dulles Airport in Herndon, VA. This four-track forum is designed for organizations that support the discovery and development of treatments for underserved and neglected patient populations.

Download the brochure today!

Attendees will have the opportunity to tailor their educational experience and attend sessions from the following four tracks:

– Priority Review Voucher Track
The only platform to dissect the benefits and challenges of developing a drug that would be eligible for a PRV.

– Strategic Partnerships for…


Artificial Intelligence and the Use of Technology to Support Medical Writing

From structured content authoring to the use of AI platforms, the 5th Clinical Regulatory Medical Writing Forum will discuss where medical writing groups can leverage innovative tools to improve the efficiency of their writing capabilities. Join your peers in Philadelphia on July 12–13 to learn about key areas where the implementation of AI can reduce redundancy and streamline content generation in regulatory writing.
Featured AI Sessions
Technology-Driven Approaches to Supporting the Creation/Production of Different Clinical and/or Regulatory Documents
Madhavi Gidh-Jain, Ph.D., Senior Director, Head Medical Writing (U.S.), SANOFI

Writing for the Future: Reduce, Reuse, Recycle
Lawrence Giraudi, Manager,…


Save the Date: Life Science Administrative Excellence Forum, November 28–29

Administrative professionals are an essential part of the support system for the leadership of any life science organization. These business members add value to their company through strategic internal and external communication on behalf of their leadership.

As more pharmaceutical and biotechnology companies grow to meet medical needs on a global scale, the role of the administrative professional has never been more critical and vital than in today’s dynamic drug development sector. This is why ExL Events is excited to deliver the Life Science Administrative Excellence Forum, taking place November 28–29 in Florham Park, NJ.

Featured Sessions

Make the Transition From Admin Pool…


Humana and AstraZeneca Balance the AI & Blockchain Hype With Practical Use Cases

AI Innovations for Life Science and Healthcare Summit taking place June 13–14, in Philadelphia will feature 35+ speakers who aim to examine the balance between pragmatic considerations of blockchain and AI applications with forward-thinking conversations about operationalizing innovative technologies, including:

Leslie Cousens, Associate Director, Translational Medicine and Emerging Innovations at ASTRAZENECA, will present AstraZeneca’s open innovation approach to collaborations that foster novel discoveries and speed the development of new medicines for patients in need. She will outline AZ’s program for translational bioinformatics approaches to gain insight into novel connections between drugs and indications for the repositioning discontinued…


Engage With an MHRA Inspector at the European TMF Summit

As you know, the MHRA has been the leading driver when it comes to the trial master file. They have not only been at the forefront of advancing regulations but communicating it as well. To assist in communicating TMF regulations, ExL Events is excited to welcome Andrew Fisher, Senior GCP Inspection from the MHRA, to the 7th European Trial Master File Summit.

Topics discussed during the MHRA presentation include:

Learn what is required to be certified and get updates and clarifications
Discuss when and for which digitised documents certified copy is expected
Discuss pain points and challenges through case examples
Study lessons learned about…


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