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Archive for the ‘ExL Events News’ Category

Final Week to Save for the 6th Promotional Review Committee Compliance and Best Practices — Midwest Conference

The 6th Promotional Review Committee Compliance & Best Practices – Midwest, taking place May 15–17 in Chicago, is a one-of-a-kind event you can’t afford to miss!
Our 2019 conference will cover top strategies for:

Complexity-based tiering of PRC responsibilities
Managing documents access and accuracy in spite of regular turnover
Efficiently leading PRCs amidst high material volume
Maintaining team skills and readiness during mergers, acquisitions, and divestitures

…and MUCH MORE! Download the brochure for more details on what you can gain from attending during this three-day event of networking and education.
Reserve Your Seat Today!
Featured Speakers

Nneka Onwudiwe, Regulatory Reviewer, FDA
Bradley Coushman, Vice…


Attendee’s Takeaways: 5th Clinical Trials Phase I & Phase IIA Summit

Applied Clinical Trials recently shared an attendee’s takeaways from ExL Events’ 5th Clinical Trials Phase I & Phase IIA Summit, which took place this past Autumn.

In this article, Moe Alsumidaie, MBA, MSF (Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member/contributor to Applied Clinical Trials) discusses the following three subjects and how ExL’s conference explored them:

Adaptive design in protocol writing

Designing safer early phase studies

Monitoring oversight in early phase trials

For a more complete look at these topics and to learn more about our Clinical Trials Phase I &…


6th Promotional Review Committee and Compliance and Best Practices — Midwest Conference Brochure Available NOW

At the 6th Promotional Review Committee and Compliance and Best Practices — Midwest Conference on May 15–17 in Chicago, attendees will network with over 20 industry experts from Takeda, Alkermes, AbbVie, Genentech, GSK, and more. This is an educational environment with a full day dedicated to workshops and 15 sessions exploring ways to improve PRC teamwork and speed while maintaining expertise even with changes in team composition and regulatory expectations.
View The Brochure
Featured Sessions on Optimizing PRC Training and Teamwork:
Properly Sequence Input From Medical Reviewers
Alexander Shaw, Manager, Medical Information, Alkermes

Select and Implement CAPAS From Promotional Review


Brochure Released: AI Innovations for Life Science and Healthcare Summit East

The agenda for the AI Innovations for Life Science and Healthcare Summit East is now complete! Join our expert speaking faculty of over 30 life science, healthcare, and tech professionals on June 13–14, 2019, in Philadelphia, as we elevate clinical trial operations, healthcare outcomes, and supply chain implementation through AI.
Featured Speakers

Prasanna Rao, Head, Artificial Intelligence and Data Science, PFIZER INC.

Leslie Cousens, Director, Translational Medicine, ASTRAZENECA

Brian Martin, Head of AI, ABBVIE

Christine Sawicki, R.Ph., MBA, LSSMB, Director, Specialty Clinical Innovation and Program Development, CVS HEALTH

Christopher Jordan, Chief Technology Officer, CLICK THERAPEUTICS

Maria Palombini, Director,…


Join 110+ Clinical Quality and Operations Professionals in Philadelphia, March 18–20

There’s still time to register for next week’s 10th Proactive GCP Compliance Conference that is taking place on March 18–20 in Philadelphia. With a focus on ICH E6 R2 compliance, gain the foundation needed to determine your company’s level of compliance and where you should focus your efforts to achieve a confident state of inspection readiness.

Session topics include:

Risk Identification
Risk Control and Communication
Risk Review and Reporting
Monitoring Post R2 Essential Documentation
CRO Oversight
Root Cause Analysis and CAPA
Quality Culture…


“Technology Optimized Content” — 6th PRC Panel Moderator Reflects on Conference

In a new article for titled “Technology Optimized Content,” Ilyssa Levins (President of the Center for Communication Compliance) reflected on her experience as an attendee of and panel moderator at ExL Events’ recent 6th Promotional Review Committee Compliance & Best Practices conference.

The article points out that content quality optimization is dependent upon the promotional material’s ability to obey the following guidelines:

Do not violate any well-established requirements that are not risk tolerance issues
Address FDA guidances which include many sub-requirements
Have no editorial and grammatical errors or typos

Levins also touches on topics like The Value of Technology, High-Tech…


Key Takeaways From the 2nd Pharma Marketing Forum Via Conference Speaker/Track Chair

ExL Events thanks conference speaker and track chair Matthew Smith, Global Lead, strategy Digital Operations at Pfizer, for sharing his takeaways from the 2nd Pharma Marketing Forum, which took place February 25–26 in Philadelphia. In his recent LinkedIn post, Smith “boils” down the themes of the conference into two main subjects: Russia and Trust. 

He goes into a bit more detail, splitting the “Russia” theme into four talking points:

Change management

From there, he explains where “Trust” comes into play. So, find out what Smith’s takeaways from the2nd Pharma Marketing Forum


3rd EU Clinical Quality Oversight Forum Sponsor Shares Conference Reflection

In the spirit of collaboration, a sponsor and attendee of ExL Events’ recent 3rd European Clinical Quality Oversight Forum (25–26 February 2019) has shared some personal observations via their LinkedIn this week. Adam Wood, VP of Business Development at myClin, is furthering his participation in the conference by sharing his thoughts on the following topics:

Inspector Access to the TMF
All TMFs are hybrid
Standalone Inspections of eClinical Vendors
Nightmare Email Trails 

While the conference has already come to a close, there’s still more to gain from it, thanks to participants like Adam! Read the myClin VP’s notes on the conference over…


TMF Education Comes to San Francisco — May 14–15

After nine years of producing Trial Master File educational events, ExL is proud to announce our West Coast premiere — the TMF Institute — San Francisco, taking place on May 14–15, 2019.

During these nine years of producing the TMF Summits in the United States, United Kingdom, and Japan we identified an educational gap, which the Institutes have been able to bridge since they were introduced into the marketplace last year.

This Institute has four tailored courses covering multiple areas of responsibility. Industry leaders teach the course through workshop-style sessions, interactive discussions, and exercises that replicate real-life scenarios. Attendees will…


A Message From the Chair of ExL’s 2nd Adaptive Clinical Trials Symposium

he Chairperson of ExL Events’ 2nd Adaptive Clinical Trials Symposium, Kinjal Patel, recently shared a message about the March 18–19, 2019, event taking place at Sonesta Philadelphia Rittenhouse Square in Philadelphia, PA. Read on to find out what Bayer’s Senior Study Manager of Research and Development had to say!
As the Chairperson of the 2nd Adaptive Clinical Trials Symposium, I would like to invite to you to join our peers from across the industry at this spectacular event, taking place March 18–19 in Philadelphia!

What I am most excited…


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