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The Rundown: ExL’s Blog

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Message From the Pharmacovigilance Audit and Inspections Conference Chair

It is a distinguished privilege to chair ExL Events’ Pharmacovigilance Audit and Inspections Conference on March 26–27 in Philadelphia. As the conference chairperson, I am eager to welcome you to this benchmark event.

It is my mission to ensure this program equips attendees with skills and practices to adapt and continue to lead the way in complying with global regulations and replicating effective practices in drug safety.

I look forward to learning what lies in store for our work; from new technologies, artificial intelligence, new regulations, and innovative approaches, to ensuring quality and compliance during audits and inspections. To view the full program, 


Ingredients for a Successful Disease Awareness Campaign!

A successful disease awareness campaign will either resonate with patients about the burden of their disease or improve the way HCP educate and engage with their patients around a disease state. Educational and impactful messaging for a successful campaign requires a deep understanding of the patient’s journey and knowledge gaps about a particular disease state.

The Disease Awareness Campaigns Forum, April 4–5, in Philadelphia, will be two days for marketing, communications, and patient/HCP engagement professionals to discuss strategies for building better disease education campaigns. Here are some of the strategies the…


CROWN Congress and Proactive GCP Compliance in Applied Clinical Trials!

Check out a great article by Applied Clinical Trials, interviewing Kevin Hudziak following his recent presentation at ExL Events’ CROWN on Eli Lilly’s patient engagement initiatives. The interview was conducted by a previous CROWN presenter, Moe Alsumidaie, too!

When asked to explain changing patient behaviors, Husziak said, “Patients and patient communities/advocates are becoming empowered to take a more active role in healthcare, and the digital world is altering the way that people seek healthcare information. Patients are also self-identifying for clinical trials.”

He continued, “They are educated and knowledgeable…


Cytel at the Adaptive Clinical Trials Symposium — Download Complimentary Cytel Whitepaper: Adaptive Trial Accelerates FDA Approval

An average clinical trial can cost $60–80 million. Adaptive design allows a sponsor to modify multiple parts of a trial without incurring additional costs. Using this innovative method will present the opportunity to stipulate collected data at various intervals in order to adjust one or more detailed aspects of the study based on analysis of the data. It is proven that this approach will allow a trial to more efficiently demonstrate the effects of a drug.

Take an in-depth look at how Cytel assisted Napo Pharmaceuticals to optimize an adaptive speed and control to achieve orphan drug exclusivity protection. This…


A Message From the Chair of the Central Monitoring Summit

The Central Monitoring Summit, scheduled for March 22–23 in Philadelphia, has an outstanding list of expert presenters who will deal with the complex issues we must face while exploring the challenges, impacts, and implications of risk-based monitoring. Subjects such as the updated ICH E6 (R2) Guidelines, implementing central monitoring, and the shifting role of a CRA are just some of the topics to be addressed during this meeting. This conference presents an opportunity to examine the present status and future direction of RBM and central monitoring. You can view the full agenda here.

As conference chair of…


FDA Data Transparency: How Will Your Development Pipeline Benefit?

Frequently, new formulation approaches end up disappointing the industry because, instead of a breakthrough, they yield slow, incremental development. Is there anything on the horizon that can truly accelerate your drug pipeline? As The Washington Post reports, just a few weeks ago, FDA announced a pilot program to release more detailed study reports from clinical trials. This initiative should quickly provide drug development teams with a much larger library of information about safety and efficacy results to guide their own R&D. How is your company going to take advantage of this new program? Will the drugs you are working…


An Invitation From the MASS East 2018 Conference Chair!

As the conference chair for MASS East 2018, I would like to invite you to join us in New Brunswick, NJ, on April 9–11 for this innovative and collaborative event. This forum is the ideal meeting place for you and your team members to exchange strategic and operational insights with your industry peers and hear how to optimize the overall quality and effectiveness of your medical operations.

This year’s program hosts a diverse speaking faculty of industry leaders responsible for medical affairs, field activities and Investigator-Initiated Trials. They will offer thought-provoking discussions and actionable solutions for managing medical affairs…


Applied Clinical Trials Shares Updates From CROWN Congress

Our friends over at Applied Clinical Trials Online recently shared updates gleaned from attending ExL Events’ January 2018 CROWN Congress with their audience. This article exemplifies the benefits of attending an ExL conference and we thank the publication for sharing this information.

Applied Clinical Trials shared highlights from the Congress, including the following sessions:

Evaluating the CRO Industry Consolidation and Predictions for What’s Next
David H. Windley, CFA, CPA, Managing Director, Healthcare Equity Research, JEFFERIES LLC

Creating a Digital Patient Recruitment Ecosystem Focused on Patients to Optimize Engagement


Value-Based Strategies for Reimbursement & Formulary Success in PM360 Magazine

Below, you’ll find an excerpt from a recent article featured in the February issue of PM360, praising ExL’s November 2017 event, the Value-Based Strategies for Reimbursement & Formulary Success conference.

The conference focused on market access and payer policies, and speakers from a number of industry giants addressed such issues as the importance of differentiating a product’s value from its therapeutic value; decreasing overall healthcare costs; proactive strategies that expand market access; and solving for the complexities HCPs face that delay patient therapy—especially in the oncology health model. Both public and private…


Prepare for Inspections With the 4th European Clinical Trials Inspection Readiness Summit

You might not have an inspection in two weeks, but if you did, are you prepared? ExL Events’ 4th Clinical Trial Inspection Readiness Summit is in three months, and our expert speaking faculty will help ensure you and your teams are prepared for your next inspection.

At this annual event, you will explore detailed examinations of how to handle an actual inspection, discover how to integrate technology validation into inspection readiness procedures, learn to implement the requirements of ICH E6 R2 within trial management and other related systems, select a vendor that matches the sponsor’s culture, discuss case studies,…


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