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The Rundown: ExL’s Blog

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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…

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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:

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

PATIENT-CENTERED DIGITAL RECRUITMENT
Creating a Digital Patient Recruitment Ecosystem Focused on Patients to Optimize Engagement

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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…

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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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Remain Compliant at the 2018 Off-Label Regulatory Compliance Congress

ExL Events invites you to download the brochure for 2018 Off-Label Regulatory Compliance Congress, taking place on May 21–22 in Herndon, VA. This must-attend event will provide attendees with the guidance and information needed to develop tactics that ensure promotional practices remain compliant with the changing regulatory landscape while advancing public health.
Featured Sessions
Determine How to Reduce Risks Involved in Off-Label Promotion
Richard Liner, Senior Compliance Counsel, BAYER HEALTHCARE

Developing Compliant Strategies in Disseminating Scientific Information to Healthcare Providers: Addressing Risk in a CIA-Focused Environment
Howard Dorfman, Distinguished Visiting Practitioner and Adjunct Professor, SETON HALL…

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Final Week — Early Bird Prices Expiring for Bioavailability Summit!

There’s still time to reserve your seat and get the best pricing for the 7th Drug Formulation, Solubility & Bioavailability Summit (March 26–28, Boston). We want to ensure that you have the BEST rate possible — but hurry, this exclusive rate will expire Friday, February 9!

Don’t miss our full-day seminar on advances in drug delivery; a special analysis on the use of 3D printing for new formulations; and methods for accelerating the preclinical-to-clinical data transition. All this and more from our 20+ industry leaders!

Featured Speakers

Rakesh Dixit, Vice President, R&D, Global Head,…

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Cannabis Partnerships Congress Q&A: Lezli Engelking From FOCUS

Before she takes the podium at our upcoming Cannabis Partnerships Congress, I had the opportunity to sit down with Focus’ Lezli Engelking to discuss cannabis regulations within the federal government and some of the challenges they face in the industry and strategies for overcoming them. The following are excerpts from that Q&A session:

Lezli Engelking

Q&A: LEZLI ENGELKING, PRESIDENT AND FOUNDER, FOCUS

What is the current state of cannabis within the federal government?
Cannabis was made illegal in the United States…

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SURVEY: Identifying the Barriers to Effective Clinical Quality Oversight — View Results!

We surveyed 150 clinical quality, compliance, and operations professionals prior to an October 2017 event, inquiring about their top challenges, concerns, and obstacles relating to effective clinical quality oversight.

CLICK HERE TO ACCESS THE SURVEY RESULTS

QUESTIONS INCLUDED:

• Do you feel your company is ICH E6 R2 compliant?

• What are the biggest barriers, challenges or obstacles related to optimizing quality?

• Do you feel you are effectively documenting/demonstrating vendor oversight?

• Which vendors are the most difficult to oversee?

• What…

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JUST ANNOUNCED: Medical Affairs Strategic Summit (MASS) East 2018!

ExL Events proudly announces the return of the Medical Affairs Strategic Summit (MASS) East, taking place April 9–11, 2018 at the Hyatt Regency New Brunswick, NJ. View the brochure now to see what we have in store for you this year!

This year, attendees can choose to join sessions from the following three tracks for the duration of the conference: Medical Affairs Executive Strategy, MSL Best Practices, and Research Collaborations and Investigator-Initiated Trials. The summit also offers four in-depth, interactive workshops led by industry experts:

WORKSHOP A: Building a Medical Affairs Launch Powerhouse

WORKSHOP B: The Role of an MSL Across the Different Phases of…

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Brochure Download: 2018 Product Recalls Forum

Each year, the number of new drugs and medical devices on the market increases, as does the number of recalls. This year, in Q3 statistics, there were 89 pharmaceutical recalls and 167 medical devices recalls. Are you looking to minimize the number and cost of product recalls? Come join us in Herndon, VA on May 21–22. We invite you to download the brochure for the 2018 Product Recalls Forum!

Featured Speakers

Maureen M. Bernier, Biomedical Engineer, Recall Coordinator, FDA

Joe Falvo, Senior Manager: Postmarket Risk Management, ORTHO CLINICAL DIAGNOSTICS

Pearley Bhambri, Senior Director Global Quality Systems and Post Market Surveillance, HILL-ROM

Alex Patterson, Director Post Market Quality, RESMED

Katherine May, APM Predict…

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