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The Rundown: ExL’s Blog

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Life Science Compassionate Access Summit Early Bird Rates Expire Friday!

If you haven’t already reserved your seat for the Life Science Compassionate Access Summit, taking place March 18–19 in Philadelphia, the Early Bird deadline is quickly approaching — Register NOW!

Early Bird rates expire this Friday, February 1!

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Signing up prior to the Early Bird’s expiration will give you access to a $200 discount on your registration. Join companies like UCB, Shire, and Retrophin to discuss the different outlooks and ethical approaches to compassionate use requests.

At this two-day, educational and networking event, attendees will be…

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2nd Adaptive Clinical Trials Symposium Early Bird Prices Expire Friday!

This is the last week to receive $200 off the standard registration rate for the 2nd Adaptive Clinical Trials Symposium, taking place March 18–19 in Philadelphia. Early Bird rates expire this Friday, February 1! Register NOW!

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This event will encompass all that is adaptive design; that includes planning and managing an adaptive trial, FDA guidance and tips to navigate through the gray areas associated with an adaptive design, the role of interim analysis in adaptive design, and much more! Attendees will leave with effective…

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10th Proactive GCP Compliance Conference Early Bird Pricing Ends THIS WEEK

Early Bird Pricing for the 10th Proactive GCP Compliance Conference Ends THIS Friday, February 1! REGISTER TODAY and learn from the following sessions, each mapped to their relevant section of ICH E6 R2, on March 18–20 in Philadelphia.

RISK IDENTIFICATION (ICH E6 R2 5.0.1 & 5.0.2)
Identify Critical Processes and Data, and Their Associated Risks
Cheryl McCarthy, RQAP-GCP, CQA, CBA, Associate Director, R&D Quality and Compliance, BIOGEN

RISK CONTROL AND COMMUNICATION (ICH E6 R2 5.0.4 & 5.0.5)
Define Quality Tolerance Limits and Effectively Communicate These Parameters
Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC

RISK…

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Skills for Managing an eTMF Based on Job Searches

In a recent guest column over on Clinical Leader, Audrey Rossow (A Rossow Consulting, LLC) discussed her findings from job searches using the term “trial master file,” revealing the needed skills for managing an eTMF. You’d think that the listings she found would be quite similar, if not the same in regards to the requirements and skills needed to apply for these positions, but you’d actually be incorrect!

Rossow’s article breaks down the types of positions that come up in this search (including TMF Associate/Coordinator/Manager/Specialist, Clinical Project Associate, and more), and how these listings spelled out…

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Q&A With Ari Tulla, Co-Founder of BetterDoctor; CEO of Quest Analytics

Before he takes that podium at our Medicare Conference 2019, Co-Founder of BETTERDOCTOR and Chief Executive Officer of QUEST ANALYTICS, Ari Tulla, sat down with ExL Events to discuss provider-direct accuracy. Take a look!

READ THE INTERVIEW HERE
ExL’s Medicare Conference will arm attendees with methods and strategies to improve the quality, ratings, member engagement and health system alignment of your Medicare Advantage and/or Dual Eligibles program. Speakers representing health plans, regulatory agencies, and health systems will share experiences and…

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Ingredients for a Successful Disease Awareness Campaign

An effective disease awareness campaign will resonate with the audience concerning the burden of a particular disease state; but how can we measure the impact of something that can be somewhat qualitative?


 
Find out at the 2nd Disease Awareness Campaigns Forum this April – the industry’s only event dedicated to professionals that launch and measure the impact of disease awareness campaigns. Download the brochure here and register using Discount Code 795419LINK for savings!

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Brochure Available for the 3rd Clinical Trial Financial Management Summit

Are you one of the many stakeholders facing challenges related to the rising costs of clinical trials? We invite you to download the brochure for the 3rd Clinical Trial Financial Management Summit, taking place April 1–2, 2019, in Philadelphia.
Brochure Available — Download the Full Agenda!
With trial costs at an all-time high, it is of the utmost importance to drive efficiency and performance across the board. The Summit will feature a live mock-negotiation, robust panel discussions, and educational sessions that bring together professionals from pharma, biotech, research sites, and CROs. The topics will highlight…

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Life Science Compassionate Access Summit Brochure Now Available!

We invite you to download the brochure for the Life Science Compassionate Access Summit, taking place on March 18–19 at the Sonesta Philadelphia Rittenhouse Square in Philadelphia, PA.
BROCHURE IS NOW AVAILABLE — DOWNLOAD NOW!
Join our esteemed faculty as they provide their insight and obligations on compassionate use requests to make the process fast and fair for patients in need. In a transparent clinical trial environment, healthcare providers receive constant communication about trials and alternative treatment under expanded access, also known as compassionate use. These responsibilities will ensure patient safety and expanded access…

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TMF Institute — Frankfurt ANNOUNCED: Download the Brochure!

ExL Events is pleased to announce that the TMF Institute will take place on 18–19 March 2019 at the Sheraton Offenbach Hotel in Frankfurt, Germany. The Institute’s sole purpose is to expand your knowledge and enhance your competencies based on what you and your peers need to know and be able to do, based on your particular role and purview.
Access the detailed agenda here!
To create this landmark professional development opportunity, we coopted what participants liked best about our popular 30+ workshops and seminars offered at our global TMF Summit Series. Guided by our industry research and compelled…

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AGENDA NOW AVAILABLE | 3rd Product Complaints Forum

We are excited to announce our agenda for the 3rd Product Complaints Forum, taking place March 25–26 in Philadelphia, is now available!
Download the Brochure
Featured Speakers

Sharon Perez, Director, Global Medical Safety, NOVOCURE
Bob Miller, Ph.D., Senior VP Quality, GILEAD
Michael Hunn, QA Project Manager, DRAEGER MEDICAL INC.
Rupesh Patel, Director, Product Quality-Product Complaints and Quality Systems, OTSUKA PHARMACEUTICAL

Top Reasons to Attend

Review changes to FDA guidelines to ensure compliance with regulatory authorities and understand how and what to file
Benchmark best practices for trending in order to maximize the results of data management systems
Enhance the customer…

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