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The Rundown: ExL’s Blog

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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…


Why the REMS Summit Has Been the Industry’s Leading Choice for Over a Decade!

For over a decade, pharmaceutical specialists, healthcare providers, pharmacists, and regulatory agency professionals have depended on ExL Events’ REMS Summit to provide expert insights into new and pending FDA regulations, introduce technologies that relieve the REMS burden from key stakeholders, propose strategies to facilitate benefit-risk counseling, streamline health system integration, and ultimately advise methods that increase patient safety through cross-industry collaboration.

Since the inaugural REMS Summit in 2007, over 500 pharmaceutical, healthcare provider, and regulatory professionals have attended our highly acclaimed series. The event has tripled in size and continued to evolve alongside the marketplace. We invite you to witness firsthand…


2nd Adaptive Clinical Trials Symposium Brochure Released!

ExL Events is excited to announce the release of the highly anticipated brochure for the 2nd Adaptive Clinical Trials Symposium, which takes place March 18–19 at the Sonesta Hotel in Philadelphia.

Download the Brochure Now!

During this two-day Summit, industry professionals will convene to further educate the important aspects when utilizing these major benefits and implementing this innovative design, such as reducing the trial length and obtaining more precise conclusions for the benefit of trial participants.

Through interactive sessions, panel discussions, and case studies, the 2nd Adaptive Clinical Trials Symposium will explore the unconventional progression behind developing, using…


Q&A: Melissa Paige, UVA Health Systems’ Pharmacy Patient Medication Assistance Principal Coordinator

It is imperative for healthcare organizations to stay on top of the latest information, advancements, and processes related to real-time benefit check. For this reason, we’re excited for you to join us on February 25–26 in Austin for the 2nd Real-Time Benefit Verification and Electronic Prior Authorization Forum. Our faculty of industry experts will be on hand to share actionable insights and content with you — download the brochure to see all of the informative sessions on this year’s program.

Recently, we had the opportunity to chat with one of our speakers — Melissa…


ExL Kicks Off 2019 With Co-Located TMF & CROWN Conferences!

ExL is proud to kick off 2019 with the TMF & CROWN events in Orlando, FL, on January 22–24, 2019, with 400 clinical and data professionals dedicated to enhancing clinical trials through new technologies, innovative data strategies and a streamlines TMF process. With these two industry-leading clinical events co-located in one venue, this is sure to be the networking opportunity people will be talking about all year.

The 8th CROWN Congress is a dynamic three-day program — an elite gathering of clinical decision makers who are challenging the status quo. With more than 30 sessions,…


Discounted Rates Expire This Friday for the European Clinical Quality Oversight Forum!

Maximise your 2019 event budget by registering for the 3rd European Clinical Quality Oversight Forum by this Friday 11 January to take advantage of Early Bird rates to save £100. 

Click here to register!
Featured Presentations
Understand What to Expect During an MHRA Inspection and Know How to Best Prepare
Paula Walker, Inspectorate Unit Manager for GCP/GPvP/GLP, MHRA

Leverage Limited Resources to Effectively Select and Qualify Clinical Trial Vendors to Mitigate Risk
Christiane Helmrich, Ph.D., Head of Quality Assurance Product Development, MEDAC GMBH
Anja Klein, Ph.D., Head of Clinical Project Management, MEDAC GMBH



Take Advantage of Discounted Pricing for the 2nd Pharma Marketing Forum

The 2nd Pharma Marketing Forum, taking place February 25–26 in Philadelphia, is a not-to-be-missed program covering top strategies to enhance your traditional and digital marketing strategies. Early Bird Pricing Ends THIS Friday, January 11! Register Now!

Use Priority Code 762919EM6 when registering.
Over the course of two days, attendees will learn:

The best practices to implement and enhance your various marketing strategies
How to ensure that your organization is following all regulatory and compliance standards while developing an effective campaign
How to adapt your programs to multichannel and global approaches

…and MUCH MORE! Download the brochure to see what you can gain from attending.



Available Now: The 10th Annual Proactive GCP Compliance Conference Brochure!

In our 10th year, the Proactive GCP Compliance Conference agenda is mapped to relevant sections of ICH E6 R2 to provide you with practical tools for achieving and maintaining compliance. Join your peers on March 18–20 in Philadelphia.

Register by February 1 for maximum savings. Click here for more information and to register.

Joanne Spallone, Global Development Quality Audit Head, NOVARTIS

Deb Driscoll, Vice President, Quality Assurance, MERCK RESEARCH LABS PHARMACEUTICALS

Dave Nickerson, Head of Clinical Quality Management, EMD SERONO

Michele Weitz, Senior Director, GCP Compliance Operations, CLOVIS ONCOLOGY

Nancy Bitters, Interim Head of…


Identify FDA Impact on REMS

The FDA has taken significant strides to improve REMS in terms of patient safety and access. At the 11th Risk Evaluation & Mitigation Strategies Summit, you will have the opportunity to hear firsthand from the FDA to analyze the patient perspective in regards to specific diseases and their treatments, along with the risks and burdens that are critical to patients.

View the full agenda!
Discuss Patient-Focused Drug Development (PFDD) and Potential Relationships to REMS
Sara Eggers, Operations Research Analyst, U.S. FOOD & DRUG ADMINISTRATION — CDER

Emily Freeman, Ph.D., Director, Risk Management Sciences, ABBVIE

Our adept speaking faculty will deliver insights into…


PharmaLeaders on GDPR Update for Global Organization

Friends and colleagues over at PharmaLeaders shared their experience attending ExL Events’ GDPR Update for Global Organization. Dealing with the General Data Protection Regulation (GDPR) since it came into effect in May 2018 is a clear focus for every organization in the industry. That’s why PharmaLeaders agrees that our conference was time and focus well-spent.

U.S. companies who do business with EU residents will be a direct subject to GDPR, as their customers exist under the protections of GDPR. These collaborators and contractors, such as CROs running clinical studies, are required to seek contractual commitments to…


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